Brain Tumor Adult

26

Review clinical trials related to Brain Tumor Adult. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

EEG-Guided Cognitive Function Preservation in Patients With Brain Tumors

Brain tumors and their surgical treatment may impair cognitive function, affecting patients' quality of life. This prospective single-arm study aims to evaluate the feasibility and clinical utility of an EEG-based neural signal decoding strategy for cognitive function preservation in patients undergoing brain tumor surgery. Participants will undergo standardized neuropsychological assessments together with preoperative, intraoperative, and postoperative electrophysiological recordings. The study will investigate whether EEG-based neural decoding can improve objective cognitive function assessment and support individualized functional preservation during brain tumor surgery.

Participants needed: 10
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: Bo WangUpdated: Jul 13, 2026Locations: 1
Eligibility criteria

Age 18 years to 75 years. [+4]

Severe dysfunction of major organs (heart, lung, liver, or kidney). [+3]

Status: Recruiting

The Impact of Paramedic Training in Simulation on the Experience of Patients Treated for Malignant Brain Tumors in Neurosurgery (IPSIMANON)

The goal of this clinical trial is to demonstrate that simulation training for paramedical staff in neurosurgery departments, in announcing and accompanying patients with a brain tumor, improves patient satisfaction when a (potentially malignant) brain tumor is discovered, compared with usual care. The main question it aims to answer is: \- Are patients more satisfied (as measured by scores on the EORCT IN-PATSAT32 questionnaire) with their neurosurgical hospitalization following the discovery of a brain tumor in centers where paramedics have been trained by simulation? Researchers will compare the results of the EORTC IN-PATSAT32 questionnaire to determine whether paramedic training improves patient satisfaction between simulation-trained and untrained centers. Participants will be asked to complete the EORT IN-PATSAT32 questionnaire at the end of their hospital stay.

Participants needed: 250
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University Hospital, BrestUpdated: Jun 23, 2026Locations: 11
Eligibility criteria

Patient over 18 years of age [+4]

Patients with a personal history of cancer [+1]

Status: Not yet recruiting

Movie-Watching Functional MRI for Mapping Brain Function in Neurosurgical Patients

This research will compare a new type of functional MRI (fMRI) called naturalistic viewing (also called movie watching) to standard clinical fMRI techniques. Standard clinical fMRI currently uses multiple tasks such as reading and responding to words or sentences to determine which areas of the brain are responsible for language. Surgeons can use this information to help plan brain surgeries. This research will help determine if the movie-watching fMRI is equivalent or better than the standard task-based fMRI. If so, it could be useful for planning patients' surgeries in the future, without the need for multiple tasks.

Participants needed: 90
Trial details
Age: 21-70Biological sex: AllType: InterventionalSponsor: Brigham and Women's HospitalUpdated: Jun 22, 2026Locations: 1
Eligibility criteria

Any sex, age between 21 to 70 years; [+6]

Contraindications to MRI: Note: MRI screening will be performed by radiology sta... [+1]

Status: Not yet recruiting

Feasibility Assessment of Adapted Physical Activity in Patients Treated for a Brain Tumor

The goal of this clinical trial is to assess the feasibility of an adapted physical activity (APA) program in adult patients (≥18 years) with primary brain tumors, regardless of tumor type, grade, treatment stage, or the presence of motor, sensory, attention, concentration, or memory deficits. The main question it aims to answer is: What is the effective adherence rate to an APA program among eligible patients with primary brain tumors? Additional questions include: * What is the observance rate (number of sessions completed, intensity achieved, and duration) during the 3-month supervised APA program? * What is the retention rate (proportion of patients completing the program and continuing APA beyond the initial period)? * What is the impact of APA on quality of life, anxiety-depression, and cancer-related symptoms (measured via QLQ-BN20, HADS, and MFI-20 questionnaires at baseline, 3, and 4 months)? Participants will: * Undergo a 3-month supervised APA program (with possible continuation beyond this period). * Use connected watches to monitor physical activity (if they accept the general conditions of use). * Complete self-questionnaires (IPAQ, BREQ-2, QPP, QLQ-BN20, HADS, MFI-20) at inclusion, 3 months, and 4 months. * Be followed for a total of 4 months after inclusion.

