Vagus Nerve Stimulation (VNS) in Spinal Cord Injury (SCI) Adaptive Follow-On Study

Part of paid clinical trials in Dallas, Texas.

Sponsor
The University of Texas at Dallas
Study ID
NCT06351111
Status
Enrolling By Invitation

Conditions

  • SCI - Spinal Cord Injury

Eligibility Criteria

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

Interventions

  • Active VNS — DEVICE
    Subjects will receive active VNS paired with track-specific rehabilitation exercises.

Study Details

This study is an open label extension of the SCI EFS clinical trial (NCT04288245) that developed an innovative strategy to enhance recovery of motor and sensory function after neurological injury. The objectives of this study are to provide continued safety assessment for the investigational ReStore system, and to gain further estimate of the effect of Vagus Nerve Stimulation (VNS) with rehabilitative exercises in four different tracks - upper limb (UL), lower limb (LL), bladder control (BC), and sensory (SY) for participants with chronic SCI (Spinal Cord Injury).

Key Dates

Start date
Aug 29, 2024
Status verified
Jun 2026
Primary completion
May 31, 2027
Completion
May 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Upper limb (UL)
    Participants in this arm will receive up to 36 sessions of VNS paired with upper limb rehabilitative exercises
  • Experimental: Lower limb (LL)
    Participants in this arm will receive up to 36 sessions of VNS paired with lower limb rehabilitative exercises
  • Experimental: Bladder control (BC)
    Participants in this arm will receive up to 36 sessions of VNS paired with bladder control rehabilitative exercises
  • Experimental: Sensory (SY)
    Participants in this arm will receive up to 36 sessions of VNS paired with sensory rehabilitative exercises

Primary Outcome Measure

Incidence of adverse events (device safety) [ Time Frame: Starting at session 1 on week 1, throughout the study up to last session 36 on week 15. ]

Locations (2)

FacilityCityStateZIPSite coordinators
Baylor University Medical CenterDallasTexas75246-
Texas Biomedical Device CenterRichardsonTexas75080-

Find similar trials in Dallas, TX

By research site
Baylor University Medical Center· Dallas, TXTexas Biomedical Device Center· Richardson, TX

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