Brain Stimulation + Behavioral Training for Peripheral Nerve Injury
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Missouri-Columbia
Disqualifiers: Brain trauma, Psychiatric conditions, Neurological conditions, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Brain Stimulation + Behavioral Training for Peripheral Nerve Injury?
Research shows that Constraint-Induced Movement Therapy (CIMT) is effective for improving arm and hand function in people recovering from strokes and brain injuries. This suggests that similar approaches, like the one in this trial, might help with nerve injuries too.
12345Is the combination of brain stimulation and behavioral training for peripheral nerve injury safe for humans?
Constraint-induced movement therapy (CIMT) and its modified versions have been used safely in stroke rehabilitation to improve arm function, suggesting that these therapies are generally safe for human use.
678910How is Modified Constraint-Induced Movement Therapy different from other treatments for peripheral nerve injury?
Modified Constraint-Induced Movement Therapy (CIMT) is unique because it involves intensive practice using the affected limb while restricting the use of the unaffected limb, which encourages the brain to adapt and improve function. This approach is different from traditional therapies that may not focus as intensively on using the affected limb.
1261112Eligibility Criteria
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.Inclusion Criteria
My hand was reattached after amputation and I'm 12-18 months post-surgery.
I had surgery for a severe forearm cut and it's been 12-18 months since.
I had a hand transplant over a year ago and have recovered.
Exclusion Criteria
Individuals with metallic implants above the chest
Individuals with certain implanted medical devices
I have had seizures or unexplained fainting episodes.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive bi-hemispheric transcranial direct current stimulation (tDCS) combined with modified Constraint Induced Movement Therapy (CIMT) to enhance functional recovery
2 weeks
Follow-up
Participants are monitored for changes in upper limb movement and function using actigraphy and functional tests
6 months
Post intervention at week 1, 1 month, 3 months, and 6 months
Participant Groups
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.
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)?
Modified Constraint Induced Movement Therapy is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Constraint-Induced Movement Therapy for:
- Stroke rehabilitation
- Upper limb rehabilitation
🇪🇺 Approved in European Union as Modified CIMT for:
- Stroke rehabilitation
- Upper limb rehabilitation
- Peripheral nerve injuries
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Christine Kleinert Institute for Hand & MicrosurgeryLouisville, KY
University of MissouriColumbia, MO
Washington University School of MedicineSaint Louis, MO
Loading ...
Who Is Running the Clinical Trial?
University of Missouri-ColumbiaLead Sponsor
Christine M. Kleinert Institute for Hand and MicrosurgeryCollaborator
Washington University School of MedicineCollaborator
References
Phase II Randomized Controlled Trial of Constraint-Induced Movement Therapy in Multiple Sclerosis. Part 1: Effects on Real-World Function. [2019]Constraint-Induced Movement therapy (CIMT) has controlled evidence of efficacy for improving real-world paretic limb use in non-progressive physically disabling disorders (stroke, cerebral palsy).
Occupation-based intervention versus rote exercise in modified constraint-induced movement therapy for patients with median and ulnar nerve injuries: a randomized controlled trial. [2018]To investigate effect of practice type during modified constraint-induced movement therapy on hand function in patients with chronic median and ulnar nerve injuries.
Constraint-induced movement therapy for upper limb recovery in adult neurorehabilitation: An international survey of current knowledge and experience. [2020]Constraint-induced movement therapy (CIMT) is an effective intervention for upper limb recovery following stroke and traumatic brain injury. Despite strong evidence, the use of CIMT in practice is limited. The aim of this study was to investigate clinician knowledge and experience of delivering CIMT protocols internationally in neurorehabilitation.
Shoulder complex and trunk coordination of individuals with severe hemiparesis following a constraint-induced movement therapy protocol: A case series. [2023]Constraint Induced Movement Therapy (CIMT) has been shown to be an effective rehabilitation technique in individuals with mild and moderate upper limb (UL) hemiparesis. The aim was to evaluate the effect the CIMT for improving paretic UL use and interjoint coordination with individuals in severe hemiparesis.
Feasibility of electromyography-triggered neuromuscular stimulation as an adjunct to constraint-induced movement therapy. [2016]The purpose of this case report is to explore the feasibility of electromyography-triggered neuromuscular stimulation (EMG-stim) as an adjunct to constraint-induced movement therapy (CIMT).
Reduced-intensity modified constraint-induced movement therapy versus conventional therapy for upper extremity rehabilitation after stroke: a multicenter trial. [2016]Constraint-induced movement therapy (CIMT) is a rehabilitation approach for arm paresis consisting of an intensive schedule of treatment (6 h/d). The high demand of resources for CIMT is a critical issue for its implementation in the Italian health system.
Very Early Constraint-Induced Movement during Stroke Rehabilitation (VECTORS): A single-center RCT. [2022]Constraint-induced movement therapy (CIMT) is among the most developed training approaches for motor restoration of the upper extremity (UE).
Efficacy of modified constraint-induced movement therapy in acute stroke. [2022]Modified constraint induced movement therapy (m-CIMT) discourages the use of the unaffected extremity and encourages the active use of the hemiplegic arm in order to restore the motor function.
Barriers to the implementation of constraint-induced movement therapy into practice. [2022]Constraint-induced movement therapy (CIMT) has been studied for many years in the treatment of the hemiplegic upper extremity (UE). However, there has been limited adoption of the protocol in daily practice.
Study to assess the effectiveness of modified constraint-induced movement therapy in stroke subjects: A randomized controlled trial. [2021]The purpose of this study was to assess the effectiveness of modified constraint induced movement therapy (m-CIMT) in stroke subjects.
Phase II Randomized Controlled Trial of Constraint-Induced Movement Therapy in Multiple Sclerosis. Part 2: Effect on White Matter Integrity. [2019]Constraint-induced movement therapy (CIMT) is a method of physical rehabilitation that has demonstrated clinical efficacy in patients with chronic stroke, cerebral palsy, and multiple sclerosis (MS).
Short- and long-term outcome of constraint-induced movement therapy after stroke: a randomized controlled feasibility trial. [2016]Constraint-induced movement therapy (CIMT) is a method to improve motor function in the upper extremity following stroke. The aim of this trial was to determine the effect and feasibility of CIMT compared with traditional rehabilitation in short and long term.