- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02148887
Plasticity of Grey and White Matter in Response to Motor Skill Training in Healthy Individuals and Those With Spinal Cord Injury
연구 개요
상세 설명
Functional recovery following human spinal cord injury (SCI) remains frustratingly limited and the majority of patients are left with severe impairments. While rehabilitative training has been shown to improve clinical outcome following SCI and has a major effect on patients' quality of life, the neuronal mechanisms underpinning neurological and functional recovery are not well understood.
Until recently, degenerative changes in components of the CNS remote to a SCI were thought to occur slowly (over years) and correlate with the degree of disability. Using longitudinal MRI protocols we have shown that these structural changes in fact occur early and progress both at the cord and brain level according to a specific spatial and temporal pattern (Freund et al 2013). It is thought that these trauma-induced structural changes progress retrogradely along central motor nerve fibres of the myelinated corticospinal tract (CST) and this is accompanied over time by shrinkage of corticospinal projecting neuronal bodies. Crucially, patients with less atrophy throughout the CST were those with better clinical recovery at twelve months. Despite this significant recovery advantage in some patients, all participants showed irreversible tissue loss, potentially hindering further recovery. Using the neuroimaging biomarkers established in the previous study cited above, we now aim to assess whether specific and intensive motor learning through tasks for the upper and lower limb might slow or reverse the atrophy seen in the sensorimotor system.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
-
Zurich, 스위스, 8008
- Universitätsklinik Balgrist
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
Patients:
- Injury to the spinal cord which leads to any neurological deficits
- able to provide Informed consent
Controls:
- able to provide informed consent
Exclusion Criteria:
- Pregnancy
- MRI incompatible
- Neurologic or physiatric disorders
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
SCI patients with upper limb impairment - Upper limb training
|
|
SCI patients with lower limb impairment - Lower limb training
|
|
Healthy controls - Upper limb training
|
|
Healthy controls - Lower limb training
|
|
Healthy controls - No intervention
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
MRI parameters: tensor based morphometry, longitudinal relaxation rate, magnetisation transfer and diffusion index changes in the cervical and cranial corticospinal tract, basal ganglia, motor, premotor and parietal cortex.
기간: MRI scans at weekly intervals (day 0, 7, 14, 28 and 84 after commencement of training)
|
MRI scans at weekly intervals (day 0, 7, 14, 28 and 84 after commencement of training)
|
|
Raw performance data in the upper and lower limb training task, recorded at each training session.
기간: Training sessions 4x1hour per week for 4 weeks
|
Training sessions 4x1hour per week for 4 weeks
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Overall activity levels as recorded by a worn accelerometer and clinical scoring tests repeated immediately following the first and final training scan sessions (Day 0 and 28) and the 84 day follow-up scan.
기간: Training sessions 4x1hour per week for 4 weeks; clinical assessments at day 0, 28, 84
|
Training sessions 4x1hour per week for 4 weeks; clinical assessments at day 0, 28, 84
|
|
3D gait analysis will be performed on certain patients and control subjects at the first and final training scan sessions (Day 28) and the 84 day follow-up scan
기간: 3D gait analysis at day 0, 28, 84
|
3D gait analysis at day 0, 28, 84
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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. .