- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04811066
Motor Learning and Multi-session tDCS in Parkinson's Disease
The Effect of Multi-session Transcranial Direct Current Stimulation Applied Over the Primary Motor Cortex on Motor Sequence Learning in Parkinson's Disease
연구 개요
상세 설명
Parkinson's disease is characterised by deficits of motor control triggered by impaired basal ganglia function, such as bradykinesia and tremor. Beyond the visibly recognisable motor symptoms of Parkinson's disease, the ability to learn a sequence of movements is also compromised and poses a significant barrier to effective rehabilitation. In healthy individuals, transcranial direct current stimulation applied over the primary motor cortex during motor task practice has been shown to significantly improve motor learning compared to placebo conditions.
The present study seeks to examine the effect of multi-session transcranial direct current stimulation applied over the primary motor cortex in people with Parkinson's disease on sequential motor learning performance. Participants will be required to attend eight laboratory sessions, comprising five intervention and three assessment sessions and will be tested on their ability to learn a 16-digit finger tapping sequence with their right hand. Sessions one to five will form the intervention and will be performed at the same time on consecutive days (i.e. mon-fri). In addition, session one will double as a baseline assessment and intervention session. Assessments sessions will be performed once before the intervention (session one), and three times following the intervention on day three, one week, and four weeks post intervention.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Hung Hom
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Hong Kong, Hung Hom, 홍콩
- The Hong Kong Polytechnic University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Right-handed (Edinburgh Handedness Inventory; ≥50)
- Cognitively capable (Montreal Cognitive Assessment (MoCA); ≥23)
- Mild to moderate Parkinson's disease severity (Hoehn and Yar disease stage 2-3)
- On stable dopaminergic medication
Exclusion Criteria:
- History of stroke
- Comorbidity
- Cephalic implants
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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가짜 비교기: Sham tDCS
Anodal electrode (35 cm2 sponge electrode) placed over C3.
Cathodal electrode (35 cm2 sponge electrode) placed over the right supraorbital area.
Stimulation was phased in for 30 seconds up to 2 mA and then switched off.
Stimulation was again phased in for 30 seconds following 20 minutes of no stimulation.
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Transcranial electrical stimulation device. A weak direct electrical current, up to 2 mA, is passed between two electrodes placed on the scalp. Electrodes are housed in 35 cm2 sponges saturated with 4 ml of saline solution (0.9 % NaCl) per side, per pad. Stimulation is phased in with a 30-second ramp up of the electrical current to the specified stimulation parameters. Following the specified stimulation period, the current is phased-out with a ramp down of the current. For sham stimulation, the ramp-up and ramp-down periods are retained, but stimulation is switched off during the specified stimulation period.
다른 이름들:
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실험적: Anodal tDCS
Anodal electrode (35 cm2 sponge electrode) placed over C3.
Cathodal electrode (35 cm2 sponge electrode) placed over the right supraorbital area.
20 minutes of stimulation at 2 mA with a 30-second phase-in and phase-out period.
|
Transcranial electrical stimulation device. A weak direct electrical current, up to 2 mA, is passed between two electrodes placed on the scalp. Electrodes are housed in 35 cm2 sponges saturated with 4 ml of saline solution (0.9 % NaCl) per side, per pad. Stimulation is phased in with a 30-second ramp up of the electrical current to the specified stimulation parameters. Following the specified stimulation period, the current is phased-out with a ramp down of the current. For sham stimulation, the ramp-up and ramp-down periods are retained, but stimulation is switched off during the specified stimulation period.
다른 이름들:
|
|
실험적: Cathodal tDCS
Cathodal electrode (35 cm2 sponge electrode) placed over C3.
Anodal electrode (35 cm2 sponge electrode) placed over the right supraorbital area.
20 minutes of stimulation at 2 mA with a 30-second phase-in and phase-out period.
|
Transcranial electrical stimulation device. A weak direct electrical current, up to 2 mA, is passed between two electrodes placed on the scalp. Electrodes are housed in 35 cm2 sponges saturated with 4 ml of saline solution (0.9 % NaCl) per side, per pad. Stimulation is phased in with a 30-second ramp up of the electrical current to the specified stimulation parameters. Following the specified stimulation period, the current is phased-out with a ramp down of the current. For sham stimulation, the ramp-up and ramp-down periods are retained, but stimulation is switched off during the specified stimulation period.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline: sequential finger tapping performance
기간: Four assessments: Baseline (pre-intervention), 3 days, 1 week, and 4 weeks post intervention. Performance is also assessed during the intervention period on each day the intervention is applied. Once immediately before and after intervention is applied.
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A skill index reflecting the accuracy and speed that participants perform a specified finger tapping sequence.
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Four assessments: Baseline (pre-intervention), 3 days, 1 week, and 4 weeks post intervention. Performance is also assessed during the intervention period on each day the intervention is applied. Once immediately before and after intervention is applied.
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Change from baseline: shape-counting error
기간: Four assessments: Baseline (pre-intervention), 3 days, 1 week, and 4 weeks post intervention. Performance is also assessed during the intervention period on each day the intervention is applied. Once immediately before and after intervention is applied.
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The percentage of shape counting error during dual task assessments.
Sequential finger tapping + visual shape counting task.
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Four assessments: Baseline (pre-intervention), 3 days, 1 week, and 4 weeks post intervention. Performance is also assessed during the intervention period on each day the intervention is applied. Once immediately before and after intervention is applied.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline: oxygenated haemoglobin response
기간: Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention
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Task related changes of oxygenated haemoglobin as measured using functional near-infrared spectroscopy.
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Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention
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Change from baseline: Movement Disorders Society Unified Parkinson's Disease Rating Scale Motor Section (Part 3)
기간: Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention
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Participants physical function is assessed according to the criteria of the Movement Disorders Society Unified Parkinson's Disease Rating Scale Motor Section (Part 3).
Minimum value = 0, maximum value = 132.
Lower scores indicate a better outcome.
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Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention
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Change from baseline: upper limb motor task performance
기간: Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention
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Timed sequential movement of the arm and hand.
The participant sits upright on a chair that has no arm support with their arms relaxed by their side.
The time taken to perform the following sequence 10 times is recorded: 1. Close and open hand, 2) flex elbow, 3) close and open hand, 4) extend elbow.
Right and left arms are assessed separately.
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Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention
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Change from baseline: Purdue pegboard task performance
기간: Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention
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Participants are required to pick up a metal peg and place the peg in a specified row of holes.
Pegs must be placed one at a time.
The maximum number of pegs placed within 30 seconds is recorded.
The assessment is repeated three times for each hand.
Each hand is assessed separately.
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Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention
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공동 작업자 및 조사자
수사관
- 수석 연구원: Margaret Mak, Dr, The Hong Kong Polytechnic University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
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. .
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Nandakumar NarayananNational Institute of Neurological Disorders and Stroke (NINDS)초대로 등록
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University of PennsylvaniaEUSA Pharma, Inc.; Castleman Disease Collaborative Network모병캐슬맨병 | 캐슬맨병 | 거대 림프절 과형성 | 혈관여포 림프 증식증 | 혈관여포 림프절 과형성 | 혈관여포성 림프종 과형성 | GLNH | 과형성, 거대 림프절 | 림프절 과형성, 거인미국
Transcranial direct current stimulation에 대한 임상 시험
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University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)완전한
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Hospital Center Guillaume Régnier모병
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Stanford UniversityNYU Langone Health; Wills Eye; Otto-von-Guericke University Magdeburg모집하지 않고 적극적으로