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Brain Stimulation + Behavioral Training for Peripheral Nerve Injury

N/A

Recruiting

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

Research Sponsored by University of Missouri-Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individuals who 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)

Be older than 18 years old

Must not have

Individuals with a history of seizures or unexplained loss of consciousness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, immediately after end of intervention (+/- 3 days).

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a brain stimulation technique to help improve recovery after nerve injuries in hands and arms. It combines behavioral training with electric stimulation.

Who is the study for?

This trial is for people who've had certain hand surgeries like transplants or nerve repairs and are in the later stages of recovery (about a year to a year and a half post-surgery). It's not for those with severe brain injuries, serious mental health issues, chronic neurological conditions, pregnancy, seizure history, or specific implants.

What is being tested?

The study tests if combining behavior training with non-invasive brain stimulation called tDCS can help the brain adapt better after hand surgery. Participants will undergo Transcranial Direct Current Stimulation along with Modified Constraint Induced Movement Therapy.

What are the potential side effects?

tDCS may cause mild side effects such as itching, tingling at the stimulation site, headache, fatigue or nausea. However, it's generally considered safe and these sensations typically fade shortly after treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had surgery for a severe forearm cut and it's been 12-18 months since.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had seizures or unexplained fainting episodes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, immediately after end of intervention (+/- 3 days).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, immediately after end of intervention (+/- 3 days).

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediately after end of intervention (+/- 3 days). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: Transplantation/Replantation PatientsActive Control2 Interventions

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)?

Group II: Actigraphy TestingActive Control1 Intervention

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.

Group III: Nerve Injury Patients activeActive Control2 Interventions

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)?

0 / 2Eligibility criteria met