Harnessing Neuroplasticity to Enhance Functional Recovery During Chronic Recovery From Upper Extremity Nerve Repair

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Missouri-Columbia
Study ID
NCT03610763
Status
Recruiting
Apply to this trial

Conditions

  • Hand Transplantation
  • Neurologic Rehabilitation
  • Peripheral Nerve Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transcranial Direct Current Stimulation — DEVICE
    Transcranial direct current stimulation (tDCS) is a portable neurostimulation method that modulates cortical excitability. The technique involves placing two saline-soaked electrodes (anode and cathode) on the scalp and passing a small direct current (1.5 milliamps; mA) between them. Cortex underlying the anode is more easily excited due to lowered thresholds for depolarization of glutamatergic neurons, while thresholds are increased in neurons beneath the cathode, making them less excitable. Sham stimulation is easily implemented, and the technique can be effectively double-blinded.
  • Modified Constraint Induced Movement Therapy — BEHAVIORAL
    In CIMT, patients are required to wear a mitt that restricts use of the unaffected limb while they practice structured tasks and also engage in activities of daily living.

Study Details

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.

Key Dates

Start date
Aug 15, 2018
Status verified
Jun 2024
Primary completion
Jun 1, 2025
Completion
Jun 1, 2025

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Transplantation/Replantation Patients
    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)?
  • Active Comparator: Nerve Injury Patients active
    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)?
  • No Intervention: Actigraphy Testing
    We will acquire a set of actigraphy data from a group of hand transplant/replant patients and unilateral, adult amputees in order to evaluate typical patterns of limb use prior to hand transplantation and to investigate prosthesis utilization.

Primary Outcome Measure

Change from Baseline Dellon Modified Moberg Pick-Up Test performance at two weeks. [ Time Frame: Baseline, immediately after end of intervention (+/- 3 days). ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Christine Kleinert Institute for Hand & MicrosurgeryLouisvilleKentucky40202
Christina Kaufman, Ph.D.
[email protected]
502-562-0390
University of MissouriColumbiaMissouri65211
Scott H Frey, Ph.D., Ed.M.
[email protected]
573-882-4572
Washington University School of MedicineSt LouisMissouri63110
Amy Moore, MD
[email protected]
314-454-4894

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By research site
Christine Kleinert Institute for Hand & Microsurgery· Louisville, KYUniversity of Missouri· Columbia, MOWashington University School of Medicine· St Louis, MO

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