Improving upper limb function in cervical spinal cord injury using vagus nerve stimulation and rehabilitation
Safety and Feasibility of Paired Vagus Nerve Stimulation With Rehabilitation for Improving Upper Extremity Function in People With Cervical Spinal Cord Injury: A Pilot Randomized Control Trial.
NA · The University of Texas Health Science Center, Houston · NCT05601661
This study is testing if combining vagus nerve stimulation with rehabilitation can help adults with incomplete cervical spinal cord injuries improve their upper limb movement.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston (other) |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05601661 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and feasibility of combining vagus nerve stimulation (VNS) with rehabilitation to enhance upper limb motor recovery in adults with incomplete cervical spinal cord injury (SCI). In a double-blinded, randomized, placebo-controlled pilot trial, participants will be implanted with a VNS device and assigned to either active or control VNS while undergoing rehabilitation therapy. The rehabilitation consists of in-clinic sessions and a home exercise program over a 90-day period. The study will assess safety through surgical and therapy-related events and feasibility through participant compliance and attrition rates, while efficacy will be measured by improvements in upper limb function.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with traumatic incomplete cervical spinal cord injuries who have some residual upper limb movement.
Not a fit: Patients with non-traumatic spinal cord injuries or significant comorbidities that interfere with the study's interventions may not benefit.
Why it matters
Potential benefit: If successful, this approach could significantly improve upper limb function and quality of life for individuals with cervical spinal cord injuries.
How similar studies have performed: While this approach is novel, similar studies exploring VNS for rehabilitation have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * a diagnosis of traumatic incomplete (AIS B-D) cervical spinal cord injury (C8 and above) * at least 12 months post-traumatic SCI * demonstrate some residual movement in the upper limb (e.g., able to perform pinch movement with thumb and index finger) * meet all clinical criteria for the surgical VNS implantation as determined by the PI, neurosurgeon, and anesthesiologist. Exclusion Criteria: * non-traumatic SCI, injury * presence of ongoing dysphasia or aspiration difficulties * evidence of vagus pre-existing vocal cord paralysis as determined with laryngoscopy procedure * participants with prior left-sided anterior cervical surgery who exhibit too much of scar tissue at the surgery site which will be determined by neurosurgeon * concomitant clinically significant brain injury * history of prior injury to a vagus nerve * receiving medication that may significantly interfere with the actions of VNS on neurotransmitter systems at study entry * other comorbidities or complications that will hinder or contraindicate surgical procedure * medical or mental instability * pregnancy or plans to become pregnant during the study period.
Where this trial is running
Houston, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Radha Korupolu — The University of Texas Health Science Center, Houston
- Study coordinator: Radha Korupolu, MD
- Email: Radha.Korupolu@uth.tmc.edu
- Phone: 713-797-5233
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cervical Spinal Cord Injury, vagus nerve stimulation