Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID03610763

Harnessing Neuroplasticity to Enhance Functional Recovery in Allogeneic Hand Transplant and Heterotopic Hand Replant Recipients

Led by University of Missouri-Columbia · Updated on 2024-06-12

180

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Missouri-Columbia

Lead Sponsor

W

Washington University School of Medicine

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a new rehabilitation approach for people recovering from peripheral nervous system injuries, including hand transplantation, hand replantation, and nerve repairs in the upper extremity. This approach is based on neuroscience discoveries about brain plasticity and aims to improve functional recovery by combining behavioral training with a non-invasive brain stimulation technique called transcranial direct current stimulation (tDCS). The study uses a combination of bi-hemispheric tDCS and modified Constraint Induced Movement Therapy (CIMT), where patients wear a mitt to restrict movement of the unaffected limb while practicing structured tasks and daily activities. The program targets individuals in the chronic stage of recovery, about 12 to 18 months after surgery. In addition, the study collects data on limb use patterns through actigraphy in hand transplant/replant patients and amputees to better understand prosthesis use and limb activity. Participants will undergo assessments including the Dellon Modified Moberg Pick-Up Test and the Action Research Arm Test to measure hand function changes from baseline to two weeks after the intervention. Movement during everyday life will be monitored through actigraphy at multiple time points up to six months after treatment. The study includes randomized assignment to treatment groups and uses double-blinding methods. The total participation time varies by individual, including baseline evaluation, intervention, and follow-up assessments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Individuals with a unilateral hand transplant above the wrist in the chronic recovery stage (about 12-18 months after surgery)
  • Individuals with a complete hand amputation between wrist and elbow followed by successful re-attachment in the chronic recovery stage (about 12-18 months after surgery)
  • Individuals who have had median, ulnar, or related nerve repairs in the forearm between the wrist and flexor musculotendinous junctions in the chronic recovery stage (about 12-18 months after surgery)
Not Eligible

You will not qualify if you...

  • Significant or severe brain trauma
  • Serious psychiatric conditions
  • Chronic or severe neurological conditions
  • Current pregnancy
  • History of seizures or unexplained loss of consciousness
  • Presence of metallic implants above the chest
  • Certain implanted medical devices

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 2 weeks

Participants receive bi-hemispheric transcranial direct current stimulation combined with modified Constraint Induced Movement Therapy to facilitate hand function recovery.

Multiple visits during the 2-week intervention period

Follow-up

Duration - 6 months

Participants are monitored for changes in upper limb movement and functional performance after the intervention.

Visits at week 1, 1 month, 3 months, and 6 months post intervention

Trial Site Locations

Total: 3 locations

1

Christine Kleinert Institute for Hand & Microsurgery

Louisville, Kentucky, United States, 40202

Actively Recruiting

2

University of Missouri

Columbia, Missouri, United States, 65211

Actively Recruiting

3

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

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Research Team

S

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

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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