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

NCT03610763 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2024-06-12

No results posted yet for this study

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

Interventions

DEVICE

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • Washington University School of Medicine

    collaborator OTHER
  • Christine M. Kleinert Institute for Hand and Microsurgery

    collaborator OTHER
  • University of Missouri-Columbia

    lead OTHER

Principal Investigators

  • Scott H Frey, Ph.D., Ed.M. · University of Missouri-Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-15
Primary Completion
2025-06-01
Completion
2025-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03610763 on ClinicalTrials.gov