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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
The University of Texas at Dallas
Study ID
NCT07689227
Status
Not Yet Recruiting

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Conditions

  • Functional Mobility
  • Gait
  • Lower Limb Functions
  • Mobility Impairment
  • Reduced Physical Activity
  • Spinal Cord Injury (SCI)
  • Walking Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • CLV — DEVICE
    The participants in this group will be implanted with the ReWire system and receive CLV in the double-blind phase
  • Sham — DEVICE
    The participants in this group will be implanted with the ReWire system and receive Sham in the double-blind phase

Study Details

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).

Key Dates

First listed
Jul 8, 2026
Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Placebo Comparator: 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.

Primary Outcome Measure

ReWire System Safety [ Time Frame: From device implantation to up to 2 years following implantation. ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Spaulding Rehabilitation Hospital, Mass General BrighamBostonMassachusetts02129
Jenny Zhang
[email protected]
617-952-6354
Chad Swank, PhD (PRINCIPAL_INVESTIGATOR)
Baylor University Medical Center (BUMC)DallasTexas75246
Niroj Ari
[email protected]
214-820-2821
Rita Hamilton, DO (PRINCIPAL_INVESTIGATOR)
Urgent Surgery Associates, PADallasTexas75204
Madeline Miller
[email protected]
214-821-1599
Michael Foreman, MD (PRINCIPAL_INVESTIGATOR)
Texas Biomedical Device CenterRichardsonTexas75080
Amy Porter
[email protected]
972-883-7256
Alvaro Carrera
[email protected]
972-883-5397
Robert Rennaker, PhD (PRINCIPAL_INVESTIGATOR)
Jane Wigginton, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Spaulding Rehabilitation Hospital, Mass General Brigham· Boston, MABaylor University Medical Center (BUMC)· Dallas, TXUrgent Surgery Associates, PA· Dallas, TXTexas Biomedical Device Center· Richardson, TX

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