Participants needed: 90
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Center Eugene MarquisUpdated: Jun 12, 2026Locations: 1
Eligibility criteria

Men or women ≥ 18 years old, [+6]

WHO score ≥ 3 [+4]

Status: Recruiting

Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM

The purpose of this study is to evaluate the safety and efficacy of administering the medication capecitabine along with temozolomide when you start your monthly regimen of oral temozolomide for the treatment of your newly diagnosed glioblastoma multiforme (GBM). Capecitabine is an oral chemotherapy that is given to patients with other types of cancer. The study will evaluate whether the dosage of 1500 mg/m2 of capecitabine is tolerable after radiation, when taken along with temozolomide. It will also try to determine if the medication capecitabine helps patients respond to treatment for a longer period of time compared to just temozolomide alone, which is the standard of care.

Participants needed: 67
Trial details
Phase: Phase 1, Phase 2Age: 18-74Biological sex: AllType: InterventionalSponsor: Northwell HealthUpdated: Jun 1, 2026Locations: 1
Eligibility criteria

Be capable of giving informed consent. [+9]

Prior chemotherapy with capecitabine or temozolomide for other prior malignancie... [+12]

Status: Not yet recruiting

Evaluating Biomarkers of Cognitive Dysfunction in Patients With Cancer

This study investigates the effects of brain radiotherapy on cognitive function by evaluating plasma biomarkers and apolipoprotein E (APOE) genotype in patients with primary or metastatic brain tumors. Standard brain radiotherapy is known to impact cognitive outcomes, yet the underlying biological mechanisms remain unclear.

Participants needed: 40
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: University of California, San FranciscoUpdated: May 22, 2026Locations: 1
Eligibility criteria

>= 18 years old [+7]

Diagnosis of neurodegenerative disease (Alzheimer's disease, Parkinson's disease... [+2]

Status: Recruiting

Comparison of Skin Closure Techniques in Oncological Neurosurgical Procedures: Intradermal Running Suture Versus Transdermal Interrupted Sutures

The purpose of this study is to compare two commonly used methods of closing the skin after surgery for an intracranial tumor. Skin closure is one of the most important steps in neurosurgical procedures, as it has a major influence on how well the wound heals. In patients with brain tumors, proper wound healing is especially important because it may affect how soon additional treatments, such as radiotherapy or chemotherapy, can be started. There are different ways to close the skin after surgery, including running sutures and interrupted sutures. Both methods are widely used and considered safe. However, in oncological neurosurgery, there is limited scientific evidence comparing their effects, and the choice of technique is often based on the surgeon's personal experience. In this study, investigators will compare skin closure using running absorbable sutures with interrupted non-absorbable sutures. Investigators will evaluate how well, depending on used suturing methods, the wound heals and how often wound-related complications occur, such as infection, separation of the wound edges, or leakage of cerebrospinal fluid. Investigators believe that the results of this study will help improve wound care in patients undergoing neurosurgical treatment for brain tumors and, as a result, may contribute to better recovery and overall quality of life.

