Harnessing Neuroplasticity to Enhance Functional Recovery During Chronic Recovery From Upper Extremity Nerve Repair
- Conditions
- Peripheral Nerve InjuriesHand TransplantationNeurologic Rehabilitation
- Interventions
- Device: Transcranial Direct Current StimulationBehavioral: Modified Constraint Induced Movement Therapy
- Registration Number
- NCT03610763
- Lead Sponsor
- University of Missouri-Columbia
- Brief Summary
This study adopts a strategy that has arisen from basic neuroscience research on facilitating adaptive brain plasticity and applies this to rehabilitation to improve functional recovery in peripheral nervous system injuries (including hand transplantation, hand replantation, and surgically repaired upper extremity nerve injuries). The technique involves combining behavioral training with transcranial direct current stimulation (tDCS)-a non-invasive form of brain stimulation capable of facilitating adaptive changes in brain organization.
- Detailed Description
This study will implement and evaluate an innovative program of post hand transplant rehabilitation; one that harnesses recent discoveries in neuroscience to facilitate long-term, experience-dependent adaptations within the brain's sensory and motor systems. The current approach to rehabilitation of function in allogeneic hand transplant recipients is largely the same as standard-of-care following hand replantation (re-attachment) and peripheral nerve repairs. This involves an eclectic combination of traditional therapies. In seeking to improve on this approach, there is potentially much to be gained by considering evidence that limb amputation not only impacts the peripheral nervous system but also the brain, and tailoring interventions accordingly.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transplantation/Replantation Patients Transcranial Direct Current Stimulation Can plateaued hand function in hand transplantation patients/hand replantation patients in the chronic stage of recovery be facilitated by use of bi-hemispheric transcranial direct current stimulation (tDCS) combined with modified Constraint Induced Movement Therapy (CIMT)? Nerve Injury Patients active Transcranial Direct Current Stimulation Can plateaued hand function in peripheral nervous system injuries in the chronic stage of recovery be facilitated by use of bi-hemispheric transcranial direct current stimulation (tDCS) combined with modified Constraint Induced Movement Therapy (CIMT)? Transplantation/Replantation Patients Modified Constraint Induced Movement Therapy Can plateaued hand function in hand transplantation patients/hand replantation patients in the chronic stage of recovery be facilitated by use of bi-hemispheric transcranial direct current stimulation (tDCS) combined with modified Constraint Induced Movement Therapy (CIMT)? Nerve Injury Patients active Modified Constraint Induced Movement Therapy Can plateaued hand function in peripheral nervous system injuries in the chronic stage of recovery be facilitated by use of bi-hemispheric transcranial direct current stimulation (tDCS) combined with modified Constraint Induced Movement Therapy (CIMT)?
- Primary Outcome Measures
Name Time Method Change from Baseline Dellon Modified Moberg Pick-Up Test performance at two weeks. Baseline, immediately after end of intervention (+/- 3 days). This functional test measures quality of sensibility of the hand. This outcome measure will investigate any change in participant performance between pre- and post-intervention sessions of the Dellon Modified Moberg Pick-Up Test.
- Secondary Outcome Measures
Name Time Method Change from Baseline Action Research Arm Test (ARAT) performance at two weeks. Baseline, immediately after end of intervention (+/- 3 days). The Action Research Arm Test (ARAT) measures limb function by having participants pick up various objects of different sizes, different weights, and different shapes (e.g., a glass of water, a cricket ball). This secondary outcome measure will investigate any change in participant performance between pre- and post-intervention sessions of the ARAT.
Change from baseline upper limb movement as measured by actigraphy-derived variables during everyday life at periodic intervals after intervention. Baseline, post intervention at week 1, post intervention at 1 month, post intervention at 3 months, post intervention at 6 months. This secondary outcome measure will employ actigraphy on participants to measure limb movement in everyday life before and after the intervention. Participants will wear wrist-watch like devices that contain accelerometers on each upper extremity in 24-72 hour sessions. Two primary variables will quantify upper limb activity from accelerometer data: the Bilateral Magnitude and the Magnitude Ratio. The Bilateral Magnitude quantifies the intensity of activity across both limbs, whereas the Magnitude Ratio quantifies the contribution of each limb to activity.
This outcome measure will investigate the change in the Bilateral Magnitude and Magnitude Ratio between a baseline pre-intervention test and post-intervention actigraphy sessions performed within one week of completion of the intervention, at 1 month post-intervention, 3-months post intervention, and 6-months post intervention.
Trial Locations
- Locations (3)
Christine Kleinert Institute for Hand & Microsurgery
🇺🇸Louisville, Kentucky, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
University of Missouri
🇺🇸Columbia, Missouri, United States