Nerve Transfer After Spinal Cord Injuries
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01714349|
Recruitment Status : Recruiting
First Posted : October 25, 2012
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Procedure: Nerve Transfer||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Restoring Hand Function Using Nerve Transfers in Persons With Spinal Cord Injury|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
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.
- 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 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 ]The number of complications within and after the operation.
- 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 ]The rate at which a patient needs to be operated on again.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01714349
|Contact: Wilson Ray, MDfirstname.lastname@example.org|
|United States, Missouri|
|Saint 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|