- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01714349
Nerve Transfer After Spinal Cord Injuries
Restoring Hand Function Using Nerve Transfers in Persons With Spinal Cord Injury
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
St Louis, Missouri, United States, 63110
- Washington University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 - 4
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nerve Transfer
Surgical - Nerve transfers for patients with stable cervical spinal cord injuries
|
A nerve transfer procedure will be individualized to each patient's functional deficit.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in upper motor strength
Time Frame: 48 months
|
Patients motor strength will be assessed over 48 months of clinical follow-up with conventional manual motor testing
|
48 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Disabilities of Arm, Shoulder, and Hand (DASH) scores
Time Frame: 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.
|
48 months
|
|
Change in Short Form 36 (SF-36) scores
Time Frame: 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.
|
48 months
|
|
Change in Michigan Hand Questionnaire (MHQ)
Time Frame: 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.
|
48 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rates of Intraoperative and Post-operative complications
Time Frame: 48 months
|
The number of complications within and after the operation.
|
48 months
|
|
Effect of timing on surgical intervention
Time Frame: 48 months
|
Assess the effect of timing on primary and secondary outcome measures, early (<12 months) vs. (>12 months)
|
48 months
|
|
Rate of reoperation
Time Frame: 48 months
|
The rate at which a patient needs to be operated on again.
|
48 months
|
|
Hand Function, measured by the Sollerman Hand Function Test
Time Frame: 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
|
48 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Wilson Z Ray, MD, Washington University School of Medicine
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Trauma, Nervous System
- Spinal Cord Diseases
- Paralysis
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Spinal Cord Injuries
- Quadriplegia
- Surgical Procedures, Operative
- Neurosurgical Procedures
- Nerve Transfer
Other Study ID Numbers
- NTSCI -201208137
- CDMRP-SC140051 (Other Identifier: eBRAP log number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.