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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
Spaulding Rehabilitation Hospital, Mass General Brigham
Boston, Massachusetts, United States
Urgent Surgery Associates, PA
Dallas, Texas, United States
Baylor University Medical Center (BUMC)
Dallas, Texas, United States
Texas Biomedical Device Center
Richardson, Texas, United States
ReWire System Safety
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.
Time frame: From device implantation to up to 2 years following implantation.
ReWire System Feasibility
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.
Time frame: All visits after implantation, up to approximately 26 weeks post-enrollment.
6 Meter Walk Test (6MWT)
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.
Time frame: At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
10 Meter Walk Test (10MWT)
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.
Time frame: At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
Timed Up-and Go (TUG)Test
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.
Time frame: At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
Walking Index for Spinal Cord Injury II (WISCI II)
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.
Time frame: At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
Lower Extremity Motor Score (LEMS)
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.
Time frame: At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
SCI-Functional Independence Scale - Ambulation Subsection (SCI-FIS)
This measure assesses self-perceived limitations with walking and basic mobility. This scale is from 0-24. Higher scores indicate better function.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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)
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).
Time frame: At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
Participant Satisfaction Survey
This measure collects participant-reported feedback regarding usability, tolerability, and overall experience with CLV therapy.
Time frame: At week 14 (double-blind phase), week 22 (Open-label phase) and week 26 (1 month follow-up).
Participant Blinding Questionnaire
This measure is not a scale. It assesses effectiveness of blinding from the participant perspective.
Time frame: At week 14 (double-blind phase).
Therapist Blinding Questionnaire
This measure is not a scale. It assesses effectiveness of blinding from the treating therapist perspective.
Time frame: At week 14 (double-blind phase).
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