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

Peripheral Nerve Injuries Clinical Trial

Official title:

Harnessing Neuroplasticity to Enhance Functional Recovery in Allogeneic Hand Transplant and Heterotopic Hand Replant Recipients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03610763
• Other study ID #: 2008784
• Secondary ID: CDMRP-MR141043
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2018
• Est. completion date: June 1, 2025

Study information

• Verified date: June 2024
• Source: University of Missouri-Columbia
• Contact: Scott H Frey, Ph.D., Ed.M.
• Phone: 573-882-4572
• Email: freylab[@]missouri.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hand Transplantation
• Neurologic Rehabilitation
• Peripheral Nerve Injuries

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri
United States	Christine Kleinert Institute for Hand & Microsurgery	Louisville	Kentucky
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
University of Missouri-Columbia	Christine M. Kleinert Institute for Hand and Microsurgery, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from Baseline Action Research Arm Test (ARAT) performance at two weeks.	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.	Baseline, immediately after end of intervention (+/- 3 days).
Secondary	Change from baseline upper limb movement as measured by actigraphy-derived variables during everyday life at periodic intervals after intervention.	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.	Baseline, post intervention at week 1, post intervention at 1 month, post intervention at 3 months, post intervention at 6 months.