kTMP-Enhanced Motor Rehabilitation for Chronic Stroke Recovery (KULMINATE) Pilot
kTMP-Enhanced Motor Rehabilitation for Chronic Stroke Recovery
연구 개요
상세 설명
The goal of this pilot clinical trial is to assess the feasibility and preliminary efficacy of kTMP on upper limb motor recovery in chronic stroke compared to sham. We will conduct a 6-week double-blind, randomized, sham-controlled pilot study to test the beneficial influence of kTMP combined with simple motor tasks on kinematic outcomes such as range of motion of the upper arm, hand and fingers.
After baseline assessments, participants will be randomly allocated to either the kTMP group or the Control group. Participants, experimentalists, and outcome assessors will be blinded to group allocation. kTMP will begin within 1 week following randomization and will be delivered three times a week for 6 weeks. The primary endpoint will be assessed at the end of treatment, with follow-up assessments occurring 1 month, 3 months and 6 months following treatment completion. There is one assessment 4 weeks into the treatment phase to assess if patients continue to improve from 4 to 6 weeks of treatment.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ludovica Labruna, PhD
- 전화번호: 5104237125
- 이메일: participate@magnetictides.com
연구 장소
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California
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San Francisco, California, 미국, 94158
- 모병
- UCSF Mission Bay- Sandler Neurosciences Center
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연락하다:
- Christina Merrick
- 전화번호: 510-423-7125
- 이메일: participate@magnetictides.com
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수석 연구원:
- Ludovica Labruna, PhD
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수석 연구원:
- Richard Ivry, PhD
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수석 연구원:
- Karunesh Ganguly, MD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion criteria:
- Adults aged 18-80 years who have a history of an ischemic or hemorrhagic stroke ≥ 12 m prior to enrollment.
- Fugl-Meyer Assessment: Upper Extremity (FMA UE) score 20-50.
- Ability to communicate, understand, and give appropriate consent. Participants can follow two-step commands.
- Motor evoked potentials in a hand muscle when stimulating ipsilesional cortex with suprathreshold single-pulse TMS (MEP positive).
Exclusion criteria:
- Participants with moderate or severe cognitive impairment (MoCA < 18).
- Participants with sensory deficits FMA-S < 6/12 (with proprioception < 4/8).
- Participants with severe apraxia (TULIA < 5).
- Language impairment or behavioral disorder that interferes with their ability to adhere to the protocol or to provide informed consent.
- Individuals who have a serious uncontrolled medical condition, including but not limited to severe cardiovascular and cardiopulmonary disease.
- Pregnancy or plans to become pregnant during the study period.
- Botulinum toxin injections of the affected upper extremity within 3 months prior to onset of study.
- Severe spasticity of the affected upper limb (Modified Ashworth ≥ 4).
- Absolute contraindications related to non-invasive brain stimulation, including:
9a) History of seizures in the last 12 months while taking anti-epilepsy medication 9b) Presence of any metal implants in the head (excluding the mouth), such as cortical stimulators and DBS, clips, coils, shunts, stents or skull plates, cochlear implants 9c) Permanent eye liner or head tattoos 9d) Implanted electronics such as pacemakers, defibrillators, intrathecal baclofen pumps or vagus nerve stimulator 9e) History of experiencing a serious adverse event during a previous transcranial magnetic stimulation (TMS) session
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 활성 KTMP
참가자들은 8V/m의 활성 자극을 받았습니다
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새로운 비침습적 뇌 자극 도구
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가짜 비교기: Sham kTMP
Participants receive sham stimulation (0.0 V/m electric field)
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가짜 설정이 선택된 새로운 비침습적 뇌 자극 도구
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Range of Joint Motion (ROM)
기간: 6 weeks
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defined as the standard deviation of the joint angle time series for a given trial.
The median ROM will be calculated for eleven degrees of freedom and then averaged.
If there are joints which appear to be compensatory, they will be removed from the analysis
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6 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Fugl- Meyer Assessment (Upper Extremity)
기간: 6 weeks
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A comprehensive clinical examination that has been widely used to evaluate stroke-related motor impairment.
It is graded from 0 (hemiplegia) to 66 for the Upper extremity.
Higher scores signifies better motor control, and hence a better outcome.
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6 weeks
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Modified Ashworth Scale (MAS)
기간: 6 weeks
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Used to measure spasticity in wrist and hand flexors and extensors.
It assigns a grade of spasticity from 0-4.
Lower scores represent normal muscle tone and higher scores represent spasticity.
Hence lower scores are associated with better outcomes.
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6 weeks
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Transport Time
기간: 6 weeks
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Calculated for each of three epochs, pre, during and post
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6 weeks
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Trial to Trial Variability (T2TV)
기간: 6 weeks
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Defined as the mean-squared error between the joint angle time-series for a given trial and the median joint angle timeseries.
The median T2TV will be calculated for eleven degrees of freedom.
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6 weeks
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Grasp to Lift Time
기간: 6 weeks
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Calculated for each of three epochs, pre, during and post
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6 weeks
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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 연구와 관련된 용어
키워드
기타 연구 ID 번호
- kTMPstrokePilot
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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