Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nerve Transfer After Spinal Cord Injury- Multi-center

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: NCT04023591
Recruitment Status : Not yet recruiting
First Posted : July 17, 2019
Last Update Posted : September 17, 2019
Sponsor:
Collaborators:
The University of Texas Health Science Center, Houston
Stanford University
University of Pennsylvania
University of Michigan
University of Calgary
University of Utah
United States Department of Defense
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
Current treatment strategies of acute cervical spinal cord injuries remain limited. Treatment options that provide meaningful improvements in patient quality of like 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 spinal cord injuries with no hand function. Optimize the efficiency of nerve transfer surgery by evaluating patient outcomes in relation to patient selection and liffe and functional independence.

Condition or disease Intervention/treatment Phase
Tetraplegia Spinal Cord Injuries Quadriplegia Flaccid Procedure: Surgery/Occupational Therapy Not Applicable

Detailed Description:

Study Design and Feasibility: A prospective multi-institutional non-randomized single arm design will be utilized. Seventy subjects with cervical ASIA A-B (International Standards for Neurological Classification of Spinal Cord Injury) SCI and hand function impairment that fit the International Classification for Surgery of the Hand 0-4 will be identified. Only patients with stable ASIA scores and no evidence of functional improvement in motor or sensory examination for at least 3 months will be recruited. All patients will undergo Electromyography (EMG) and nerve conduction studies (NCS) to verify intact innervation (normal compound muscle action potentials (CMAPs)) to the paralyzed target muscles below the level of injury. Functional electrical stimulation (FES) will be used to verify loss of lower motor neuron function in key muscle groups in the zone of injury and help differentiate those muscle with intact connections to preserve anterior horn cells. Only those patients with clinically normal, Medical Research Council (MRC) muscle grade 5/5 donor (axonal donor) function will be enrolled.

Outcome Measures Primary Outcome Measures: Pre- and Post-operative upper motor strength. (Manual motor testing & Hand Held Dynamometry) Secondary Outcome Measures: Disabilities of the Arm, Shoulder, and Hand (DASH), Michigan Hand Questionnaire (MHQ), Spinal Cord Injury Quality of Life (SCIQOL), GRASSP test (pre-operative, post-operatively - 6 months, 12 months, and 24 months, 36 months and 48 months), rates of intraoperative and post-operative complications, and rates of reoperation.

Rehabilitation and hand therapy are critical components of motor re-education following nerve transfers. Cortical plasticity and motor remapping occurs following nerve transfers allowing independent functional control of the recipient muscles. All patients will begin rehabilitation and hand therapy beginning 2 weeks after surgery. They undergo one hour of hand therapy and occupational therapy for motor re-education once to twice a week for 48 months following surgery. Rehabilitation will be phased to early and late - added exercises focusing on co-contraction, repetition, and range of motion will be included as home therapy.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nerve Transfers to Improve Upper Extremity Function and Quality of Life in Tetraplegic Patients
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : March 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Surgery
Surgery/ Occupational Therapy
Procedure: Surgery/Occupational Therapy
Surgery based on function and injury/ Occupational therapy for 48 months post-surgery




Primary Outcome Measures :
  1. Manual Motor Testing [ Time Frame: 48 months ]
    Change from baseline testing strength of upper extremities at 48 months post-operatively

  2. Handheld Dynamometry [ Time Frame: 48 months ]
    Change from baseline grip strength at 48 months post-operatively


Secondary Outcome Measures :
  1. Change in Disabilities of Arm, Shoulder and Hand (DASH) scores [ Time Frame: 48 months ]
    Change from baseline DASH scores at 48 months post-operatively. Scores range from 0-100 with 0 being the most positive score representing no arm, shoulder or hand disability and 100 being the lowest score indicating the most severe arm, shoulder and hand disability.

  2. Change in Spinal Cord Injury Quality of Life (SCIQOL) scores [ Time Frame: 48 months ]
    Change in baseline SCIQOL scores at 48 months post-operatively. Five scores of 0-30 (0=less satisfied and 30=most satisfied) are calculated: 1. Total Quality of Life; 2. Health and Functioning Subscale; 3. Social and Economic Subscale; 4. Psychological/Spiritual Subscale; 5 Family Subscale. Calculation of scores weighs satisfaction scores according to level of importance assigned to each item. An overall score can be obtained by summing the scores for all six scales after reversing the pain scale and dividing by six.

