- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01959373
Dysfunctions and Plasticity Mechanisms of Motor System Assessed by Cortico-cortical and Cortico-muscular Coherence Analysis in Amyotrophic Lateral Sclerosis
Amyotrophic lateral sclerosis (ALS) is characterized clinically by abnormalities of both upper motor neurons (UMN) and lower motor neurons (LMN). The presence of UMN signs is not always easy to establish. The only technique used in routine to assess the corticospinal dysfunctions is based on transcranial magnetic stimulation (TMS). However, this technique is largely dependent on LMN state and is based on artificial motor cortex activation.
The main objective of our study project is to evaluate a new method assessing functional changes in motor system in ALS patients. By using cortico-muscular and cortico-cortical coherences, it could be possible to show modifications in both cortico-muscular relationship and in cortical activity coordination which could be related to clinical state in ALS patients. We notably expect a decrease in cortico-muscular coherence in ALS patients. Furthermore, these analyses could provide new insights in motor system plasticity phenomena. We expect a partial covering of voluntary motor command by cortical areas adjacent to primary motor cortex. Lastly, the hypothesis that an increased proportion of voluntary motor control may be assumed by ipsilateral corticospinal tract could be tested by coherence analyses.
Coherence analysis might be a useful method to detect corticospinal tract dysfunctions. This method has the advantage to be painless and not to use artificial stimulations as it is used in TMS.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Marseille, 프랑스, 13354
- Assistance Publique Hopitaux de Marseille
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patient female or male, more than 18 years,
- Patien with a diagnosis of amyotrophic lateral sclerosis according to the El Escorial criteria of Brooks et al. 1994
- Patient , the beginning of the SLA date less than 12 months,
- Patient not having a familial form of ALS,
- Patient not having cancer, autoimmune disease, liver failure, severe hypertension or untreated, severe conduction disorders or uncontrolled arrhythmia
- Patient not having a chronic psychiatric disease, dementia.
- Patient with normal visual function
- Patients receiving social coverage
- Patient have read, understood and signed an informed consent after information
Exclusion Criteria:
- Patient minor
- Patient with a familial form of ALS,
- Patient associated with severe progressive disease (cancer, autoimmune disease , liver failure )
- Patient (s) with chronic mental illness, dementia ,
- Presence of atypical clinical signs such as cerebellar ataxia , extrapyramidal signs, sensory disorders , autonomic dysfunction .
- Clinical signs of chronic respiratory failure or slow and / or forced less than 70% of the theoretical value or chronic hypercapnia than 45 mmHg vital capacity .
- Patient private freedom following a judicial or administrative decision
- Patient major Trust
- Pateinte pregnant, parturient , lactating
- Patient major in legal protection ( guardianship )
- Pateinte pregnant , parturient , lactating
- Patient hospital without consent
- Patient admitted in a health or social establishment for purposes other than research
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 환자
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실험적: 건강한 지원자
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
recording neuronal activities
기간: 12 months
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simultaneous recording of brain activity using electrodes attached to the scalp and muscle activities of muscles of the hands with electrodes bonded to the skin.
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12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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identify plasticity phenomena
기간: 12 months
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identify plasticity phenomena used in the cortex during the disease.
The question is whether a reorganization of cortical networks could preserve, temporarily, the ability of patients to perform muscle contractions which case to determine the nature of the changes induced
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12 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
electroencephalograms (EEG)에 대한 임상 시험
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Radboud University Medical Center완전한
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University of Massachusetts, WorcesterNational Center for Complementary and Integrative Health (NCCIH)완전한
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Centre Hospitalier Universitaire de BesanconPlateforme Neuraxess모병
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Andrea Rossetti, MD완전한
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University Hospital, ToulouseCentre National de la Recherche Scientifique, France모병