Participants needed: 382
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Medical University of WarsawUpdated: May 20, 2026Locations: 1
Eligibility criteria

Male or female at least 18 years old [+1]

Revision surgery due to recurrent brain tumor [+2]

Status: Recruiting

Analysis of Cerebrospinal Fluid Leakage After Surgery for Intracranial Tumors

Cerebrospinal fluid is a clear fluid that surrounds and protects the brain. During surgery for brain tumors, neurosurgeons often need to open the covering of the brain (the dura) to reach the tumor. At the end of the operation, this covering is carefully closed again. In some cases, the closure might not be completely adequate leading to cerebrospinal fluid leak. This leakage may collect under the scalp or flow out through the surgical wound. When this happens, the surgical wound may not heal properly, and the risk of infection can increase. These complications can delay recovery and may postpone additional treatments, such as radiotherapy or chemotherapy, that are often needed after brain tumor surgery. Although cerebrospinal fluid leakage is less common after supratentorial craniotomy (surgery on the upper part of the brain) than after other types of brain surgery, it remains a challenging complication and has not been well studied in this group of patients. The aim of this study is to determine how often cerebrospinal fluid leakage occurs after supratentorial craniotomy for intracranial tumors, identify factors that increase the risk of leakage, and evaluate how these leaks are managed. Understanding these factors may help reduce the occurrence of cerebrospinal fluid leakage and improve postoperative recovery in the future.

Participants needed: 200
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Medical University of WarsawUpdated: May 22, 2026Locations: 1Duration: 6 Weeks
Eligibility criteria

Male or female at least 18 years old [+1]

Revision surgery due to recurrent brain tumor [+1]

Status: Not yet recruiting

PIRe 2.0: A Stepped-Care Model for Involving Relatives Across Sectors

Serious brain diseases and injuries affect not only the person who becomes ill or injured, but also their family. Relatives of people with acquired brain injury (ABI) or malignant brain tumor (MBT) often take on a major role in daily care, decision-making, and coordination across healthcare services. This role can include managing information, supporting rehabilitation, and acting as a link between hospital care and community rehabilitation. Many relatives report high levels of stress, uncertainty, and emotional burden, especially during transitions between care settings. Despite recommendations for greater involvement of relatives, support for this group is often uneven and poorly coordinated across healthcare sectors. Relatives frequently experience lack of overview, limited guidance, and unclear expectations regarding their role. These challenges may increase caregiver burden and negatively affect both relatives' well-being and the continuity of care. The PIRe 2.0 study aims to further test, and implement a structured intervention to support systematic involvement of relatives of people with ABI or MBT across hospital and community rehabilitation services. The intervention is designed as a "caregiver compass" that helps relatives understand their role, clarify their needs and wishes for involvement, and gain better overview of the care pathway. PIRe 2.0 is delivered through a stepped-care model, which allows the level of support to be adjusted over time based on each relative's level of burden and support needs. All relatives receive basic information and screening for caregiver burden using the 4-item Zarit Burden Interview (ZBI-4). Relatives who show signs of increased burden are offered additional support in steps, ranging from structured conversations with nurses to extended cross-sector coordination and specialized support for relatives with high or complex needs. Decisions about stepping up or down are based on both screening results and clinical assessment to ensure flexibility and person-centered care. The study includes two groups of relatives: an intervention group receiving support through the PIRe stepped-care model, and a control group receiving usual care only. A total of 160 relatives will participate. Data are collected at baseline, at transitions between hospital and community care, and three to six months after the intervention. The primary outcome is change in caregiver burden, measured with the Caregiver Burden Scale (CBS). Secondary outcomes include relatives' roles and responsibilities, perceived support and involvement in care, and mental well-being, assessed using validated patient-reported outcome measures. In addition to evaluating the effect of the intervention, the study examines how the PIRe model can be implemented and sustained in everyday practice across healthcare sectors. The results are expected to show whether a structured, stepped-care approach can reduce caregiver burden, improve coordination between hospital and community services, and support more coherent and secure care pathways for people with ABI or malignant brain tumor and their relatives.

