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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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.

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor

362 Previous Clinical Trials

627,934 Total Patients Enrolled

Christine M. Kleinert Institute for Hand and MicrosurgeryOTHER

10 Previous Clinical Trials

785 Total Patients Enrolled

Washington University School of MedicineOTHER

1,937 Previous Clinical Trials

2,299,522 Total Patients Enrolled

Media Library

Modified Constraint Induced Movement Therapy Clinical Trial Eligibility Overview. Trial Name: NCT03610763 — N/A

Peripheral Nerve Injury Research Study Groups: Transplantation/Replantation Patients, Actigraphy Testing, Nerve Injury Patients active

Peripheral Nerve Injury Clinical Trial 2023: Modified Constraint Induced Movement Therapy Highlights & Side Effects. Trial Name: NCT03610763 — N/A

Modified Constraint Induced Movement Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03610763 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total enrollment capacity for this clinical trial?

"Affirmative, the information available on clinicaltrials.gov states that this research is recruiting patients as of now. It was initially posted on August 15th 2018 and its most recent update came out May 12th 2023. 180 individuals are needed across 3 sites for enrolment into the trial."

Answered by AI

Are there any vacancies left for individuals to join this medical trial?

"Indeed, the data hosted on clinicaltrials.gov suggests that this medical study is actively enrolling patients since it was first launched on August 15th 2018 and last updated on May 12th 2023. This trial seeks to recruit 180 participants from 3 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Scott H Frey, PhD 2018. "Harnessing Neuroplasticity to Enhance Functional Recovery During Chronic Recovery From Upper Extremity Nerve Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03610763.

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