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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Missouri-Columbia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Individuals with significant/severe brain trauma

Serious psychiatric conditions

Chronic or severe neurological conditions.

Current pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Transplantation/Replantation PatientsActive comparator 2 interventions
Group B: Nerve Injury Patients activeActive comparator 2 interventions
Group C: Actigraphy TestingNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change from Baseline Dellon Modified Moberg Pick-Up Test performance at two weeks.

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.

Time frame
Baseline, immediately after end of intervention (+/- 3 days).

Secondary outcomes

1

Change from Baseline Action Research Arm Test (ARAT) performance at two weeks.

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.

Time frame
Baseline, immediately after end of intervention (+/- 3 days).
2

Change from baseline upper limb movement as measured by actigraphy-derived variables during everyday life at periodic intervals after intervention.

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.

Time frame
Baseline, post intervention at week 1, post intervention at 1 month, post intervention at 3 months, post intervention at 6 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Missouri-Columbia

Lead sponsor

Washington University School of Medicine

Collaborator

Christine M. Kleinert Institute for Hand and Microsurgery

Collaborator