Participants needed: 160
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Rigshospitalet, DenmarkUpdated: May 19, 2026Locations: 1
Eligibility criteria

Primary relative of an adult diagnosed with acquired brain injury (ABI) or malig... [+3]

Insufficient proficiency in Danish to complete questionnaires and participate in... [+1]

Status: Not yet recruiting

APT-weighted and Diffusion MRI for Characterizing Tumor Infiltration in High-Grade Gliomas

High-grade gliomas are the most common primary malignant brain tumors and are characterized by infiltration of the surrounding brain tissue beyond the visible tumor margins. This infiltrative growth represents a major challenge for treatment planning and contributes to tumor recurrence. Conventional magnetic resonance imaging (MRI) is limited in its ability to distinguish tumor infiltration from non-tumoral changes such as vasogenic edema in the peri-tumoral region. This prospective single-center observational study aims to improve the characterization of the peri-tumoral microenvironment in patients with suspected high-grade gliomas using advanced MRI techniques, including amide proton transfer-weighted (APTw) imaging and diffusion tensor imaging (DTI). These techniques provide complementary information about tissue composition and microstructure and may help identify areas of tumor infiltration that are not visible on conventional imaging. APTw- and DTI-derived maps will be combined to generate imaging-derived maps describing the likelihood of tumor infiltration within the peri-tumoral region. These maps will be compared with histopathological findings obtained from tissue samples collected during biopsy or tumor resection performed as part of standard clinical care. Histological analyses will include assessment of tumor cellularity using hematoxylin and eosin staining and additional immunohistochemical markers routinely used in neuropathological evaluation. Patients will undergo routine clinical follow-up and the prognostic significance of the imaging-derived map will be assessed. The overall goal of the study is to develop and validate imaging-based biomarkers capable of identifying infiltrated tissue within the peri-tumoral region. These findings may contribute to improved diagnostic accuracy and support future treatment planning strategies in patients with high-grade gliomas.

Participants needed: 20
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: IRCCS Ospedale San RaffaeleUpdated: Apr 15, 2026
Eligibility criteria

Adult patients (both male and female, >= 18 years old) [+4]

Pregnancy (to be excluded through a human chorionic gonadotropin pregnancy test... [+3]

Status: Not yet recruiting

Picture Naming Decoding From Intraoperative Recordings

The clinical investigation evaluates whether speech can be decoded from neural activity recorded with cortical surface electrocorticography (ECoG) electrodes during awake brain tumor surgery. Neural signals and voice recordings are collected while patients perform a picture naming task as part of standard intraoperative mapping. The study assesses the ability of machine learning algorithms to predict the named item from intraoperative electrophysiological recordings.

Participants needed: 20
Trial details
Age: 18-84Biological sex: AllType: InterventionalSponsor: Assistance Publique - Hôpitaux de ParisUpdated: Mar 30, 2026Locations: 1
Eligibility criteria

Patients 18 years of age or older. [+1]

Patients with severe cognitive impairments that would prevent understanding and... [+15]

Status: Not yet recruiting

Real Time Craniotomy Planning Using Mixed Reality

This study is a prospective observational study designed to evaluate the effectiveness of Brainlab's Mixed Reality Viewer in enhancing the accuracy and efficiency of preoperative craniotomy planning. The study will be conducted at a single site with two enrollment groups. Group 1 has a target enrollment of 38 subjects. Group 2 has a target enrollment of 16 subjects. By observing the device's use during standard surgical procedures, we can accurately measure its impact on incision planning accuracy, time efficiency, and overall ease of use compared to traditional neuronavigation systems. This design allows for the collection of both quantitative and qualitative data, providing a robust assessment of the Mixed Reality Viewer's potential to enhance surgical outcome

Participants needed: 54
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Brainlab AGUpdated: Mar 12, 2026Locations: 1
Eligibility criteria

Diagnosis: Patients diagnosed with a brain tumor requiring surgical intervention... [+4]

Inability to Provide Informed Consent: Subject is unable to provide written info... [+7]

Status: Not yet recruiting

Neuromodulation-Induced Cortical Prehabilitation in High Grade Glioma Near the Motor Pathway: Cortical Plasticity Assessed by Navigated Transcranial Magnetic Stimulation (nTMS)

