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临床试验/NCT05977088
NCT05977088招募中不适用

Prediction of Cognitive, Neurotrophic, Anti-Inflammatory, and Antioxidant Effectiveness of rTMS Application in Alzheimer's Patients

Istanbul Medipol University Hospital2 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2022年2月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
2
主要终点
The Mini Mental State Examination

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

The Mini Mental State Examination

时间窗: Changes Before Treatment and 1 month after treatment

Cognitive Neuropsychological Test Score

Neuropsychiatric Inventory

时间窗: Changes Before Treatment and 1 month after treatment

Cognitive Neuropsychological Test Score

Geriatric Depression Scale

时间窗: Changes Before Treatment and 1 month after treatment

Cognitive Neuropsychological Test Score

ADSL

时间窗: Changes Before Treatment and 1 month after treatment

Cognitive Neuropsychological Test Score

Alzheimer's Disease Assessment Scale

时间窗: Changes Before Treatment and 1 month after treatment

Cognitive Neuropsychological Test Score

次要结局

  • Blood samples ELISA analyses(Changes Before Treatment and 1 month after treatment)
  • Evaluation of Fatty Acid Profile Analysis with GC-MS(Changes Before Treatment and 1 month after treatment)
  • Metabolomics Analysis by Liquid Chromatography-Mass Spectrometer/Mass Spectrometer (LC-MS/MS)(Changes Before Treatment and 1 month after treatment)
  • EEG Power Spectrum Analysis(Changes Before Treatment and 1 month after treatment)
  • Inflammatory Biomarker analyses(Changes Before Treatment and 1 month after treatment)
  • EEG Coherence Analysis(Changes Before Treatment and 1 month after treatment)
  • Blood samples analyses(Changes Before Treatment and 1 month after treatment)
  • Oxidative Stress Biomarker analyses(Changes Before Treatment and 1 month after treatment)

研究者

发起方
Istanbul Medipol University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Lutfu Hanoglu, MD

Prof Dr MD

Istanbul Medipol University Hospital

研究点 (2)

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