Clinical trial NCT03610763: Harnessing Neuroplasticity to Enhance Functional Recovery During Chronic Recovery From Upper Extremity Nerve Repair
Official title: Harnessing Neuroplasticity to Enhance Functional Recovery in Allogeneic Hand Transplant and Heterotopic Hand Replant Recipients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hand Transplantation
Peripheral Nerve Injuries
Neurologic Rehabilitation
Keywords: Rehabilitation Neuroscience
Transcranial Direct Current Stimulation
Rehabilitation Therapy
Neuroplasticity
Transplantation
Hand Therapy
Constraint Induced Movement Therapy
Peripheral Nerve Injuries
tDCS
CIMT
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
name: Christine M. Kleinert Institute for Hand and Microsurgery
First posted: 2018-08-01
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change from Baseline Dellon Modified Moberg Pick-Up Test performance at two weeks.
timeFrame: Baseline, immediately after end of intervention (+/- 3 days).
Secondary outcomes:
measure: Change from Baseline Action Research Arm Test (ARAT) performance at two weeks.
timeFrame: Baseline, immediately after end of intervention (+/- 3 days).
measure: Change from baseline upper limb movement as measured by actigraphy-derived variables during everyday life at periodic intervals after intervention.
timeFrame: Baseline, post intervention at week 1, post intervention at 1 month, post intervention at 3 months, post intervention at 6 months.
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Christine Kleinert Institute for Hand & Microsurgery
state: Kentucky
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Scott H Frey, Ph.D., Ed.M.
role: PRINCIPAL_INVESTIGATOR
References: