The University of Texas at Dallas
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).
A prospective, multi-center, non-randomized, open label extension of the SCI EFS trial (NCT04288245) participants implanted with the investigational ReStore Device for VNS Therapy. Following the completion of Phase 2 of the SCI EFS study, participants can enroll to one of the four tracks. Under each track, participants will undergo up to 36 sessions of rehabilitative exercises self-paced by participants with targeted completion of 3 sessions per week. Evaluations will be administered at the beginning and end of each track (additional progress checks may be conducted, as required by the staff)…
General Inclusion Criteria: 1. Completed phase 2 of the SCI EFS study (NCT04288245) 2. Willing to comply with procedures for the entire duration of the study (study protocol compliance) 3. Provision of signed and dated informed consent form 4. Access to reliable communication and internet connections (for those intending to complete sessions at home) 5. Has not had their VNS device explanted General Exclusion Criteria: 1. Concurrent participation in another active interventional trial or participation in an active interventional trial within 7 days prior to enrollment 2. Any medical conditi…
Subjects will receive active VNS paired with track-specific rehabilitation exercises.
Arctuva estimate
Actual pay is set by the research site.
Verify or correct the compensation shown for this listing.