  3. Change in Michigan Hand Questionnaire Scores [ Time Frame: 48 months ]
    Change in baseline MHQ scores at 48 months post-operatively. Six domains: overall hand function; 2. activities of daily living; 3. work performance; 4. pain; 5. aesthetics; 6. satisfaction. Raw scale for each of the six scales is converted to a score ranging from 0-100 (0=no pain/better hand performance; 100 = is most pain/worst hand performance)

  4. Rates of Intra-operative and post-operative complications [ Time Frame: 48 months ]
    The number of complications within and after the operation

  5. Hand Function, measured by the GRASSP test [ Time Frame: 48 months ]
    Change in baseline GRASSP Test results for hand function at 48 months post-operatively

  6. Changes in the Graded Redefined Assessment of Strength, Sensation and Prehension scores (GRASSP) [ Time Frame: 48 months ]
    Change in baseline GRASSP results for strength, sensation and prehension at 48 months post-operatively. Five subtests: 1. Dorsal sensation (3 locations) each scored 0-4 (sum =subtest score, 0-12, with 0 being no sensation and 12 being normal sensation); 2. Palmar sensation (same as above); 3. Strength (10 muscles of arms and hand), motor grad 0-5 for each (sum = subtest total 0-50 with 0 being worst score and 50 being full motor function in all muscles); 4. Prehension ability - 3 grasps (cylindrical, lateral key, tip to tip) - each scored 0-4 (sum=subtest score, 0-12 with 0 being worst function and 12 being no dysfunction); 5 Prehension performance - 6 prehension tasks (pour water, open jars, pick up and turn key, transfer 9 pegs from board, pick up four coins and place in slot and screw 4 nuts on bolt - each scored 0-5 (sum=subtest score 0-30 with 0 being worst score to 30 being best possible score.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Age 18-65, inclusive
  2. At least 3 months of non-operative rehab therapy
  3. Mentally and physically willing and able to comply with evaluations
  4. Less than 36 months post-injury
  5. Stable ASIA scores with no evidence of functional improvement in motor or sensory examination for at least 3 months
  6. ASIA A or B determined by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
  7. EMG/NCS verifies intact innervation (normal CMAPs) to the paralyzed target muscles below the level of injury
  8. Functional electrical stimulation (FES) will be performed. Subject must have clinically normal MRC grade 5/5 donor (axonal) function

Exclusion Criteria

  1. Active infection at the operative site or systemic infection
  2. Any return or ongoing clinical recovery of distal motor function
  3. Mentally or physically compromised that will prevent them from complying with evaluations.
  4. Immunologically suppressed
  5. Currently undergoing long-term steroid therapy
  6. Active malignancy
  7. Pregnant
  8. Significant joint contractures and/or limitations in passive range of motion in the arm or hand, per treating surgeon's discretion
  9. Lack of appropriate social support and/or infrastructure to commit to scheduled follow-up visits.
  10. Patients who are planning on undergoing a tendon transfer during the study period.

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 ClinicalTrials.gov identifier (NCT number): NCT04023591


Contacts
Layout table for location contacts
Contact: Linda A Koester, BS 314-362-7368 koesterl@wustl.edu
Contact: Aubrey Wright, AS 314-362-3114 wrightau@wustl.edu

Locations
Layout table for location information
United States, California
Stanford University Not yet recruiting
Stanford, California, United States, 94305
Contact: Thomas J Wilson, MD    650-723-0320    wilsontj@stanford.edu   
Principal Investigator: Thomas J Wilson, MD         
United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Karen Sagher    734-232-4843    kfrisch@med.umich.edu   
Principal Investigator: Linda Yang, MD         
United States, Missouri
Washington University Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: Linda Koester, BS    314-362-7368    koesterl@wustl.edu   
Contact: Aubrey Wright, AS    314-362-3114    wrightau@wustl.edu   
Sub-Investigator: Neringa Juknis, MD         
United States, Pennsylvania
University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Eileen Maloney    215-662-6462    Eileen.Maloney@pennmedicine.upenn.edu   
Contact: Olivia Amendolia, MSN    215-615-5436      
Principal Investigator: Eric Zager, MD         
United States, Texas
The University of Texas Houston Health Science Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Rebecca Martinez, BSN    713-500-6141    rebecca.martinez@uth.tmc.edu   
Principal Investigator: Wesley Jones, MD         
United States, Utah
University of Utah Not yet recruiting
Salt Lake City, Utah, United States, 84132
Contact: Andrea Strauss    801-587-2924    andrea.strauss@hsc.utah.edu   
Principal Investigator: Mark Mahan, MD         
Canada, Alberta
Alberta Health Services - Foothills Medical Center Not yet recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Ish Bains    403-944-4334    Ish.Bains@albertahealthservices.ca   
Principal Investigator: Rajiv Midha, MD         
Sponsors and Collaborators
Washington University School of Medicine
The University of Texas Health Science Center, Houston
Stanford University
University of Pennsylvania
University of Michigan
University of Calgary
University of Utah
United States Department of Defense
Investigators
Layout table for investigator information
Principal Investigator: Wilson Z Ray, MD Washington University School of Medicine

Additional Information:
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04023591     History of Changes
Other Study ID Numbers: SC180063
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share individual participant data. Only aggregate data will be published.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Washington University School of Medicine:
tetraplegia
spinal cord injury
quadriplegia
nerve transfer
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Quadriplegia
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Paralysis
Neurologic Manifestations
Signs and Symptoms