Nerve Transfer After Spinal Cord Injuries
|Study Design:||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|
- Change in upper motor strength [ Time Frame: 24 months ]Patients motor strength will be assessed over 24 months of clinical follow-up with conventional manual motor testing
- Change in upper motor strength [ Time Frame: 24 months ]Patients motor strength will be assessed over 24 months of clinical follow-up with hand held dynamometry
- Change in Disabilities of Arm, Shoulder, and Hand (DASH) scores [ Time Frame: 24 months ]The change in DASH scores will be followed over time and assessed pre-operatively, 6,12, 18, and 24 months post-operatively.
- Change in Short Form 36 (SF-36) scores [ Time Frame: 24 months ]The change in SF-36 scores will be followed over time and assessed pre-operatively, 6, 12, 18, and 24 months post-operatively.
- Change in Michigan Hand Questionnaire (MHQ) [ Time Frame: 24 months ]The change in MHQ will be followed over time and assessed pre-operatively, 6, 12, 18 and 24 months post-operatively.
- Rates of Intraoperative and Post-operative complications [ Time Frame: 24 months ]
- Effect of timing on surgical intervention [ Time Frame: 24 months ]Assess the effect of timing on primary and secondary outcome measures, early (<12 months) vs. (>12 months)
- Rate of reoperation [ Time Frame: 24 months ]
- Hand Function, measured by the Sollerman Hand Function Test [ Time Frame: 24 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
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||October 2019|
|Estimated Primary Completion Date:||October 2019 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01714349
|Contact: Wilson Ray, MDfirstname.lastname@example.org|
|United States, Missouri|
|St. Louis, Missouri, United States, 63110|
|Contact: Aubrey Wright 314-362-3114 email@example.com|
|Contact: Ellen Carlson, BSN,RN 314-747-6560 firstname.lastname@example.org|
|Principal Investigator: Wilson Z Ray, MD|
|Sub-Investigator: Jack Engsberg, PhD|
|Sub-Investigator: Daniel Osei, MD|
|Sub-Investigator: Neringa Juknis, MD|
|Principal Investigator:||Wilson Z Ray, MD||Washington University School of Medicine|