Impact of VNS With Rehab on Gait Post-Stroke
The Impact of Vagus Nerve Stimulation Paired With Rehabilitation on Lower Limb and Gait Functions After Ischemic Stroke
연구 개요
상세 설명
Stroke is a major cause of disability worldwide and currently there is a lack of effective treatments to improve functional capacity of patients with long-term disability. Vagus Nerve Stimulation (VNS) is FDA-approved for rehabilitation of upper limb deficits in patient with stroke. The device (including Vagus nerve electrodes and chest generator) is permanently implanted prior to the beginning of rehabilitation as standard of care. It is activated by patients and physical therapists during a period of 4.5 months of in-clinic and home therapy. However, so far there have been no approved neuromodulation treatments to improve lower limb functions and gait, which are key for patients' quality of life and their ability to integrate with work and social cycles.
This project will evaluate the impact of VNS on lower limb functions as measured by clinical and laboratory-based analyses of gait in stroke survivors. Patients with both upper and lower limb deficits will be included in this project. After the completion of the standard upper limb VNS-rehabilitation protocol, patients will be double-blindly randomized into 2 groups: a) lower limbs and gait rehabilitation with VNS ON for the duration of therapy; b) lower limbs and gait rehabilitation with VNS OFF.
Based on prior experience with upper limb deficits, we hypothesize that rehabilitation therapy coupled with VNS neuromodulation will elicit functional improvements in lower limb deficits and gait.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ellen M Carl, PhD, CCRP
- 전화번호: 7260 716-218-1000
- 이메일: ecarl@ubns.com
연구 연락처 백업
- 이름: Amylynn M Liskiewicz, MA, CCRP
- 전화번호: 716-218-1000
- 이메일: aliskiewicz@ubns.com
연구 장소
-
-
New York
-
Buffalo, New York, 미국, 14203
- 모병
- University at Buffalo Neurosurgery
-
연락하다:
- Ellen M Carl, PhD, CCRP
- 전화번호: 7260 716-218-1000
- 이메일: ecarl@ubns.com
-
연락하다:
- Amylynn M Liskiewicz, MA, CCRP
- 전화번호: 716-218-1000
- 이메일: aliskiewicz@ubns.com
-
수석 연구원:
- Assaf Berger, MD
-
부수사관:
- Jonathan Riley, MD
-
부수사관:
- Sue Ann Sisto, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Approved for Vagus Nerve Stimulation (VNS) and rehabilitation therapy
- ≥22 years and ≤ 80 years
- Only patients who elect to undergo VNS therapy for stroke-related upper limb deficits
- Residual active movement in the affected limb's thumb and other 2 fingers
- Stroke-related deficits in the lower limbs and gait with a Functional Ambulation Category (FAC) ≥3
- Able to follow simple instructions and independently walk short distances with or without external support or leg orthoses, but without manual contact with another person
Exclusion Criteria:
- Intact lower limb functions (Fugl-Meyer score=34)
- Not a candidate for VNS therapy according to FDA guidelines
- Pregnant patients
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: VNS ON
Receives active stimulation during therapy
|
Implanted vagus nerve stimulation (VNS) therapy for post-stroke recovery (Vivistim System, MicroTransponder, Austin, TX, USA)
|
|
가짜 비교기: VNS OFF
No stimulation during therapy
|
Implanted vagus nerve stimulation (VNS) therapy for post-stroke recovery (Vivistim System, MicroTransponder, Austin, TX, USA)
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Absolute Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale
기간: 90 days post-operation
|
Absolute change in FMA-LE from baseline to 90 days
|
90 days post-operation
|
|
Percent Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale
기간: 90 days post-operation
|
Percent change in FMA-LE from baseline to 90 days
|
90 days post-operation
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Absolute Change in Functional Assessment - 10-meter walk
기간: 90 days post-operation
|
Absolute change in gait function as assessed by the timed 10-meter walk from baseline to 90 days
|
90 days post-operation
|
|
Percent Change in Functional Assessment - 10-meter walk
기간: 90 days post-operation
|
Percent change in gait function as assessed by the timed 10-meter walk from baseline to 90 days
|
90 days post-operation
|
|
Absolute Change in Functional Assessment - 6-minute walk
기간: 90 days post-operation
|
Absolute change in gait function as assessed by the 6-minute walk from baseline to 90 days
|
90 days post-operation
|
|
Percent Change in Functional Assessment - 6-minute walk
기간: 90 days post-operation
|
Percent change in gait function as assessed by the 6-minute walk from baseline to 90 days
|
90 days post-operation
|
|
Absolute Change in Functional Assessment - Berg Balance Scale
기간: 90 days post-operation
|
Absolute change in gait function as assessed by the Berg Balance Scale from baseline to 90 days
|
90 days post-operation
|
|
Percent Change in Functional Assessment - Berg Balance Scale
기간: 90 days post-operation
|
Percent change in gait function as assessed by the Berg Balance Scale from baseline to 90 days
|
90 days post-operation
|
|
Absolute Change in Functional Assessment - Five Times Sit-to-Stand Test
기간: 90 days post-operation
|
Absolute change in gait function as assessed by the Five Times Sit-to-Stand test from baseline to 90 days
|
90 days post-operation
|
|
Percent Change in Functional Assessment - Five Times Sit-to-Stand Test
기간: 90 days post-operation
|
Percent change in gait function as assessed by the Five Times Sit-to-Stand test from baseline to 90 days
|
90 days post-operation
|
|
Absolute Change in Functional Assessment - Stroke Impact Scale
기간: 90 days post-operation
|
Absolute change in gait function as assessed by the Stroke Impact Scale from baseline to 90 days
|
90 days post-operation
|
|
Percent Change in Functional Assessment - Stroke Impact Scale
기간: 90 days post-operation
|
Percent change in gait function as assessed by the Stroke Impact Scale from baseline to 90 days
|
90 days post-operation
|
|
Absolute Change in Functional Assessment - 3D Motion Analysis of Gait
기간: 90 days post-operation
|
Absolute change in gait function as assessed by the 3D Motion Analysis of Gait from baseline to 90 days
|
90 days post-operation
|
|
Percent Change in Functional Assessment - 3D Motion Analysis of Gait
기간: 90 days post-operation
|
Percent change in gait function as assessed by the 3D Motion Analysis of Gait from baseline to 90 days
|
90 days post-operation
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Assaf Berger, MD, University at Buffalo
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
기타 연구 ID 번호
- STUDY00008984
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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. .
뇌졸중에 대한 임상 시험
-
Institut National de la Santé Et de la Recherche...모병
Vagus Nerve Stimulation Therapy에 대한 임상 시험
-
University of Malaga아직 모집하지 않음스트레스 | 불명증 | 수면 장애