Improving recovery after hand transplantation and nerve injuries using brain stimulation
Harnessing Neuroplasticity to Enhance Functional Recovery in Allogeneic Hand Transplant and Heterotopic Hand Replant Recipients
This study is testing if combining brain stimulation with training can help people recover better after hand transplants or nerve injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Missouri-Columbia Academic / other |
| Locations | 3 sites (Louisville, Kentucky and 2 other locations) |
| Trial ID | NCT03610763 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance functional recovery in patients with upper extremity nerve injuries by combining behavioral training with transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique. The approach is based on recent neuroscience discoveries that suggest adaptive brain plasticity can be harnessed to improve rehabilitation outcomes. Participants will be individuals who have undergone hand transplantation or nerve repair and are in the chronic recovery phase, approximately 12 to 18 months post-surgery. The study will evaluate the effectiveness of this innovative rehabilitation program compared to standard care.
Who should consider this trial
Good fit: Ideal candidates are individuals who have received a unilateral hand transplant or have undergone nerve repair and are in the chronic recovery stage.
Not a fit: Patients with significant brain trauma or serious psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve functional recovery and quality of life for patients with upper extremity nerve injuries.
How similar studies have performed: Other studies have shown promise in using brain stimulation techniques for rehabilitation, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals whom have received a unilateral allogeneic transplantation proximal to the wrist and are at the chronic stage of recovery (approx. 12 - 18 months following surgery, when Tinel's sign reaches the distal fingertips). * Individuals whom have undergone a complete amputation the hand between the wrist and elbow followed by successful re-attachment and are at the chronic stage of recovery (approx. 12 - 18 months following surgery, when Tinel's sign reaches the distal fingertips). * Individuals whom have undergone repairs of the median, ulnar, or other related or nearby nerve(s) following complex volar forearm lacerations or other injuries between the distal wrist crease and the flexor musculotendinous junctions. Individuals must be at the chronic stage of recovery (approx. 12 - 18 months following surgery, when Tinel's sign reaches the distal fingertips). Exclusion Criteria: * Individuals with significant/severe brain trauma * Serious psychiatric conditions * Chronic or severe neurological conditions. * Current pregnancy * History of seizures or unexplained loss of consciousness * Metallic implants above the chest * Certain implanted medical devices.
Where this trial is running
Louisville, Kentucky and 2 other locations
- Christine Kleinert Institute for Hand & Microsurgery — Louisville, Kentucky, United States (Recruiting)
- University of Missouri — Columbia, Missouri, United States (Recruiting)
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Scott H Frey, Ph.D., Ed.M. — University of Missouri-Columbia
- Study coordinator: Scott H Frey, Ph.D., Ed.M.
- Email: freylab@missouri.edu
- Phone: 573-882-4572
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.