Recruiting

Neuroplasticity

Sponsor:

University of Missouri-Columbia

Code:

NCT03610763

Conditions

Hand Transplantation

Peripheral Nerve Injuries

Neurologic Rehabilitation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transcranial Direct Current Stimulation

Modified Constraint Induced Movement Therapy

Study Details

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.

Conditions

Hand Transplantation

Peripheral Nerve Injuries

Neurologic Rehabilitation

Study ID

NCT03610763

Start date

Aug 15, 2018

Status verified date

Jun, 2024

Completion date

Jun 1, 2025

Anticipated

Primary completion date

Jun 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Transcranial Direct Current Stimulation

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

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.

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 and Locations

Central contacts

Scott H Frey, Ph.D., Ed.M.

573-882-4572freylab@missouri.edu

Locations

Christine Kleinert Institute for Hand & Microsurgery

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Christina Kaufman, Ph.D.

502-562-0390ckaufman@cmki.org

University of Missouri

Recruiting

Columbia, Missouri, United States, 65211

Contacts

Scott H Frey, Ph.D., Ed.M.

573-882-4572freylab@missouri.edu

Washington University School of Medicine

Recruiting

Saint Louis, Missouri, United States, 63110

Contacts

Amy Moore, MD

314-454-4894mooream@wustl.edu

More Information

Sponsor

University of Missouri-Columbia

Last update posted

Jun 12, 2024

Last verified

Jun, 2024

Keywords

  • Rehabilitation Neuroscience
  • Transcranial Direct Current Stimulation
  • Rehabilitation Therapy
  • Neuroplasticity
  • Transplantation
  • Hand Therapy
  • Constraint Induced Movement Therapy
  • Peripheral Nerve Injuries
  • tDCS
  • CIMT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Missouri-Columbia on 2024-06-12.