The goal of this clinical trial is to learn whether Neuromodulation-Induced-Cortical-Prehabilitation (NICP)-using physical therapy (constraint-induced movement training, CIM) alone or combined with repetitive transcranial magnetic stimulation (rTMS)-can promote motor-cortex neuroplasticity before surgery in adults with high-grade gliomas near the motor pathway. It will also learn about the feasibility and safety of these prehabilitation strategies around the time of surgery. The main questions it aims to answer are: 1. Does CIM (with or without rTMS) produce measurable motor-cortex plasticity from baseline to pre-surgery as assessed by neuronavigated TMS (nTMS)? 2. Does adding rTMS to CIM lead to greater neuroplastic changes than CIM alone? 3. What clinical, radiological, and neurophysiological outcomes are observed after surgery in participants who receive prehabilitation compared with controls? Researchers will compare standard care (control) vs CIM-based physical therapy vs CIM plus rTMS to see if these approaches induce preoperative neuroplastic changes that may support better surgical outcomes. Participants will: 1. Be randomized to one of three groups: control, CIM physical therapy, or CIM + rTMS• Undergo nTMS motor mapping and excitability testing at baseline (T0) and the day before surgery (T1) 2. Undergo planned tumor surgery (according to standard methods of care) and complete postoperative clinical, imaging, and neurophysiological follow-up assessments.

Participants needed: 63
Trial details
Age: 18-80Biological sex: AllType: InterventionalSponsor: Azienda Sanitaria dell'Alto AdigeUpdated: Mar 13, 2026
Eligibility criteria

Age 18-80 [+4]

Refusal to Study participation [+1]

Status: Recruiting

Chinese-Specific Speech Imagery Coding Using High-Density ECoG

The goal of this study is to investigate whether high-density electrocorticography (ECoG) signals recorded from the surface of the brain can be used to decode neural representations of Mandarin Chinese speech features, including lexical tone, without requiring overt speech movements. The study focuses on the development and evaluation of decoding algorithms based on neural activity recorded during clinically indicated neurosurgical procedures. The main questions it aims to answer are: Can high-density ECoG signals be decoded to reconstruct neural representations of Mandarin Chinese speech features, particularly lexical tone? Can neural activity recorded during silent auditory speech imagery be decoded to reconstruct tone-specific speech representations without actual articulation? The study includes two groups of adult patients with neurological conditions who require cortical electrode placement as part of clinically indicated care: A intraoperative high-density ECoG temporary coverage group, enrolling approximately 50 patients with functional-area glioma or drug-resistant epilepsy who undergo awake neurosurgery with temporary high-density ECoG coverage for clinical functional mapping. A permanent high-density ECoG implantation group, enrolling approximately 10 patients with severe speech or language impairment caused by neurological conditions such as stroke, brain tumors, amyotrophic lateral sclerosis (ALS), or locked-in syndrome, who receive permanent high-density cortical electrode implantation for long-term monitoring. Participants will: Complete preoperative clinical assessments as part of standard medical care, including brain imaging, language function evaluation, and routine neurological assessments Undergo clinically indicated awake neurosurgical procedures during which high-density ECoG electrodes are placed on the cortical surface for clinical functional localization Perform language-related tasks, such as listening to speech, imagining speech, and limited spoken responses, while brain electrical activity is recorded for approximately 20-30 minutes during surgery, without altering standard surgical procedures For participants in the permanent implantation group, participate in long-term follow-up visits approximately every 2 weeks or monthly for up to 12 months after surgery, including evaluation of signal quality and research-related analysis and optimization of decoding algorithms All surgical procedures involving temporary or permanent electrode placement are performed for clinical indications and have been approved through institutional ethical and scientific review. Participation in this study does not alter standard clinical care for the temporary recording group and does not require additional clinical procedures beyond routine treatment. This research aims to support the long-term development of silent brain-to-speech communication technologies for individuals with severe speech or motor impairments and to improve understanding of how frontal, parietal, and temporal brain regions represent imagined speech in tonal languages such as Mandarin Chinese.

