Rehabilitation and Cortical Remodeling After Surgical Intervention for Spinal Cord Injury

Running, not enrolling · Phase 2

Conditions studied: Spinal Cord Injuries, Tetraplegia, Cervical Spinal Cord Injury

In brief

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 hypothesis is that robot-assisted, intensive rehabilitation will support the return of hand and arm function and strengthen the cortical representations of targeted muscles. The investigators will assess this through TMS mapping and clinical measures of hand and arm function.

Key facts

Study ID

NCT04041063

Run by

Burke Medical Research Institute

People needed

6

Starts

2019-07-26

Expected to finish

2026-12-31

Last updated by the study team

2024-08-23

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Burke Neurological Institute — White Plains, New York, United States

Full record on ClinicalTrials.gov

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