NCT03610763|RecruitingFDA Device
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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Army Medical Research & Materiel Command
interventional
180
1 country
3
Study Start
August 15, 2018
Actual (reported)Primary Completion
June 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 23, 2018
Actual (reported)August 1, 2018
Actual (reported)August 15, 2018
Actual (reported)June 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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).
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.
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)?
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)?
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.
Christine Kleinert Institute for Hand & Microsurgery
Louisville, Kentucky, 40202, United States
University of Missouri
Columbia, Missouri, 65211, United States
Scott H Frey, Ph.D., Ed.M.
University of Missouri-Columbia
First Submitted
June 23, 2018
First Posted
August 1, 2018
Study Start
August 15, 2018
Actual (reported)Primary Completion
June 1, 2025
Estimated (date passed)Transcranial Direct Current Stimulation (tDCS) in Post-Stroke Working Memory Deficits
Baseline, post intervention at week 1, post intervention at 1 month, post intervention at 3 months, post intervention at 6 months.
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.
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.
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 12, 2024
Record last verified: 2024-06
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Source: ClinicalTrials.gov.
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