Prediction of Effectiveness of rTMS Application in Alzheimer's Patients
ConditionAlzheimer Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorIstanbul Medipol University Hospital
About this trial
Since pharmacological methods are insufficient in the treatment processes of Alzheimer's disease, non-pharmacological methods such as Transcranial Magnetic Stimulation (TMS) have started to be tried as a treatment option as in other neurological and psychiatric diseases. Repeated (rTMS) offers a potential treatment pathway for neurological and psychiatric illnesses. rTMS benefit rate may vary depending on many factors such as the region where it is applied, the progression and the disease degree. The possible effects of TMS on Alzheimer's pathophysiology and modification of disease process (neuroprotective, anti-inflammatory and antioxidant) will also be revealed through blood samples taken from patients before and after treatment. These approaches also constitute the original value of our study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have been diagnosed with clinical Alzheimer's Disease in accordance with the NINCDS-ADRDA diagnostic criteria
>55 years old
Clinical Dementia Rating Scale (CDR) score in the 1-2 range
Not having any other disease that affects their cognitive functions
Disqualifiers
Participant or relative does not give consent
The patient's inability to participate in the entire study procedure (eg living in another city)
The patient's history of head trauma with alcohol/substance abuse
Presence of severe stroke and other neurological sequelae disease in the participant
Trial design
Design model
Parallel
Treatments tested in this trial
Repetetive Transcranial Magnetic Stimulation
Device.Power Mag TMS device will be used throughout the study, and the excitations will be made with the help of an 8 shaped coil (diameter: 70 mm) with internal cooling. The right-left DLPFC, which is the application area, will be determined with the help of the primary motor hand area and the 10/20 EEG system. A resting state EEG (eyes open-closed) will be taken in the Faraday cage. The same procedures will be done with the sham coil in the control group.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: InterventionalExperimental treatment 1 intervention
Group B: ShamSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
The Mini Mental State Examination
Cognitive Neuropsychological Test Score
Time frame
Changes Before Treatment and 1 month after treatment2
Neuropsychiatric Inventory
Cognitive Neuropsychological Test Score
Time frame
Changes Before Treatment and 1 month after treatment3
Alzheimer's Disease Assessment Scale
Cognitive Neuropsychological Test Score
Time frame
Changes Before Treatment and 1 month after treatment4
ADSL
Cognitive Neuropsychological Test Score
Time frame
Changes Before Treatment and 1 month after treatmentSecondary outcomes
1
Blood samples ELISA analyses
BDNF:measured spectrophotometrically with commercially purchased ELISA kits. GDNF:measured spectrophotometrically with commercially purchased ELISA kits. Exosome: measured spectrophotometrically with commercially available ELISA kits. Anti-inflammatory Cytokines: IL-1β, IL-6, TNF-α, IFNy, NF-kβ values will be measured spectrophotometrically with commercially purchased ELISA kits.
Time frame
Changes Before Treatment and 1 month after treatment2
Blood samples analyses
OSI:TOS and TAS will be measured by photometric methods. OSI will be found by mathematical calculation. Total thiol and native thiol concentrations are measured spectrophotometrically in separate solutions prepared for the determination of the thiol-disulfite ratio, which is another indicator of oxidative stress, and the amount of disulfide is determined according to the mathematical ratio between them. Albumin Globulin Ratio:measured by electrophoresis method and albumin globulin ratio will be determined. Omega 6/3 Levels:determined by commercially purchased lipid mediators.
Time frame
Changes Before Treatment and 1 month after treatment3
Inflammatory Biomarker analyses
Inflammatory parameters IL-1β, IL-6 and TNF-α will be measured IL-1β, IL-6 and TNF-α levels will be measured photometrically with commercially available ELISA kits.
Time frame
Changes Before Treatment and 1 month after treatment4
Oxidative Stress Biomarker analyses
TAS, TOS, TT and NT levels of oxidative stress parameters in blood samples taken from AD patients will be measured. TAS, TOS, TT, NT levels of blood samples taken will be measured by photometric method with kits to be purchased commercially. The oxidative stress index (OSI) will be found as TOS/TAS, and the amount of dynamic disulfide bonds will be found by determining half of the difference between the TT and NT groups.
Time frame
Changes Before Treatment and 1 month after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Istanbul Medipol University Hospital
Lead sponsor
Bezmialem Vakif University
Collaborator
Saglik Bilimleri Universitesi
Collaborator
Source ClinicalTrials.gov