Rehabilitation and Cortical Remodeling After Surgical Intervention for Spinal Cord Injury

Phase 2

Active, not recruiting

• Conditions: Spinal Cord Injuries; Tetraplegia; Cervical Spinal Cord Injury

• Registration Number: NCT04041063
• Lead Sponsor: Burke Medical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-7-30
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Inclusion Criteria:<br><br> - Tetraplegia (cervical lesion) with some degree of motor dysfunction in the hand<br><br> - Motor incomplete or complete lesion (measured by the ASIA Impairment Scale, A, B, C,<br> D).<br><br> - Chronic lesion (at least 6months after the injury)<br><br> - Demonstrate stability of motor examination for at least six months.<br><br> - Retain intact innervation within paralyzed target muscles (axon recipient) as<br> determined by electrodiagnostics.<br><br> - Have muscles innervated by the nerves to be used for the transfers (axon donors) of<br> MRC grade 4/5 or greater and sufficient innervation as determined by<br> electrodiagnostics.<br><br> - Have access to an at home caregiver who can assist with customary postsurgical<br> physical therapy.<br><br> - Ability to give informed consent and understand the tasks involved.<br><br>Exclusion Criteria:<br><br> - Presence of potential risk factor for brain stimulation: history of seizures,<br> presence of surgically implanted foreign bodies such as a pacemaker, metal plate in<br> the skull, and metal inside the skull.<br><br> - History of head trauma and/or cognitive deficit<br><br> - Medically unstable<br><br> - Contraindicated for nerve transfer surgery.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Box and Blocks test score

Secondary Outcome Measures

Name	Time	Method
Upper extremity motor score (UEMS);Spinal Cord Independence Measure (SCIM III);Modified Ashworth Scale;Single pulse transcranial magnetic stimulation