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Closed-Loop Vagus Nerve Stimulation (CLV) for Recovery of Gait

30. června 2026 aktualizováno: 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)

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).

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

20

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Spojené státy
    • Massachusetts
      • Boston, Massachusetts, Spojené státy, 02129
        • Spaulding Rehabilitation Hospital, Mass General Brigham
        • Vrchní vyšetřovatel:
          • Chad Swank, PhD
        • Kontakt:
    • Texas
      • Dallas, Texas, Spojené státy, 75246
        • Baylor University Medical Center (BUMC)
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Rita Hamilton, DO
      • Dallas, Texas, Spojené státy, 75204
        • Urgent Surgery Associates, PA
        • Vrchní vyšetřovatel:
          • Michael Foreman, MD
        • Kontakt:
      • Richardson, Texas, Spojené státy, 75080
        • Texas Biomedical Device Center
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Robert Rennaker, PhD
        • Vrchní vyšetřovatel:
          • Jane Wigginton, MD
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Přístroj: CLV
The participants in this group will be implanted with the ReWire system and receive CLV in the double-blind phase
Komparátor placeba: 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.
Přístroj: Sham
The participants in this group will be implanted with the ReWire system and receive Sham in the double-blind phase

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
ReWire System Safety
Časové okno: 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
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
6 Meter Walk Test (6MWT)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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).

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

The University of Texas at Dallas

Spolupracovníci

National Institute of Neurological Disorders and Stroke (NINDS)

Vyšetřovatelé

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

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

30. září 2026

Primární dokončení (Odhadovaný)

1. prosince 2028

Dokončení studie (Odhadovaný)

1. prosince 2028

Termíny zápisu do studia

První předloženo

17. června 2026

První předloženo, které splnilo kritéria kontroly kvality

30. června 2026

První zveřejněno (Aktuální)

8. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

30. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • IRB-xx-xxx
  • 5UG3NS131971-02 (Grant/smlouva NIH USA)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

Demographic level data and outcomes.

Časový rámec sdílení IPD

Upon publication of main study findings.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • ICF

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ano

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Podmínky

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