Trial record 1 of 1 for:    NCT01714349
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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. Identifier: NCT01714349
Recruitment Status : Recruiting
First Posted : October 25, 2012
Last Update Posted : November 6, 2017
United States Department of Defense
Information provided by (Responsible Party):
Washington University School of Medicine

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

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Procedure: Nerve Transfer Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Study Start Date : October 2012
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Other Outcome Measures:
  1. Rates of Intraoperative and Post-operative complications [ Time Frame: 24 months ]
    The number of complications within and after the operation.

  2. 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)

  3. Rate of reoperation [ Time Frame: 24 months ]
    The rate at which a patient needs to be operated on again.

  4. 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

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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, 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
  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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01714349

Contact: Wilson Ray, MD 314-362-3577

United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Aubrey Wright    314-362-3114   
Contact: Ellen Carlson, BSN,RN    314-747-6560   
Principal Investigator: Wilson Z Ray, MD         
Sub-Investigator: Jack Engsberg, PhD         
Sub-Investigator: Daniel Osei, MD         
Sub-Investigator: Neringa Juknis, MD         
Sponsors and Collaborators
Washington University School of Medicine
United States Department of Defense
Principal Investigator: Wilson Z Ray, MD Washington University School of Medicine

Additional Information:
Responsible Party: Washington University School of Medicine Identifier: NCT01714349     History of Changes
Other Study ID Numbers: NTSCI
First Posted: October 25, 2012    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

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

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