Harnessing Neuroplasticity to Enhance Functional Recovery During Chronic Recovery From Upper Extremity Nerve Repair
2 other identifiers
interventional
180
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2018
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2018
CompletedFirst Posted
Study publicly available on registry
August 1, 2018
CompletedStudy Start
First participant enrolled
August 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedJune 12, 2024
June 1, 2024
6.8 years
June 23, 2018
June 11, 2024
Conditions
Keywords
Outcome Measures
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.
Baseline, immediately after end of intervention (+/- 3 days).
Secondary Outcomes (2)
Change from Baseline Action Research Arm Test (ARAT) performance at two weeks.
Baseline, immediately after end of intervention (+/- 3 days).
Change from baseline upper limb movement as measured by actigraphy-derived variables during everyday life at periodic intervals after intervention.
Baseline, post intervention at week 1, post intervention at 1 month, post intervention at 3 months, post intervention at 6 months.
Study Arms (3)
Transplantation/Replantation Patients
ACTIVE COMPARATORCan 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)?
Nerve Injury Patients active
ACTIVE COMPARATORCan 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)?
Actigraphy Testing
NO INTERVENTIONWe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Individuals with significant/severe brain trauma
- Serious psychiatric conditions
- Chronic or severe neurological conditions.
- Current pregnancy
- History of seizures or unexplained loss of consciousness
- Metallic implants above the chest
- Certain implanted medical devices.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Christine Kleinert Institute for Hand & Microsurgery
Louisville, Kentucky, 40202, United States
University of Missouri
Columbia, Missouri, 65211, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott H Frey, Ph.D., Ed.M.
University of Missouri-Columbia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Miller Family Professor of Cognitive Neuroscience
Study Record Dates
First Submitted
June 23, 2018
First Posted
August 1, 2018
Study Start
August 15, 2018
Primary Completion
June 1, 2025
Study Completion
June 1, 2025
Last Updated
June 12, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share