Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01714349
Recruitment Status : Active, not recruiting
First Posted : October 25, 2012
Last Update Posted : July 15, 2019
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE October 22, 2012
First Posted Date  ICMJE October 25, 2012
Last Update Posted Date July 15, 2019
Study Start Date  ICMJE October 2012
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
Change in upper motor strength [ Time Frame: 48 months ]
Patients motor strength will be assessed over 48 months of clinical follow-up with conventional manual motor testing
Original Primary Outcome Measures  ICMJE
 (submitted: October 22, 2012)
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 History Complete list of historical versions of study NCT01714349 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
  • Change in Disabilities of Arm, Shoulder, and Hand (DASH) scores [ Time Frame: 48 months ]
    The change in DASH scores will be followed over time and assessed pre-operatively, 6,12, 18, 24, 36 and 48 months post-operatively.
  • Change in Short Form 36 (SF-36) scores [ Time Frame: 48 months ]
    The change in SF-36 scores will be followed over time and assessed pre-operatively, 6, 12, 18, 24. 36 and 48 months post-operatively.
  • Change in Michigan Hand Questionnaire (MHQ) [ Time Frame: 48 months ]
    The change in MHQ will be followed over time and assessed pre-operatively, 6, 12, 18, 24, 36 and 48 months post-operatively.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2012)
  • Change in Disabilities of Arm, Shoulder, and Hand (DASH) scores [ Time Frame: 24 months ]
    Pre-operative, 3, 6, 12, and 24 month
  • 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, 3,6,12, and 24 months post-operatively.
Current Other Pre-specified Outcome Measures
 (submitted: July 11, 2019)
  • Rates of Intraoperative and Post-operative complications [ Time Frame: 48 months ]
    The number of complications within and after the operation.
  • Effect of timing on surgical intervention [ Time Frame: 48 months ]
    Assess the effect of timing on primary and secondary outcome measures, early (<12 months) vs. (>12 months)
  • Rate of reoperation [ Time Frame: 48 months ]
    The rate at which a patient needs to be operated on again.
  • Hand Function, measured by the Sollerman Hand Function Test [ Time Frame: 48 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. 36 months and 48 months
Original Other Pre-specified Outcome Measures
 (submitted: October 22, 2012)
  • 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)
 
Descriptive Information
Brief Title  ICMJE Nerve Transfer After Spinal Cord Injuries
Official Title  ICMJE Restoring Hand Function Using Nerve Transfers in Persons With Spinal Cord Injury
Brief Summary Nerve Transfer surgery can provide improved hand function following cervical spinal cord injuries
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE Procedure: Nerve Transfer
A nerve transfer procedure will be individualized to each patient's functional deficit.
Study Arms  ICMJE Experimental: Nerve Transfer
Surgical - Nerve transfers for patients with stable cervical spinal cord injuries
Intervention: Procedure: Nerve Transfer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 22, 2012)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01714349
Other Study ID Numbers  ICMJE NTSCI -201208137
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE United States Department of Defense
Investigators  ICMJE
Principal Investigator: Wilson Z Ray, MD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP