Nerve Transfer After Spinal Cord Injuries

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Washington University School of Medicine
Department of Defense
Information provided by (Responsible Party):
Washington University School of Medicine Identifier:
First received: October 22, 2012
Last updated: November 3, 2015
Last verified: November 2015
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:

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

  • 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 hand held dynamometry

Secondary Outcome Measures:
  • Change in Disabilities of Arm, Shoulder, and Hand (DASH) scores [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The change in MHQ will be followed over time and assessed pre-operatively, 6, 12, 18 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)

  • Rate of reoperation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Hand Function, measured by the Sollerman Hand Function Test [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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

Estimated Enrollment: 20
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)
Arms Assigned Interventions
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.

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.


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

Inclusion Criteria:

  1. 18-65 years of age
  2. Informed Consent Document (ICD) signed by patient
  3. Cervical spinal cord injury resulting in arm & hand functional impairment, with at least preserved elbow function
  4. International Classification of Surgery of the Hand in Tetraplegia (ICSHT) category 0 - 4
  5. Patients with a stable American Spinal Injury Association (ASIA) grade of A, B, or C, showing no evidence of functional improvement in motor examination after at least 6 months of non-operative therapy post-injury
  6. Appropriate candidate for nerve transfer study
  7. Willing and able to comply with the study protocol
  8. < 48 months from injury

Exclusion Criteria:

  1. Active infection at the operative site or systemic infection
  2. Any return or ongoing clinical recovery of distal motor function within 6 months after injury
  3. Physically or mentally compromised
  4. Currently undergoing long-term steroid therapy
  5. Significant joint contractures and/or limitations in passive range of motion in the arm or hand
  6. Active malignancy
  7. Systemic disease that would affect the patient's welfare or the research study
  8. Pregnant
  9. Immunologically suppressed or immunocompromised
  10. Significant pain or hypersensitivity
  11. Previous or current injury preventing use of tendon transfers to restore upper extremity function
  12. Affective disorder of a degree that would make outcome assessment and study participation difficult
  13. History of brachial plexus injury or systemic neuropathic process
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01714349

Contact: Wilson Ray, MD 314-362-3577
Contact: Alaina Landstrom, BSN, RN 314-362-3114

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

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine Identifier: NCT01714349     History of Changes
Other Study ID Numbers: NTSCI
Study First Received: October 22, 2012
Last Updated: November 3, 2015
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries processed this record on November 27, 2015