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Nerve Transfers for Spinal Cord Injuries

This study is currently recruiting participants.
Verified December 2012 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01714349
First received: October 22, 2012
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention
Spinal Cord Injury
 Procedure: Nerve Transfer

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Restoring Hand Function Using Nerve Transfers in Persons With Spinal Cord Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Change in upper motor strength [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Patients motor strength will be assessed over 24 months of clinical follow-up with conventional manual motor testing


Secondary Outcome Measures:
  • Change in Disabilities of Arm, Shoulder, and Hand (DASH) scores [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Pre-operative, 3, 6, 12, and 24 month

  • Change in Short Form 36 (SF-36) scores [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The change in SF-36 scores will be followed over time and assessed pre-operatively, 3,6,12, and 24 months post-operatively.


Other Outcome Measures:
  • Rates of Intraoperative and Post-operative complications [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Effect of timing on surgical intervention [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Assess the effect of timing on primary and secondary outcome measures, early (<12 months) vs. (>12 months)


Estimated Enrollment: 20
Study Start Date: October 2012
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nerve Transfer
Surgical - Nerve transfers for patients with stable cervical spinal cord injuries
 Procedure: Nerve Transfer
A single nerve transfer will be offered to the surgical group, the brachialis branch to the anterior interosseous nerve.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cervical spinal cord injury ASIA A-B resulting in hand functional impairment
  • No evidence of clinical recovery with at least 6 months of non-operative therapy
  • Normal elbow and shoulder strength and range of motion
  • 18-65 years of age
  • Physically and mentally willing to comply with post-operative therapy and evaluations
  • Lives in the immediate area with no plans to relocate

Exclusion Criteria:

  • Associated brachial plexus injury
  • Associated moderate to severe head injury
  • Fractures in the upper extremities, joint instability or joint contractors
  • Significant pain or hypersensitivity
  • Active local or systemic infection
  • Active malignancy
  • Pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01714349

Contacts
Contact: Wilson Ray, MD 314-362-3577 rayz@wudosis.wustl.edu
Contact: William Janes, OTD, MSCI 314-289-4270 janesw@wusm.wustl.edu

Locations
United States, Missouri
Washington University Recruiting
St. Louis, Missouri, United States, 63110
Contact: William Janes, OTD, MSCI     314-289-4270     janesw@wusm.wustl.edu    
Principal Investigator: Wilson Ray, MD            
Sub-Investigator: Jack Engsberg, PhD            
Sub-Investigator: William Janes, OTD, MSCI            
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Wilson Z Ray, MD Washington University, St. Louis
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01714349     History of Changes
Other Study ID Numbers: NTSCI
Study First Received: October 22, 2012
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Spinal cord injury
nerve transfer
tetraplegia

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013