Participants needed: 50
Trial details
Age: 20-80Biological sex: AllType: InterventionalSponsor: Second Affiliated Hospital, School of Medicine, Zhejiang UniversityUpdated: Mar 10, 2026Locations: 1
Eligibility criteria

Age between 20 and 80 years. [+10]

Significant mass effect with severe intracranial hypertension precluding awake c... [+6]

Status: Recruiting

Metabolic Characteristics of Brain Tumors Using Hyperpolarized Carbon-13 Magnetic Resonance Spectroscopic Imaging (MRSI)

This is a non-randomized, purely observational, feasibility study to detect metabolic changes in patients with brain malignancy using a novel hyperpolarized \[1-13C\]pyruvate MRSI.

Participants needed: 25
Trial details
Age: 18-70Biological sex: AllType: ObservationalSponsor: University of Texas Southwestern Medical CenterUpdated: Mar 10, 2026Locations: 1
Eligibility criteria

Definitive diagnosis of brain tumors by imaging which demonstrates all kinds of... [+4]

Subjects who are receiving any other investigational agents. [+18]

Status: Recruiting

Cancer-related Fatigue and Its Biological Contributors in Adolescent and Young Adult Brain Tumor Survivors: Effects of a Tele-exercise Intervention

The goal of this research study is to learn about the effects of the RISE-YA intervention on cancer-related fatigue in young adults who are brain cancer survivors.

Participants needed: 75
Trial details
Age: 18-39Biological sex: AllType: InterventionalSponsor: M.D. Anderson Cancer CenterUpdated: Mar 4, 2026Locations: 1
Eligibility criteria

Is currently between the ages of 18-39 years [+8]

Non-English speaking [+8]

Status: Not yet recruiting

B7-H3.CD28Z.CART in CNS Neoplasms

The purpose of this research study is to test the safety and effectiveness of a cell therapy at different doses for children and young adults with recurrent or progressive brain tumors. Recurrent/recurred means a tumor that has gone away and then came back. This cell therapy is called B7- H3.CD28Z.CART, referred to as B7-H3 CAR T cells. B7-H3 is a protein that is over-expressed on many tumor cells, making it a good target for cancer cell therapy. The names of the study investigational therapies involved in this study are: * Fludarabine (a type of chemotherapy) * Cyclophosphamide (a type of chemotherapy) * B7-H3 CAR T cells (a type of cellular therapy)

Participants needed: 70
Trial details
Phase: Phase 1Age: 2-21Biological sex: AllType: InterventionalSponsor: Robbie MajznerUpdated: Feb 5, 2026Locations: 2
Eligibility criteria

Participants must have histologically and/or molecularly confirmed CNS embryonal... [+55]

Tumor with diameter of >5cm in one dimension on T2/FLAIR sequence [+18]

Status: Not yet recruiting

Intraoperative Ultrasound for Brain Tumor Surgery Enhanced by AI

Intraoperative ultrasound is a versatile, low-cost imaging tool that has been shown to improve safety and efficacy in brain tumor surgery. However, its widespread adoption remains limited due to operator dependency, the complexity of image interpretation, the presence of artifacts, and a restricted field of view. This project aims to prospectively evaluate, in a multicenter and non-randomized setting, a prototype real-time deep learning-based segmentation model for brain tumor delineation in intraoperative ultrasound. The model is designed to facilitate the identification of tumor tissue during surgery, potentially enhancing intraoperative decision-making and surgical precision. By increasing the precision and accessibility of ioUS, this innovation is expected to enable safer and more complete resections, with the potential to improve both survival and quality of life for patients with brain tumors.

