Clinical trial NCT03451474: Restoring Hand Function Utilizing Nerve Transfers in Persons With Cervical Spinal Cord Injuries
Official title: Restoring Hand Function Utilizing Nerve Transfers in Persons With Cervical Spinal Cord Injuries
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cervical Spinal Cord Injury
Spinal Cord Injuries
Traumatic Spinal Cord Compression
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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
* Poorly controlled upper extremity spasticity
* Uncontrolled pain or hypersensitivity
* Previous or current injury preventing use of tendon transfers to restore upper extremity function
* History of brachial plexus injury or systemic neuropathic process
* In the opinion of the Principal Investigator the subject would not be a candidate for the procedure

Primary outcomes:
measure: Upper extremity muscle strength of right arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale
timeFrame: Pre-operative
measure: Upper extremity muscle strength of right arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale
timeFrame: post-operative at 2 weeks
measure: Upper extremity muscle strength of right arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale
timeFrame: post-operative at 3 months
measure: Upper extremity muscle strength of right arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale
timeFrame: post-operative at 6 months
measure: Upper extremity muscle strength of right arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale
timeFrame: post-operative at 12 months
measure: Upper extremity muscle strength of right arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale
timeFrame: post-operative at 24 months
measure: Upper extremity muscle strength of left arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale
timeFrame: Pre-operative
measure: Upper extremity muscle strength of left arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale
timeFrame: post-operative at 2 weeks
measure: Upper extremity muscle strength of left arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale
timeFrame: post-operative at 3 months
measure: Upper extremity muscle strength of left arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale
timeFrame: post-operative at 6 months
measure: Upper extremity muscle strength of left arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale
timeFrame: post-operative at 12 months
measure: Upper extremity muscle strength of left arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale
timeFrame: post-operative at 24 months
Secondary outcomes:
measure: Motor neuron signaling as assessed by electromyography (EMG)
timeFrame: Pre-operative, post-operative at 6 months, 1 year, and 2 years
measure: Strength as assessed by Manual Muscle Testing (MMT)
timeFrame: Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months
measure: Strength as assessed by Hand Held Dynamometry (HHD)
timeFrame: Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months
measure: Strength as assessed by the American Spinal Injury Association (ASIA) Upper Extremity Motor Score (UEMS)
timeFrame: Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months
measure: Dorsal sensation as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) dorsal sensation subscale
timeFrame: Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months
measure: Palmar sensation as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) palmar sensation subscale
timeFrame: Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months
measure: Qualitative grasp as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) qualitative grasp subscale
timeFrame: Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months
measure: Quantitative grasp as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) quantitative grasp subscale
timeFrame: Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months
measure: Total Score on the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) scale
timeFrame: Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months
measure: Function (self-care) as assessed by the Spinal Cord Independence Measure III Self Report (SCIM III SR) questionnaire
timeFrame: Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months
measure: Function (respiration and sphincter management) as assessed by the Spinal Cord Independence Measure III Self Report (SCIM III SR) questionnaire
timeFrame: Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months
measure: Function (mobility) as assessed by the Spinal Cord Independence Measure III Self Report (SCIM III SR) questionnaire
timeFrame: Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months
measure: Function as assessed total score on the Spinal Cord Independence Measure III Self Report (SCIM III SR) questionnaire
timeFrame: Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months
measure: Hand function as assessed by the Michigan Hand Questionnaire (MHQ) total score
timeFrame: Pre-operative, post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months
measure: Hand function as assessed by the Sollerman Hand Function Test total score
timeFrame: Pre-operative, post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months
measure: Disability as assessed by the Disabilities of the Arm, Shoulder, and Hand (DASH) instrument total score
timeFrame: Pre-operative, post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months
measure: Health-related Quality of Life as assessed by the Short Form 36 (SF-36) questionnaire total score
timeFrame: Pre-operative, post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months
measure: Number of participants with intraoperative complications
timeFrame: 24 months
measure: Number of participants with post-operative complications
timeFrame: 24 months
measure: Number of participants who require reoperation
timeFrame: 24 months
measure: Number of participants who receive the nerve transfer intervention soon after their spinal cord injury
timeFrame: at the time of the nerve transfer intervention
measure: Number of participants with an improvement in hand function as determined by qualitative video analysis
timeFrame: Pre-operative, post-operative at 6, 12, and 24 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Wesley H Jones, MD
role: PRINCIPAL_INVESTIGATOR
References: