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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03610763
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : July 1, 2020
Sponsor:
Collaborators:
Washington University School of Medicine
Christine M. Kleinert Institute for Hand and Microsurgery
Information provided by (Responsible Party):
Scott H Frey, PhD, University of Missouri-Columbia

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.

Condition or disease Intervention/treatment Phase
Hand Transplantation Peripheral Nerve Injuries Neurologic Rehabilitation Device: Transcranial Direct Current Stimulation Behavioral: Modified Constraint Induced Movement Therapy Not Applicable

Detailed Description:
This study will implement and evaluate an innovative program of post hand transplant rehabilitation; one that harnesses recent discoveries in neuroscience to facilitate long-term, experience-dependent adaptations within the brain's sensory and motor systems. The current approach to rehabilitation of function in allogeneic hand transplant recipients is largely the same as standard-of-care following hand replantation (re-attachment) and peripheral nerve repairs. This involves an eclectic combination of traditional therapies. In seeking to improve on this approach, there is potentially much to be gained by considering evidence that limb amputation not only impacts the peripheral nervous system but also the brain, and tailoring interventions accordingly.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 347 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Harnessing Neuroplasticity to Enhance Functional Recovery in Allogeneic Hand Transplant and Heterotopic Hand Replant Recipients
Actual Study Start Date : August 15, 2018
Estimated Primary Completion Date : September 14, 2020
Estimated Study Completion Date : September 14, 2020

Arm Intervention/treatment
Active Comparator: Transplantation/Replantation Patients
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)?
Device: Transcranial Direct Current Stimulation
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.
Other Name: tDCS

Behavioral: Modified Constraint Induced Movement Therapy
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.
Other Name: CIMT

Active Comparator: Nerve Injury Patients active
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)?
Device: Transcranial Direct Current Stimulation
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.
Other Name: tDCS

Behavioral: Modified Constraint Induced Movement Therapy
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.
Other Name: CIMT

No Intervention: Actigraphy Testing
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.



Primary Outcome Measures :
  1. Change from Baseline Dellon Modified Moberg Pick-Up Test performance at two weeks. [ Time Frame: Baseline, immediately after end of intervention (+/- 3 days). ]
    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.


Secondary Outcome Measures :
  1. Change from Baseline Action Research Arm Test (ARAT) performance at two weeks. [ Time Frame: Baseline, immediately after end of intervention (+/- 3 days). ]
    The Action Research Arm Test (ARAT) measures limb function by having participants pick up various objects of different sizes, different weights, and different shapes (e.g., a glass of water, a cricket ball). This secondary outcome measure will investigate any change in participant performance between pre- and post-intervention sessions of the ARAT.

  2. Change from baseline upper limb movement as measured by actigraphy-derived variables during everyday life at periodic intervals after intervention. [ Time Frame: Baseline, post intervention at week 1, post intervention at 1 month, post intervention at 3 months, post intervention at 6 months. ]

    This secondary outcome measure will employ actigraphy on participants to measure limb movement in everyday life before and after the intervention. Participants will wear wrist-watch like devices that contain accelerometers on each upper extremity in 24-72 hour sessions. Two primary variables will quantify upper limb activity from accelerometer data: the Bilateral Magnitude and the Magnitude Ratio. The Bilateral Magnitude quantifies the intensity of activity across both limbs, whereas the Magnitude Ratio quantifies the contribution of each limb to activity.

    This outcome measure will investigate the change in the Bilateral Magnitude and Magnitude Ratio between a baseline pre-intervention test and post-intervention actigraphy sessions performed within one week of completion of the intervention, at 1 month post-intervention, 3-months post intervention, and 6-months post intervention.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03610763


Contacts
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Contact: Scott H Frey, Ph.D., Ed.M. 573-882-4572 freylab@missouri.edu

Locations
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United States, Kentucky
Christine Kleinert Institute for Hand & Microsurgery Recruiting
Louisville, Kentucky, United States, 40202
Contact: Christina Kaufman, Ph.D.    502-562-0390    ckaufman@cmki.org   
United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65211
Contact: Scott H Frey, Ph.D., Ed.M.    573-882-4572    freylab@missouri.edu   
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Amy Moore, MD    314-454-4894    mooream@wustl.edu   
Sponsors and Collaborators
University of Missouri-Columbia
Washington University School of Medicine
Christine M. Kleinert Institute for Hand and Microsurgery
Investigators
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Principal Investigator: Scott H Frey, Ph.D., Ed.M. University of Missouri-Columbia
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Responsible Party: Scott H Frey, PhD, Miller Family Professor of Cognitive Neuroscience, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03610763    
Other Study ID Numbers: 2008784
CDMRP-MR141043 ( Other Grant/Funding Number: Army Medical Research & Materiel Command )
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Scott H Frey, PhD, University of Missouri-Columbia:
Rehabilitation Neuroscience
Transcranial Direct Current Stimulation
Rehabilitation Therapy
Neuroplasticity
Transplantation
Hand Therapy
Constraint Induced Movement Therapy
Peripheral Nerve Injuries
tDCS
CIMT
Additional relevant MeSH terms:
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Peripheral Nerve Injuries
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries