Closed-Loop Vagus Nerve Stimulation (CLV) for Recovery of Gait After Spinal Cord Injury (SCI)
2026년 7월 23일 업데이트: Dr. Seth Hays, The University of Texas at Dallas
Early Feasibility Study of the ReWire System for Closed-Loop Vagus Nerve Stimulation (CLV) Paired With Rehabilitation After Spinal Cord Injury (SCI) - Lower Limb Study
The purpose of this study is to evaluate the safety, feasibility, and preliminary effectiveness of the ReWire system, which delivers vagus nerve stimulation (VNS) paired with lower limb rehabilitation to improve gait in individuals with mobility impairments resulting from chronic, incomplete spinal cord injury (SCI).
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
상세 설명
A randomized, multi-center, double-blinded sham-control early feasibility trial of participants implanted with the ReWire System for spinal cord injury (SCI) with and open label extension.
During the pre-therapy phase, participants will undergo informed consent, baseline assessment, pre-operative evaluation, surgical implantation of the ReWire system, post-surgical assessment, and randomization. Following post-surgical assessment, participants will be block randomized in a 1:1 ratio to either active CLV (Immediate start group) or sham stimulation (Delayed start group) for the double-blind phase.
In double-blind phase, participants will complete up to 18 sessions of lower limb rehabilitation paired with CLV (Immediate start group) or sham stimulation (Delayed start group). Participants will then undergo assessment after completion of all sessions.
In open-label phase, all participants will receive up to an additional 18 sessions of CLV, regardless of their assignment in the double-blind phase. Participants will then undergo assessment after completion of all sessions.
A final, follow-up assessment will be conducted approximately 4 weeks (a month) from the previous assessment and cessation of CLV.
Long-term assessment of safety will be performed twice annually for up to 2 years from the date of implantation, following the completion of final assessment.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
20
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Amy Porter
- 전화번호: 972-883-7256
- 이메일: alp160730@utdallas.edu
연구 장소
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02129
- Spaulding Rehabilitation Hospital, Mass General Brigham
-
수석 연구원:
- Chad Swank, PhD
-
연락하다:
- Jenny Zhang
- 전화번호: 617-952-6354
- 이메일: jzhang71@mgb.org
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-
Texas
-
Dallas, Texas, 미국, 75246
- Baylor University Medical Center (BUMC)
-
연락하다:
- Niroj Ari
- 전화번호: 214-820-2821
- 이메일: niroj.ari@bswhealth.org
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수석 연구원:
- Rita Hamilton, DO
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Dallas, Texas, 미국, 75204
- Urgent Surgery Associates, PA
-
수석 연구원:
- Michael Foreman, MD
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연락하다:
- Madeline Miller
- 전화번호: 214-821-1599
- 이메일: mwade@urgentsurgery.com
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Richardson, Texas, 미국, 75080
- Texas Biomedical Device Center
-
연락하다:
- Amy Porter
- 전화번호: 972-883-7256
- 이메일: alp160730@utdallas.edu
-
수석 연구원:
- Robert Rennaker, PhD
-
수석 연구원:
- Jane Wigginton, MD
-
연락하다:
- Alvaro Carrera
- 전화번호: 972-883-5397
- 이메일: alvaro.carrera@utdallas.edu
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Ability to provide signed and dated informed consent.
- Willingness and ability to comply with all study procedures and protocol requirements for the duration of the study.
- Age 18 to 64 years.
- Chronic, non-penetrating, motor incomplete spinal cord injury [Association Impairment Scale (AIS) grade C or D] occurring ≥12 months prior to enrollment, resulting in impairment in lower limb function.
- Ambulatory with residual gait impairment attributable to spinal cord injury.
- Self-selected gait speed of < 0.8 m/s as measured by the 10 meter walk test.
- Score of 2 or less on at least 4 measures on the Ambulation subsection of the SCI-Functional Independence scale (SCI-FIS).
- In otherwise good general health as determined by medical history and physical examination.
- Meets all clinical criteria for VNS implantation as determined by the Site PI and clinical care team.
Exclusion Criteria:
- Any history of spinal cord injuries by penetrating traumatic, non-traumatic or congenital causes.
- Evidence of right-sided recurrent laryngeal nerve injury on pre-operative laryngoscopy, if required (Note: Participants with a history of right-sided anterior cervical surgery must undergo laryngoscopy prior to surgical scheduling. A finding of right-sided recurrent laryngeal nerve injury results in exclusion).
- Excessive scar tissue on intraoperative assessment that precludes safe implantation (Note: Participants with a history of left-sided anterior cervical surgery will undergo intraoperative assessment of scar tissue. If excessive scar tissue is deemed to preclude safe implantation, the procedure will be abandoned and the participant excluded for safety reasons. A history of left-sided anterior cervical surgery or prior recurrent laryngeal nerve injury alone does not result in exclusion).
- Concomitant clinically significant brain injuries.
- Deficits in language or attention that interfere with study participation.
- Presence of any other implanted electrical stimulation device.
- Prior injury to the vagus nerve.
- Presence of any other implanted investigational device.
- Neck circumference of > 18.5 inches or significant overlying tissue and/or scarring that may hinder device communication.
- Psychiatric, psychosocial, and/or cognitive disorder or impairment that could interfere with study participation as assessed by medical evaluation.
Current or past: (a) medical (psychiatric, non-psychiatric) condition, disease, disorder, injury, or disability*; or (b) non-medical situation or circumstance that, in the opinion of the Site PI, study participation:
- may pose a significant or undue risk to the person;
- make it unlikely the person will complete all the study requirements per protocol; or
- may adversely impact the integrity of the data or the validity of the study results.
[*Examples include, but are not limited to, the following types of conditions, diseases or disorders: renal insufficiency or failure, vascular disease, unstable or concerning cardiac disease, endocrinologic concerns (e.g., poorly controlled diabetes), immunosuppression, respiratory issues, psychiatric (e.g., schizophrenia), neurologic (e.g., cognitive, seizure), sickle cell disease, lupus, clotting disorders, active neoplastic disease (excluding basal or squamous cell carcinoma of the skin with intent for curative excision), recent documented history (within the last 3 months) of dysphagia or aspiration difficulty]
- Is female and lactating, pregnant, or plans to become pregnant during the study. Participants of child-bearing potential that are sexually active must use a reliable form of birth control. Acceptable birth control methods: (a) sterilization surgery for women, (b) surgical sterilization implant for women, (c) sterilization surgery for men (including all male partners), (d) Long-acting reversible contraceptives (LARC)-implantable rod and Intrauterine Device (IUD), (e) contraceptive shots/injection every 3 months, (f) oral contraceptives (pills), (g) contraceptive patch, (h) vaginal contraceptive ring, and (i) complete abstinence.
- Abusive use of alcohol or drugs that could interfere with participation, as determined by the Site PI.
- Concurrently participating in another interventional clinical study.
- Requires or plans the use of diathermy, transcranial magnetic stimulation, or electroconvulsive therapy (ECT) during the course of the study.
- Is known to be under incarceration or legal detention as determined by the Site PI.
- Non-English speaking, unless the enrolling site has an IRB-approved translated consent and qualified medical interpreter resources available in the participant's language to support all study visits and procedures.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 네 배로
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: CLV (Immediate start group)
The participants in this arm will be implanted with the device and will receive CLV in double-blind and open-label phases of the study.
|
The participants in this group will be implanted with the ReWire system and receive CLV in the double-blind phase
|
|
위약 비교기: Sham (Delayed start group)
The participants in this arm will be implanted with the device and will receive sham in double-blind phase and CLV in open-label phase of the study.
|
The participants in this group will be implanted with the ReWire system and receive Sham in the double-blind phase
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
ReWire System Safety
기간: From device implantation to up to 2 years following implantation.
|
Safety of the ReWire system will be assessed by documenting the nature, frequency, severity, and relatedness of adverse events associated with the device, including those attributable to device implantation, stimulation delivery, and rehabilitation procedures.
|
From device implantation to up to 2 years following implantation.
|
|
ReWire System Feasibility
기간: All visits after implantation, up to approximately 26 weeks post-enrollment.
|
Feasibility of the ReWire system will be assessed by the proportion of successful stimulation triggering events recorded in the ReWire System log during therapy sessions.
The system will be considered feasible if >50% of valid trigger attempts result in successful stimulation delivery.
|
All visits after implantation, up to approximately 26 weeks post-enrollment.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
6 Meter Walk Test (6MWT)
기간: At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
|
This measure assesses gait endurance by measuring the distance walked in 6 minutes along a hallway.
Determine whether CLV improves six-minute walking test (6MWT) score compared to baseline.
This measure is not a scale.
Higher distance covered is better.
|
At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
|
|
10 Meter Walk Test (10MWT)
기간: At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
|
This measure assesses walking speed (meter/second) over a short distance.
Determine whether CLV improves 10-Meter Walk Test (10-MWT) score compared to baseline.
This measure is not a scale.
Lower time to complete is better.
|
At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
|
|
Timed Up-and Go (TUG)Test
기간: At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
|
This measure assesses the functional mobility and fall risk by timing participants as they stand from a seated position, walk to a set point, and return to sit.
