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Closed-Loop Vagus Nerve Stimulation (CLV) for Recovery of Gait After Spinal Cord Injury (SCI)

2026年7月23日 更新者：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).

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

20

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • Massachusetts
      • Boston、Massachusetts、美国、02129
        • Spaulding Rehabilitation Hospital, Mass General Brigham
        • 首席研究员：
          • Chad Swank, PhD
        • 接触：
    • Texas
      • Dallas、Texas、美国、75246
        • Baylor University Medical Center (BUMC)
        • 接触：
        • 首席研究员：
          • Rita Hamilton, DO
      • Dallas、Texas、美国、75204
        • Urgent Surgery Associates, PA
        • 首席研究员：
          • Michael Foreman, MD
        • 接触：
      • Richardson、Texas、美国、75080
        • Texas Biomedical Device Center
        • 接触：
        • 首席研究员：
          • Robert Rennaker, PhD
        • 首席研究员：
          • Jane Wigginton, MD
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Ability to provide signed and dated informed consent.
  2. Willingness and ability to comply with all study procedures and protocol requirements for the duration of the study.
  3. Age 18 to 64 years.
  4. 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.
  5. Ambulatory with residual gait impairment attributable to spinal cord injury.
  6. Self-selected gait speed of < 0.8 m/s as measured by the 10 meter walk test.
  7. Score of 2 or less on at least 4 measures on the Ambulation subsection of the SCI-Functional Independence scale (SCI-FIS).
  8. In otherwise good general health as determined by medical history and physical examination.
  9. Meets all clinical criteria for VNS implantation as determined by the Site PI and clinical care team.

Exclusion Criteria:

  1. Any history of spinal cord injuries by penetrating traumatic, non-traumatic or congenital causes.
  2. 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).
  3. 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).
  4. Concomitant clinically significant brain injuries.
  5. Deficits in language or attention that interfere with study participation.
  6. Presence of any other implanted electrical stimulation device.
  7. Prior injury to the vagus nerve.
  8. Presence of any other implanted investigational device.
  9. Neck circumference of > 18.5 inches or significant overlying tissue and/or scarring that may hinder device communication.
  10. Psychiatric, psychosocial, and/or cognitive disorder or impairment that could interfere with study participation as assessed by medical evaluation.

  11. 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:

    1. may pose a significant or undue risk to the person;
    2. make it unlikely the person will complete all the study requirements per protocol; or
    3. 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]

  12. 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.
  13. Abusive use of alcohol or drugs that could interfere with participation, as determined by the Site PI.
  14. Concurrently participating in another interventional clinical study.
  15. Requires or plans the use of diathermy, transcranial magnetic stimulation, or electroconvulsive therapy (ECT) during the course of the study.
  16. Is known to be under incarceration or legal detention as determined by the Site PI.
  17. 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
设备：CLV
The participants in this group will be implanted with the ReWire system and receive CLV in the double-blind phase
安慰剂比较：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.
设备：Sham
The participants in this group will be implanted with the ReWire system and receive Sham in the double-blind phase

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
ReWire System Safety
大体时间：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
大体时间：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.

次要结果测量

结果测量
措施说明
大体时间
6 Meter Walk Test (6MWT)
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

The University of Texas at Dallas

合作者

National Institute of Neurological Disorders and Stroke (NINDS)

调查人员

  • 首席研究员：Jane Wigginton, MD、The University of Texas at Dallas
  • 首席研究员：Robert Rennaker, PhD、The University of Texas at Dallas
  • 首席研究员：Seth Hays, PhD、The University of Texas at Dallas
  • 首席研究员：Rita Hamilton, DO、Baylor University Medical Center (BUMC)
  • 首席研究员：Chad Swank, PhD、Spaulding Rehabilitation Hospital, Mass General Brigham
  • 首席研究员：Michael Foreman, MD、Urgent Surgery Associates, PA

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月30日

初级完成 (估计的)

2028年12月1日

研究完成 (估计的)

2028年12月1日

研究注册日期

首次提交

2026年6月17日

首先提交符合 QC 标准的

2026年6月30日

首次发布 (实际的)

2026年7月8日

研究记录更新

最后更新发布 (实际的)

2026年7月27日

上次提交的符合 QC 标准的更新

2026年7月23日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IRB-26-521
  • 5UG3NS131971-02 (美国 NIH 拨款/合同)
  • BSW 026-341 (其他标识符：Baylor Scott & White Research Institute)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Demographic level data and outcomes.

IPD 共享时间框架

Upon publication of main study findings.

IPD 共享支持信息类型

  • 研究方案
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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