Influence of Repetitive Transcranial Magnetic Stimulation (rTMS) Challenge on Cognitive and Functional Magnetic Resonance Imaging Markers in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Qualissima
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Part A: Location of cerebral activities
研究概览
简要总结
Episodic and working memory processes are the most affected cognitive domains in Alzheimer's Disease (AD) and its early stage, Mild Cognitive Impairment (MCI). Transcranial Magnetic Stimulation (TMS) is a unique tool to interfere with cognitive processes by inducing "virtual and transient lesions", mimicking those observed in MCI. It has proven repeatedly its capacity to interfere with encoding-retrieval memory task. However, to date, only few imaging data exist on the cerebral pathways involved in encoding memory task. Moreover, the stability of TMS effects over time remains to be investigated. If proven to be a stable interfering challenge, TMS could be used to investigate the potential restoring effect of new medication in AD.
The study is the pilot study of a larger clinical trial which aims to prove the utility of rTMS as a potential model for prediction of clinical efficacy using a combination of cognitive and neuroimaging endpoints.
详细描述
Episodic and working memory processes are the most affected cognitive domains in Alzheimer's Disease (AD) and its early stage, Mild Cognitive Impairment (MCI). Transcranial Magnetic Stimulation (TMS) is a unique tool to interfere with cognitive processes by inducing "virtual and transient lesions", mimicking those observed in MCI. It has proven repeatedly its capacity to interfere with encoding-retrieval memory task. However, to date, only few imaging data exist on the cerebral pathways involved in encoding memory task. Moreover, the stability of TMS effects over time remains to be investigated. If proven to be a stable interfering challenge, TMS could be used to investigate the potential restoring effect of new medication in AD.
The study is the pilot study of a larger clinical trial which aims to prove the utility of rTMS as a potential model for prediction of clinical efficacy using a combination of cognitive and neuroimaging endpoints.
This pilot study specifically aims:
- to determine the cerebral region to stimulate using functional neuronavigation,
- to evaluate the effects of rTMS on behavioral and functional imaging data (functional Magnetic Resonance Imaging, fMRI)
- to investigate the stability of the TMS interfering effects by replicating the experimental day up to 4 times.
The study is composed of two parts:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects aged between 18 and 40 years-old inclusive.
- •BMI between 18 kg/m2 to 29 kg/m
- •Education level: at least secondary.
- •Right-handed (Edinburgh Handedness Inventory).
- •Health status
- •The subjects is in good health on the basis of the medical interview (medical history, symptoms) and the physical examination, vital signs.
- •No history of psychiatric or neurological disorders as assessed by Structured Clinical Interview for DSM IV Disorders (SCID).
- •No history of concussion with loss of consciousness more than 20 min.
- •No history of drug or alcohol abuse.
- •Specific to the study
- •The subject can complete the neuropsychological test battery during the training session.
- •Regulations
- •The subject is able to read and understand the Information Form and comply with the protocol instructions and restrictions
- •The subject is covered by a social insurance
- •The subject have provided written informed consent
排除标准
- •Medical history and clinical status
- •History or presence of psychiatric illness (Psychiatric interview).
- •History or presence of neurologic illness.
- •General conditions
- •The subject, in the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any other reason.
- •The subject participates in another clinical trial or is still being within a washout period of 1 month since last taking of a previous clinical trial, or subjects who have received more than 4500 Euros in the previous 12 months for participating in clinical trials.
- •Specific to the study
- •Presence of metallic objects within the head.
- •Subjects with pacemaker.
- •Claustrophobia.
- •Individual and familial history of seizure.
- •Any medication listed in the safety guidelines published by the Safety of TMS Consensus Group (Rossi et al., 2009) will be forbidden.
结局指标
主要结局
Part A: Location of cerebral activities
时间窗: Day 1
Primary endpoints: The location of cerebral activities elicited by the retrieval session of the episodic memory task during fMRI will be the primary endpoint of PART A. PART A will assess task-elicited BOLD signal modifications and determine the target location coordinates and verify the stability of the BOLD signal responses over time and the stability of the target location
Part B: Outputs of the memory task
时间窗: Change between Day 2 and Day 1
Outputs: the number of correct answers during the retrieval blocks (Hit rates)and the number of false recognition of novel pictures (False Alarms rate).
次要结局
- Part A: The outputs of the memory task(Day 1 and Day 2)
- Part B: Imaging and CANTAB tasks(Day 1, 2, 3 and 4)