Nerve Transfer After Spinal Cord Injuries

Sponsor

Washington University School of Medicine (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01714349

Collaborator

United States Department of Defense (U.S. Fed)

Enrollment

Location

Arm

124.9

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Nerve Transfer surgery can provide improved hand function following cervical spinal cord injuries

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injury	Procedure: Nerve Transfer	N/A

Detailed Description

Current treatment strategies of acute cervical spinal cord injuries remain limited. Treatment options that provide meaningful improvements in patient quality of life and long-term functional independence will provide a significant public health impact.

Specific Aim: Measure the efficacy of nerve transfer surgery in the treatment of patients with complete cervical spinal cord injuries with no hand function. Optimize the efficiency of nerve transfer surgery by evaluating patient outcomes in relation to patient selection and optimal timing the the surgery.

Hypothesis: Peripheral nerve transfers in patients with spinal cord injuries will improve hand function and provide improvement in patient quality of life and functional independence.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Restoring Hand Function Using Nerve Transfers in Persons With Spinal Cord Injury

Study Start Date :

Oct 1, 2012

Anticipated Primary Completion Date :

Feb 10, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nerve Transfer Surgical - Nerve transfers for patients with stable cervical spinal cord injuries	Procedure: Nerve Transfer A nerve transfer procedure will be individualized to each patient's functional deficit.

Arm

Intervention/Treatment

Experimental: Nerve Transfer

Surgical - Nerve transfers for patients with stable cervical spinal cord injuries

Procedure: Nerve Transfer

A nerve transfer procedure will be individualized to each patient's functional deficit.

Outcome Measures

Primary Outcome Measures

Change in upper motor strength [48 months]
Patients motor strength will be assessed over 48 months of clinical follow-up with conventional manual motor testing

Secondary Outcome Measures

Change in Disabilities of Arm, Shoulder, and Hand (DASH) scores [48 months]
The change in DASH scores will be followed over time and assessed pre-operatively, 6,12, 18, 24, 36 and 48 months post-operatively.
Change in Short Form 36 (SF-36) scores [48 months]
The change in SF-36 scores will be followed over time and assessed pre-operatively, 6, 12, 18, 24. 36 and 48 months post-operatively.
Change in Michigan Hand Questionnaire (MHQ) [48 months]
The change in MHQ will be followed over time and assessed pre-operatively, 6, 12, 18, 24, 36 and 48 months post-operatively.

Other Outcome Measures

Rates of Intraoperative and Post-operative complications [48 months]
The number of complications within and after the operation.
Effect of timing on surgical intervention [48 months]
Assess the effect of timing on primary and secondary outcome measures, early (<12 months) vs. (>12 months)
Rate of reoperation [48 months]
The rate at which a patient needs to be operated on again.
Hand Function, measured by the Sollerman Hand Function Test [48 months]
The Sollerman Hand Function Test is performed as part of an overall evaluation and assessment by study team Occupational Therapist pre-operatively, post-operatively, and at 6 months, 12 months, 18 months, and 24 months. 36 months and 48 months

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18-65 years of age
Informed Consent Document (ICD) signed by patient
Cervical spinal cord injury resulting in arm & hand functional impairment, with at least preserved elbow function
International Classification of Surgery of the Hand in Tetraplegia (ICSHT) category 0

Patients with a stable 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
Appropriate candidate for nerve transfer study
Willing and able to comply with the study protocol
< 48 months from injury

Exclusion Criteria:

Active infection at the operative site or systemic infection
Any return or ongoing clinical recovery of distal motor function within 6 months after injury
Physically or mentally compromised
Currently undergoing long-term steroid therapy
Significant joint contractures and/or limitations in passive range of motion in the arm or hand
Active malignancy
Systemic disease that would affect the patient's welfare or the research study
Pregnant
Immunologically suppressed or immunocompromised
Significant pain or hypersensitivity
Previous or current injury preventing use of tendon transfers to restore upper extremity function
Affective disorder of a degree that would make outcome assessment and study participation difficult
History of brachial plexus injury or systemic neuropathic process