Prediction of Effectiveness of rTMS Application in Alzheimer's Patients
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Repetetive Transcranial Magnetic Stimulation.
- Кому может быть актуально
- Состояния в реестре: Alzheimer Disease. Базовые параметры: от 55 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Turkey (Türkiye)
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Prediction of Cognitive, Neurotrophic, Anti-Inflammatory, and Antioxidant Effectiveness of rTMS Application in Alzheimer's Patients
Обзор
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.
Подробное описание
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.
Вмешательства
- Устройство 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.
Первичные конечные точки
- The Mini Mental State Examination [Срок оценки: Changes Before Treatment and 1 month after treatment]
- Neuropsychiatric Inventory [Срок оценки: Changes Before Treatment and 1 month after treatment]
- Alzheimer's Disease Assessment Scale [Срок оценки: Changes Before Treatment and 1 month after treatment]
- ADSL [Срок оценки: Changes Before Treatment and 1 month after treatment]
- Geriatric Depression Scale [Срок оценки: Changes Before Treatment and 1 month after treatment]
Вторичные конечные точки (8)
- Blood samples ELISA analyses [Срок оценки: Changes Before Treatment and 1 month after treatment]
- Blood samples analyses [Срок оценки: Changes Before Treatment and 1 month after treatment]
- Inflammatory Biomarker analyses [Срок оценки: Changes Before Treatment and 1 month after treatment]
- Oxidative Stress Biomarker analyses [Срок оценки: Changes Before Treatment and 1 month after treatment]
- Evaluation of Fatty Acid Profile Analysis with GC-MS [Срок оценки: Changes Before Treatment and 1 month after treatment]
- Metabolomics Analysis by Liquid Chromatography-Mass Spectrometer/Mass Spectrometer (LC-MS/MS) [Срок оценки: Changes Before Treatment and 1 month after treatment]
- EEG Power Spectrum Analysis [Срок оценки: Changes Before Treatment and 1 month after treatment]
- EEG Coherence Analysis [Срок оценки: Changes Before Treatment and 1 month after treatment]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Turkey (Türkiye) · 1 центр
- Medipol University Hospital — Istanbul
Идентификаторы
NCT: NCT05977088 · 221S749