Determine whether CLV improves Timed Up-and Go (TUG)Test score compared to baseline.
This measure is not a scale.
Lower time to complete is better.
|
At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
|
|
Walking Index for Spinal Cord Injury II (WISCI II)
기간: At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
|
This measure assesses the type and amount of assistance required for walking.
Determine whether CLV improves Walking Index for Spinal Cord Injury II (WISCI II) score compared to baseline.
This scale is from 0-20.
Higher scores indicate better walking performance.
|
At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
|
|
Lower Extremity Motor Score (LEMS)
기간: At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
|
This measure quantifies the strength of five key muscle groups in each lower extremity.
Determine whether CLV improves Lower Extremity Motor Score (LEMS) compared to baseline.
This scale is from 0 to 50.
Higher scores are better.
|
At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
|
|
SCI-Functional Independence Scale - Ambulation Subsection (SCI-FIS)
기간: At baseline (screening), after implantation, week 14 (double-blind phase), week 22 (Open-label phase) and week 26 (1 month follow-up).
|
This measure assesses self-perceived limitations with walking and basic mobility.
This scale is from 0-24.
Higher scores indicate better function.
|
At baseline (screening), after implantation, week 14 (double-blind phase), week 22 (Open-label phase) and week 26 (1 month follow-up).
|
|
SCI Independence Measure (SCIM) III
기간: At baseline (screening), after implantation, week 14 (double-blind phase), week 22 (Open-label phase) and week 26 (1 month follow-up).
|
This measure assesses the functional independence (ability to safely perform daily activities without physical or cognitive assistance).
This scale is from 0-100.
Higher scores indicate greater independence.
|
At baseline (screening), after implantation, week 14 (double-blind phase), week 22 (Open-label phase) and week 26 (1 month follow-up).
|
|
International SCI Pain Basic Data Set
기간: At baseline (screening), after implantation, week 14 (double-blind phase), week 22 (Open-label phase) and week 26 (1 month follow-up).
|
This measure is not a scale.
It is a questionnaire consisting of items regarding overall pain and items regarding each of the three worst pain problems (assesses pain intensity and classification for each specific pain) in SCI patients.
|
At baseline (screening), after implantation, week 14 (double-blind phase), week 22 (Open-label phase) and week 26 (1 month follow-up).
|
|
Observed Functional Change Assessment (OFCA)
기간: At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
|
This measure is not a scale.
It captures participants' reports/observations of positive functional changes (captures emergent functional gains-such as the appearance of new voluntary activation or task initiation-that may not yet be reflected in the numerical thresholds of standardized, performance-based scales).
|
At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
|
|
Participant Satisfaction Survey
기간: At week 14 (double-blind phase), week 22 (Open-label phase) and week 26 (1 month follow-up).
|
This measure collects participant-reported feedback regarding usability, tolerability, and overall experience with CLV therapy.
|
At week 14 (double-blind phase), week 22 (Open-label phase) and week 26 (1 month follow-up).
|
|
Participant Blinding Questionnaire
기간: At week 14 (double-blind phase).
|
This measure is not a scale.
It assesses effectiveness of blinding from the participant perspective.
|
At week 14 (double-blind phase).
|
|
Therapist Blinding Questionnaire
기간: At week 14 (double-blind phase).
|
This measure is not a scale.
It assesses effectiveness of blinding from the treating therapist perspective.
|
At week 14 (double-blind phase).
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
수사관
수사관
- 수석 연구원: Jane Wigginton, MD, The University of Texas at Dallas
- 수석 연구원: Robert Rennaker, PhD, The University of Texas at Dallas
- 수석 연구원: Seth Hays, PhD, The University of Texas at Dallas
- 수석 연구원: Rita Hamilton, DO, Baylor University Medical Center (BUMC)
- 수석 연구원: Chad Swank, PhD, Spaulding Rehabilitation Hospital, Mass General Brigham
- 수석 연구원: Michael Foreman, MD, Urgent Surgery Associates, PA
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2026년 9월 30일
기본 완료 (추정된)
기본 완료
2028년 12월 1일
연구 완료 (추정된)
연구 완료
2028년 12월 1일
연구 등록 날짜
최초 제출
최초 제출
2026년 6월 17일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 6월 30일
처음 게시됨 (실제)
처음 게시됨
2026년 7월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 7월 27일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 23일
마지막으로 확인됨
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
기타 연구 ID 번호
- IRB-26-521
- 5UG3NS131971-02 (미국 NIH 보조금/계약)
- BSW 026-341 (기타 식별자: Baylor Scott & White Research Institute)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Demographic level data and outcomes.
IPD 공유 기간
Upon publication of main study findings.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
예
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. .