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Stability of rTMS on Cognition and Brain Networks on Healthy Subjects.

2016년 4월 18일 업데이트: Qualissima

Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Cognition and Brain Networks in Healthy Subjects in 2 Sessions 15 Days Apart

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.

연구 개요

연구 유형

중재적

등록 (실제)

158

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Barcelona, 스페인, 08036
        • IDIBAPS
      • Marseille, 프랑스, 13005
        • Cic-Cpcet

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

남성

설명

Inclusion Criteria:

  • Healthy male subjects aged between 18 and 40 years-old inclusive.
  • Education level: at least secondary.
  • Right-handed (Edinburgh Handedness Inventory).
  • The subjects are in good health on the basis of the medical interview (medical history, symptoms), the physical examination and vital signs.
  • No history of psychiatric disorders (assessed by Structured Clinical Interview for DSM IV Disorders (SCID) for Barcelona and by the Mini International Neuropsychiatric Interview (MINI) for Marseille).
  • No history of neurological disorders
  • No history of concussion (cranial or facial trauma) without or with loss of consciousness.
  • Subject without history of brain disease (severe brain trauma, stroke, cerebral tumor...).
  • Subject without lesion on MRI.
  • Subject without abnormal electrical activities on standard clinical EEG.
  • No history of drug or alcohol abuse.
  • No smoker or ≤ 5 cg/ day.
  • The subject can complete the neuropsychological test battery during the training session.
  • Subject without contraindication to MRI.
  • 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 has provided written informed consent.

Exclusion Criteria:

  • History or presence of psychiatric illness (Psychiatric interview).
  • History or presence of neurologic illness.
  • 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.
  • Presence of metallic objects within the body.
  • Subjects with pacemaker.
  • Claustrophobia.
  • Individual and familial history of epileptic seizure.
  • Any medication listed (see annexe) in the safety guidelines published by the Safety of TMS Consensus Group (Rossi et al., 2009) will be forbidden.
  • Subject with a correct hit rate during the retrieval session of the memory task

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: ineffective rTMS - Active TBS - fMRI
A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold. Active stimulation will be applied on the L-DLPFC compared to an ineffective stimulation.
A continuous Theta-Burst Stimulation (cTBS) protocol will be applied over the L-DLPFC. Three stimuli at 50Hz, 80% of individual Motor Threshold will be repeated every 200ms for 40sec
Functional MRI data will be acquired during the performance of the memory task. Functional data will be acquired with a blood oxygenation level dependant (BOLD) contrast sensitive gradient echo, T2*-weighted echo-planar imaging sequence
실험적: Effective rTMS - Active TBS - fMRI
A continuous Theta-Burst Stimulation (cTBS) protocol will be applied over the L-DLPFC. Three stimuli at 50Hz, 80% of individual Motor Threshold will be repeated every 200ms for 40sec
Functional MRI data will be acquired during the performance of the memory task. Functional data will be acquired with a blood oxygenation level dependant (BOLD) contrast sensitive gradient echo, T2*-weighted echo-planar imaging sequence
A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold. Active stimulation will be applied on the L-DLPFC compared to an effective stimulation.
가짜 비교기: ineffective rTMS - Sham TBS - fMRI
A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold. Active stimulation will be applied on the L-DLPFC compared to an ineffective stimulation.
Functional MRI data will be acquired during the performance of the memory task. Functional data will be acquired with a blood oxygenation level dependant (BOLD) contrast sensitive gradient echo, T2*-weighted echo-planar imaging sequence
A Sham stimulation will be applied over the L-DLPFC. a placebo coil will be used.
가짜 비교기: Effective rTMS - Sham TBS - fMRI
Functional MRI data will be acquired during the performance of the memory task. Functional data will be acquired with a blood oxygenation level dependant (BOLD) contrast sensitive gradient echo, T2*-weighted echo-planar imaging sequence
A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold. Active stimulation will be applied on the L-DLPFC compared to an effective stimulation.
A Sham stimulation will be applied over the L-DLPFC. a placebo coil will be used.
실험적: ineffective rTMS - Active TBS - EEG
A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold. Active stimulation will be applied on the L-DLPFC compared to an ineffective stimulation.
A continuous Theta-Burst Stimulation (cTBS) protocol will be applied over the L-DLPFC. Three stimuli at 50Hz, 80% of individual Motor Threshold will be repeated every 200ms for 40sec
EEG will be coupled with task performance in an event-related manner to be able to isolate brain activity of each type of stimuli presented. EEG imaging data will be acquired during the memory task.
실험적: Effective rTMS - Active TBS - EEG
A continuous Theta-Burst Stimulation (cTBS) protocol will be applied over the L-DLPFC. Three stimuli at 50Hz, 80% of individual Motor Threshold will be repeated every 200ms for 40sec
A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold. Active stimulation will be applied on the L-DLPFC compared to an effective stimulation.
EEG will be coupled with task performance in an event-related manner to be able to isolate brain activity of each type of stimuli presented. EEG imaging data will be acquired during the memory task.
가짜 비교기: ineffective rTMS - Sham TBS - EEG
A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold. Active stimulation will be applied on the L-DLPFC compared to an ineffective stimulation.
A Sham stimulation will be applied over the L-DLPFC. a placebo coil will be used.
EEG will be coupled with task performance in an event-related manner to be able to isolate brain activity of each type of stimuli presented. EEG imaging data will be acquired during the memory task.
가짜 비교기: Effective rTMS - Sham TBS - EEG
A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold. Active stimulation will be applied on the L-DLPFC compared to an effective stimulation.
A Sham stimulation will be applied over the L-DLPFC. a placebo coil will be used.
EEG will be coupled with task performance in an event-related manner to be able to isolate brain activity of each type of stimuli presented. EEG imaging data will be acquired during the memory task.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Outputs of the memory task
기간: up to Day 15
outputs: number of correct answers during the retrieval event-related task (Hit rate) and the rate of false recognition of novel pictures (False Alarms rate).
up to Day 15

2차 결과 측정

결과 측정
측정값 설명
기간
CANTAB task
기간: Day 1 and Day 15
  • CANTAB / Rapid Visual Information Processing (RVIP)
  • CANTAB / Spatial Working Memory (SWM)
  • CANTAB / Paired Associates Learning (PAL)
Day 1 and Day 15
Gene expression
기간: Day 1
Interest genes expression will be investigated depending on the impact of TMS on behavioral and functional brain responses.
Day 1
Imaging
기간: Day1 and Day 15

Functional MRI (Barcelona): modifications will be highlighted by changes in Blood Oxydation level Dependence (BOLD)signal patterns

EEG (Marseille): modifications will be highlighted by changes in EEG markers

Day1 and Day 15

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Christine Audebert, Cic-Cpcet

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2013년 5월 1일

기본 완료 (실제)

2015년 12월 1일

연구 완료 (실제)

2015년 12월 1일

연구 등록 날짜

최초 제출

2013년 5월 16일

QC 기준을 충족하는 최초 제출

2013년 5월 22일

처음 게시됨 (추정)

2013년 5월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 4월 19일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 4월 18일

마지막으로 확인됨

2016년 4월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • WP1P003

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

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미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

ineffective rTMS에 대한 임상 시험

3
구독하다