Restoring Hand Function Utilizing Nerve Transfers in Persons With Cervical Spinal Cord Injuries

The University of Texas Health Science Center, Houston1 site in 1 country3 target enrollmentApril 1, 2018

ConditionsCervical Spinal Cord Injury Spinal Cord Injuries Traumatic Spinal Cord Compression

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cervical Spinal Cord Injury
Sponsor: The University of Texas Health Science Center, Houston
Enrollment: 3
Locations: 1
Primary Endpoint: Upper extremity muscle strength of left arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to evaluate the safety and efficacy of nerve transfer surgery for restoring hand function as a therapy for patients with cervical spinal cord injury.

Registry

clinicaltrials.gov

Start Date

April 1, 2018

End Date

July 17, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

The University of Texas Health Science Center, Houston

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•American Spinal Injury Association (ASIA) grade of A, B, or C, or with a diagnosis of central cord syndrome, showing minimal to no evidence of functional improvement in motor examination after at least 6 months of non-operative therapy post-injury
•\>6 months post-injury
•International Classification of Surgery of the Hand in Tetraplegia (ICSHT) category 0-4
•Cervical spinal cord injury resulting in arm \& hand functional impairment, with at least preserved elbow flexion
•Physically and mentally willing and able to comply with study protocol
•Lives in the immediate area and has no plans to relocate
•Provides informed consent and HIPAA release of medical information

Exclusion Criteria

•Active infection
•Any return or ongoing clinical recovery of distal motor function within 6 months after injury
•Physically/mentally compromised
•Systemic disease that would affect the patient's welfare or the research study
•Immunologically suppressed or immunocompromised
•Currently undergoing long-term steroid therapy
•Active malignancy
•Pending litigation or receiving Workers Compensation related to injury or accident
•Pregnancy
•Significant contractures and/or limitations in passive range of motion in the arm or hand

Outcomes

Primary Outcomes

Upper extremity muscle strength of left arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale

Time Frame: post-operative at 24 months

The GRASSP is a measure of upper extremity strength, sensation, and grip that is specific to patients with tetraplegia. It consists of 5 subscales for each upper extremity, and this measure will report the strength subscale (manual muscle testing of 10 muscles in right arm - subscale total score encompasses all 10 muscles). The strength subscale total score ranges from 0 to 50. The GRASSP will be administered by the nurses or physical therapist involved in the study.

Upper extremity muscle strength of right arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale

Time Frame: post-operative at 24 months

e GRASSP is a measure of upper extremity strength, sensation, and grip that is specific to patients with tetraplegia. It consists of 5 subscales for each upper extremity, and this measure will report the strength subscale (manual muscle testing of 10 muscles in right arm - subscale total score encompasses all 10 muscles). The strength subscale total score ranges from 0 to 50. The GRASSP will be administered by the nurses or physical therapist involved in the study.

Secondary Outcomes

Strength as assessed by Hand Held Dynamometry (HHD)(Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
Strength as assessed by Manual Muscle Testing (MMT)(Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
Total Score on the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) scale(Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
Function (mobility) as assessed by the Spinal Cord Independence Measure III Self Report (SCIM III SR) questionnaire(Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
Function as assessed total score on the Spinal Cord Independence Measure III Self Report (SCIM III SR) questionnaire(Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
Hand function as assessed by the Michigan Hand Questionnaire (MHQ) total score(Pre-operative, post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
Motor neuron signaling as assessed by electromyography (EMG)(Pre-operative, post-operative at 6 months, 1 year, and 2 years)
Function (self-care) as assessed by the Spinal Cord Independence Measure III Self Report (SCIM III SR) questionnaire(Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
Number of participants who receive the nerve transfer intervention soon after their spinal cord injury(at the time of the nerve transfer intervention)
Number of participants with an improvement in hand function as determined by qualitative video analysis(Pre-operative, post-operative at 6, 12, and 24 months)
Strength as assessed by the American Spinal Injury Association (ASIA) Upper Extremity Motor Score (UEMS)(Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
Dorsal sensation as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) dorsal sensation subscale(Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
Hand function as assessed by the Sollerman Hand Function Test total score(Pre-operative, post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
Disability as assessed by the Disabilities of the Arm, Shoulder, and Hand (DASH) instrument total score(Pre-operative, post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
Health-related Quality of Life as assessed by the Short Form 36 (SF-36) questionnaire total score(Pre-operative, post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
Number of participants with intraoperative complications(24 months)
Number of participants who require reoperation(24 months)
Palmar sensation as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) palmar sensation subscale(Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
Qualitative grasp as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) qualitative grasp subscale(Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
Quantitative grasp as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) quantitative grasp subscale(Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
Function (respiration and sphincter management) as assessed by the Spinal Cord Independence Measure III Self Report (SCIM III SR) questionnaire(Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
Number of participants with post-operative complications(24 months)