Prediction of Effectiveness of rTMS Application in Alzheimer's Patients
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Repetetive Transcranial Magnetic Stimulation.
- Who it may be relevant to
- Registry conditions: Alzheimer Disease. Basic parameters: from 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prediction of Cognitive, Neurotrophic, Anti-Inflammatory, and Antioxidant Effectiveness of rTMS Application in Alzheimer's Patients
Overview
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.
Detailed description
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. This study aim is to predict the benefit rate to be obtained from the treatment by using various evaluation parameters before starting rTMS treatment. 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.
In our project, 20 people will be included in the study and control groups and electroencephalography (EEG) and TMS will be used together in the study. Before rTMS treatment, resting EEG data will be taken for 5 minutes, eyes open and closed. At the end of all these procedures, rTMS treatment will be started, which will take 5 days. The treatment will consist of two sessions per day with a 20 Hz stimulating protocol, 1500 beats to right-left DLPFC, and totaly 3000 beats. EEG recordings will be taken again from all patients one week after the treatment.
Changes in the cognitive functions of Alzheimer's patients will be made through the neuropsychometric test battery taken before and after rTMS. With the analysis of neuropsychometric data, the study group will be divided into two subgroups that benefit from TMS and those who do not. In addition, EEG data obtained before and after-TMS will be compared with power spectrum, coherence, functional connectivity and graph methods in both the study and control groups, and information about the electrophysiological effects of TMS will be obtained.
Blood samples of the patients before and after rTMS will be taken and the changes in the metabolites given below will be compared: Brain Derived Neurotrophic Factor, Glial Based Neurotrophic Factor, Total Oxidant Level, Total Antioxidant Level, Oxidative Stress Index, Total Thiol, Native Thiol, Disulfide, Exosome, Inflammation Biomarkers (interleukin 1 Beta, interleukin 6, Tumor Necrosis Alpha, Interferon gamma, Nuclear factor kappa ß), Albumin Globulin ratio, Omega 6 and Omega 3. Thus, rTMS has possible neuroprotective, anti-inflammatory and antioxidant effects, consequently modifying the disease process. Additional information will be obtained about.
Interventions
- Device Repetetive Transcranial Magnetic Stimulation
.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.
Primary outcome measures
- The Mini Mental State Examination [Time frame: Changes Before Treatment and 1 month after treatment]
- Neuropsychiatric Inventory [Time frame: Changes Before Treatment and 1 month after treatment]
- Alzheimer's Disease Assessment Scale [Time frame: Changes Before Treatment and 1 month after treatment]
- ADSL [Time frame: Changes Before Treatment and 1 month after treatment]
- Geriatric Depression Scale [Time frame: Changes Before Treatment and 1 month after treatment]
Secondary outcome measures (8)
- Blood samples ELISA analyses [Time frame: Changes Before Treatment and 1 month after treatment]
- Blood samples analyses [Time frame: Changes Before Treatment and 1 month after treatment]
- Inflammatory Biomarker analyses [Time frame: Changes Before Treatment and 1 month after treatment]
- Oxidative Stress Biomarker analyses [Time frame: Changes Before Treatment and 1 month after treatment]
- Evaluation of Fatty Acid Profile Analysis with GC-MS [Time frame: Changes Before Treatment and 1 month after treatment]
- Metabolomics Analysis by Liquid Chromatography-Mass Spectrometer/Mass Spectrometer (LC-MS/MS) [Time frame: Changes Before Treatment and 1 month after treatment]
- EEG Power Spectrum Analysis [Time frame: Changes Before Treatment and 1 month after treatment]
- EEG Coherence Analysis [Time frame: Changes Before Treatment and 1 month after treatment]
Eligibility criteria
Inclusion criteria
- 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
- Volunteer to participate in the study
Exclusion criteria
- 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
- Presence of a metal implant on the head or having a pacemaker and contraindications for other TMS applications During the study or 1 month before, having/been receiving/receiving an investigational drug targeting Alzheimer's disease or neuromodulation treatment such as tDCS and TMS, other than standard treatment for AD symptom control such as acetylcholine esterase and memantine, with the potential to affect the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Medipol University Hospital — Istanbul
Identifiers
NCT: NCT05977088 · 221S749