Effects of Transcranial Electrical Stimulation on Cognitive Impairment in CNS Inflammatory Demyelinating Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorXuanwu Hospital, Beijing
About this trial
Background: Central nervous system inflammatory demyelinating diseases often lead to significant cognitive impairment, presenting a critical challenge in patient management.
Objective: To evaluate the effectiveness of individualized transcranial electrical stimulation (tES) in improving cognitive function among patients with inflammatory demyelinating disorders.
Methods: This study will assess cognitive performance through standardized neuropsychological assessments before and after individualized tES intervention, measuring changes in cognitive domains including memory, attention, executive function, and processing speed.
Anticipated Results: the investigators hypothesize that personalized transcranial electrical stimulation will demonstrate significant improvements in cognitive performance, potentially offering a non-invasive therapeutic approach for managing cognitive decline in central nervous system inflammatory demyelinating diseases.
Significance: This research may provide novel insights into neuromodulation strategies for cognitive rehabilitation in patients with complex neurological conditions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with Neuromyelitis Optica Spectrum Disorders (NMOSD), Multiple Sclerosis (MS), and other Central Nervous System Inflammatory Demyelinating Diseases that meet diagnostic criteria;
Patients with SDMT scores <55 or subjective cognitive decline;
Age between 18 and 65 years, gender unrestricted;
Hamilton Anxiety and Depression Scale scores <7 points for both scales;
Disqualifiers
Relapse record within the past month;
Medication adjustment within the past month or having undergone modified electroconvulsive therapy, transcranial magnetic stimulation, or other neuromodulation techniques;
Participating in any other clinical research within 1 month prior to enrollment or currently;
Presence of cochlear hearing aids, cardiac pacemakers, or implanted brain stimulation devices;
Trial design
Design model
Parallel
Treatments tested in this trial
tES
Devicehis study employs a randomized controlled trial (RCT) design, randomly dividing eligible participants into a neuromodulation group and a sham neuromodulation group. Neuromodulation Group: Receive individualized transcranial electrical stimulation (tES) treatment Combined with cognitive training Stimulation parameters: Total current: approximately 2mA Duration: 21 minutes Electroencephalogram (EEG) and functional MRI (fMRI) monitoring before and after electrical stimulation
tES
DeviceUse the same device and procedure as the neuromodulation group Stimulation device automatically turns off after 30 seconds Maintain device connection Design creates similar initial sensations to actual stimulation Maintains the double-blind nature of the study
Treatment groups
85 Participants
are divided into 2 treatment groupsGroup A: Neuromodulation GroupActive comparator 1 intervention
Group B: sham Neuromodulation GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cognitive Assessments
AVLT, Auditory Verbal Learning Test AVLT score is higher, the better.
Time frame
Before treatment, on the last 1 day of treatment, and one month after treatment.Secondary outcomes
1
SDMT
symbol digit modalities test, SDMT score is higher, the better."
Time frame
Before treatment, on the last 1 day of treatment, and one month after treatment2
Improvement in EEG Parameters
the power spectral density (PSD) of delta, theta, alpha, beta, and gamma waves; t Default Mode Network (DMN), Sensory Motor Network (SMN), Visual Network (VN), Auditory Network (AN), Cognitive Control Network (CCN), Salience Network (SN), and Dorsal Attention Network (DAN); the intranetwork connectivity within these networks; and the internetwork connectivity between these networks.
Time frame
Before treatment, on the last 1 day of treatment, and one month after treatment3
Improvement in fMRI Parameters
Default Mode Network (DMN), Sensory Motor Network (SMN), Visual Network (VN), Auditory Network (AN), Cognitive Control Network (CCN), Salience Network (SN), and Dorsal Attention Network (DAN); the intranetwork connectivity within these networks; and the internetwork connectivity between these networks.
Time frame
Before treatment, on the last 1 day of treatment, and one month after treatmentSponsors and contacts
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Source ClinicalTrials.gov