Participants needed: 100
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Hospital del Rio HortegaUpdated: Jan 29, 2026
Eligibility criteria

Age ≥ 18 years. [+3]

Status: Recruiting

Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures

This research is studying a device already approved by the Food and Drug Administration (FDA) to treat wound closures. Researchers are studying a large group of people to continue to learn information about the safety of the STRATAFIX suture and how people's bodies react to using it over a long period of time. This research will provide additional information about using STRATAFIX sutures to close surgical wounds.

Participants needed: 160
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: University of MichiganUpdated: Nov 5, 2025Locations: 1
Eligibility criteria

Elective or emergent surgical approaches for cranial or spine neurosurgical appr...

Patients with prior surgical wound dehiscence or infection [+1]

Status: Recruiting

AI-assisted Diagnosis of Malignant Brain Tumors

This study aims to establish a large-scale, multi-center MRI database for malignant brain tumors. It will develop an artificial intelligence system for the segmentation and classification of multiple subtypes of brain tumors (including glioma, metastatic tumor and lymphoma et al.) using deep learning technology. This will address the issues of small sample sizes and limited classification performance in existing methods, thereby improving the accuracy of non-invasive preoperative diagnosis, reducing the need for biopsies, and having significant clinical translational value.

Participants needed: 3,000
Trial details
Age: 18-100Biological sex: AllType: ObservationalSponsor: Second Affiliated Hospital, School of Medicine, Zhejiang UniversityUpdated: Sep 30, 2025Locations: 2
Eligibility criteria

Patients diagnosed with glioma, brain metastases, and brain lymphoma by patholog...

Poor image quality; history of previous brain surgery or radiotherapy; accompani...

Status: Recruiting

Focused Ultrasound Blood-Brain Barrier Disruption for the Treatment of High-Grade Glioma in Patients Undergoing Standard Chemotherapy

The goal of this clinical trial is to evaluate the safety and feasibility of focused ultrasound (FUS)-mediated blood-brain barrier (BBB) disruption using the Next Generation Dome Helmet (NGDH) in adults with glioblastoma (GBM) undergoing the maintenance phase of the standard "Stupp protocol". Participants will: * Undergo repeated FUS BBB disruption treatments during the maintenance phase of temozolomide (TMZ) chemotherapy. * Receive intravenous ultrasound contrast (DEFINITY®) prior to each FUS session to facilitate targeted BBB disruption. * Undergo serial MRI scans and clinical assessments to evaluate safety and the extent of BBB opening. * Provide blood samples (and tumor tissue if available) for biomarker analysis related to BBB permeability, tumor presence, and treatment response. * Be followed for progression-free survival (PFS) and overall survival (OS) during routine neuro-oncology visits until end of life.

Participants needed: 10
Trial details
Phase: Phase 1Age: 18-85Biological sex: AllType: InterventionalSponsor: Sunnybrook Health Sciences CentreUpdated: Sep 17, 2025Locations: 1
Eligibility criteria

Age between 18 and 85 years, inclusive. [+7]

The subject presents with symptoms and signs of increased intracranial pressure... [+28]

Status: Recruiting

The Analgesic Effect of Scalp Nerve Block Using Bupivacaine Liposomes for Postoperative Pain Relief After Craniotomy

After undergoing craniotomy, 60% to 84% of neurosurgery patients experience moderate to severe acute pain, primarily in the first 48 hours. This pain is mostly superficial, affecting the muscles and soft tissues around the skull. Poor pain management can lead to complications such as restlessness, nausea, hypertension, increased intracranial pressure, and prolonged recovery, potentially resulting in chronic headaches. Opioids are commonly used to manage this pain but can cause significant side effects like sedation, nausea, and increased intracranial pressure, which can mask serious conditions. Non-opioid medications and scalp infiltration techniques can help but may not provide sufficient pain relief for the duration needed. Currently, multimodal analgesia, particularly scalp nerve blocks, is advocated in neurosurgical recovery practices. These blocks are effective and simpler to perform, but the effects of long-acting local anesthetics, like bupivacaine, typically last only 24 hours. Since pain often persists longer than that, there is a need for better pain management strategies. Liposome bupivacaine is a new long-acting local anesthetic approved by the FDA, offering pain relief for up to 72 hours compared to regular bupivacaine's 8-hour duration. Its effectiveness has been confirmed in various nerve block procedures, but it has not been reported for scalp nerve blocks. This study aims to investigate whether liposome bupivacaine scalp nerve blocks can provide long-lasting postoperative pain relief, promote quicker recovery, and reduce complications in neurosurgery patients.

