Status:
ACTIVE_NOT_RECRUITING
Rehabilitation and Cortical Remodeling After Surgical Intervention for Spinal Cord Injury
Lead Sponsor:
Burke Medical Research Institute
Collaborating Sponsors:
Massachusetts General Hospital
Conditions:
Spinal Cord Injuries
Tetraplegia
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
The aim of this study is to determine the effects of rehabilitation on dexterous hand movements and cortical motor map changes in tetraplegic patients following nerve transfer surgery. The working hyp...
Detailed Description
The recovery of hand and arm function is of critical importance for decreasing long-term care costs and increasing quality of life for individuals with tetraplegia due to spinal cord injury (SCI). A s...
Eligibility Criteria
Inclusion
- Tetraplegia (cervical lesion) with some degree of motor dysfunction in the hand
- Motor incomplete or complete lesion (measured by the ASIA Impairment Scale, A, B, C, D).
- Chronic lesion (at least 6months after the injury)
- Demonstrate stability of motor examination for at least six months.
- Retain intact innervation within paralyzed target muscles (axon recipient) as determined by electrodiagnostics.
- Have muscles innervated by the nerves to be used for the transfers (axon donors) of MRC grade 4/5 or greater and sufficient innervation as determined by electrodiagnostics.
- Have access to an at home caregiver who can assist with customary postsurgical physical therapy.
- Ability to give informed consent and understand the tasks involved.
Exclusion
- Presence of potential risk factor for brain stimulation: history of seizures, presence of surgically implanted foreign bodies such as a pacemaker, metal plate in the skull, and metal inside the skull.
- History of head trauma and/or cognitive deficit
- Medically unstable
- Contraindicated for nerve transfer surgery.
Key Trial Info
Start Date :
July 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04041063
Start Date
July 26 2019
End Date
December 31 2026
Last Update
August 23 2024
Active Locations (1)
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1
Burke Neurological Institute
White Plains, New York, United States, 10605