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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).

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

20

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02129
        • Spaulding Rehabilitation Hospital, Mass General Brigham
        • 主任研究者：
          • Chad Swank, PhD
        • コンタクト：
    • Texas
      • Dallas、Texas、アメリカ、75246
        • Baylor University Medical Center (BUMC)
        • コンタクト：
        • 主任研究者：
          • Rita Hamilton, DO
      • Dallas、Texas、アメリカ、75204
        • Urgent Surgery Associates, PA
        • 主任研究者：
          • Michael Foreman, MD
        • コンタクト：
      • Richardson、Texas、アメリカ、75080
        • Texas Biomedical Device Center
        • コンタクト：
        • 主任研究者：
          • Robert Rennaker, PhD
        • 主任研究者：
          • Jane Wigginton, MD
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：クロスオーバー割り当て
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
デバイス：CLV
The participants in this group will be implanted with the ReWire system and receive CLV in the double-blind phase
プラセボコンパレーター：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.
デバイス：Sham
The participants in this group will be implanted with the ReWire system and receive Sham in the double-blind phase

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
ReWire System Safety
時間枠：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
時間枠：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.

二次結果の測定

結果測定
メジャーの説明
時間枠
6 Meter Walk Test (6MWT)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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).

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

The University of Texas at Dallas

協力者

National Institute of Neurological Disorders and Stroke (NINDS)

捜査官

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

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月30日

一次修了 (推定)

2028年12月1日

研究の完了 (推定)

2028年12月1日

試験登録日

最初に提出

2026年6月17日

QC基準を満たした最初の提出物

2026年6月30日

最初の投稿 (実際)

2026年7月8日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月27日

QC基準を満たした最後の更新が送信されました

2026年7月23日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • IRB-26-521
  • 5UG3NS131971-02 (米国 NIH グラント/契約)
  • BSW 026-341 (その他の識別子：Baylor Scott & White Research Institute)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

Demographic level data and outcomes.

IPD 共有時間枠

Upon publication of main study findings.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • ICF

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

はい

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