Participants needed: 218
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Zhejiang UniversityUpdated: Jul 3, 2025Locations: 1
Eligibility criteria

Age ≥ 18 years [+3]

Preoperative Glasgow score < 15 [+14]

Status: Recruiting

Processed EEG for Monitoring of Anesthetic Depth in Intracranial Tumor Surgery

An important feature of neurosurgical anesthesia is early postoperative recovery of consciousness with minimal residual sedation. This is a key factor to enable early neurological assessment and early discovery of postoperative complications. The goal of this single centre clinical trial is to compare propofol/remifentanil anesthesia delivered by manual total intravenous anesthesia (mTIVA) or target controlled infusion (TCI) for intracranial tumor resection via craniotomy. Anesthetic depth will be assessed by a simplified processed EEG (pEEG). The main question is time spent within recommended pEEG- levels from anesthesia induction until end of surgery. Secondary questions are: * mean pEEG-level, time from end of surgery to consiousness, * peroperative propofol/remifentanil consumption * postoperative degree of sleepiness * awareness assessment Participants are adults having have planned surgery for open resection of a brain tumor and will receive general anesthesia with propofol and remifentanil randomized to mTIVA or TCI. pEEG vill be blinded. * Participants will be asked to grade postoperative sleepiness using a specific scale * Follow up regarding awareness will be performed.

Participants needed: 126
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Region SkaneUpdated: Apr 10, 2025Locations: 1
Eligibility criteria

Elective craniotomy for tumor resection [+2]

Cognitive impact affecting infrmed consent [+1]

Status: Recruiting

Assessment of Tiredness During Awake Resection of Intracerebral Tumors

Occasional patients with intracranial tumors need to have a planned awakening during surgery to avoid major disability from the tumor resection. During the awake part of the surgery an increasing degree of tiredness is observed. For the surgeon to plan the resection knowledge of the degree and speed of tiredness/sleepiness evolution is important. The goal of this single center study is to use the "Karolinska Sleepiness Scale" during and after awake surgery for neurosurgical tumor resection to quantify the time available for surgical intervention. Participants are adults having planned surgery for open resection of intracranial tumor with a planned awakening for assessment during surgery. Participants will be asked to grade postoperative sleepiness using the "Karolinska Sleepiness Scale".

Participants needed: 10
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Region SkaneUpdated: Apr 10, 2025Locations: 1
Eligibility criteria

Adult (>18 years old) [+3]

Tumor resection without awake surgery [+1]

Status: Recruiting

Electroencephalogram Predicts Post-operative Delirium

The goal of this observational study is to investigate the predictive value of sub-hairline electroencephalography (EEG) during anesthesia recovery for postoperative delirium (POD). The main question to be answered is: * Can sub-hairline EEG measured during anesthesia recovery serve as a reliable predictor of POD? Adult patients undergoing elective craniotomy and admitted to the ICU will be enrolled. Sub-hairline EEG will be monitored until ICU discharge.

Participants needed: 137
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Beijing Sanbo Brain HospitalUpdated: Mar 25, 2025Locations: 2Duration: 30 Days
Eligibility criteria

Age ≥ 18 years [+3]

Known neurological or psychiatric disorders (e.g., epilepsy, Parkinson's disease... [+6]