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Restoring Hand Function Utilizing Nerve Transfers in Persons With Cervical Spinal Cord Injuries

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ClinicalTrials.gov Identifier: NCT03451474
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Daniel Hwan Kim, The University of Texas Health Science Center, Houston

Brief Summary:
The primary objective of this study is to evaluate the safety and efficacy of nerve transfer surgery for restoring hand function as a therapy for patients with cervical spinal cord injury.

Condition or disease Intervention/treatment Phase
Cervical Spinal Cord Injury Spinal Cord Injuries Traumatic Spinal Cord Compression Procedure: Upper extremity nerve transfer surgery Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Restoring Hand Function Utilizing Nerve Transfers in Persons With Cervical Spinal Cord Injuries
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Upper extremity nerve transfer surgery
Upper extremity nerve transfer surgery is a surgical procedure where axons from an intact, functioning upper extremity peripheral nerve are moved to a target muscle that demonstrates significant weakness or paralysis as a result of spinal cord injury. After allowing time for recovery from surgery and for nerve growth to occur, the patient undergoes hand/occupational therapy in order to retrain motor skills.
Procedure: Upper extremity nerve transfer surgery
Upper extremity nerve transfer surgery is a surgical procedure where axons from an intact, functioning upper extremity peripheral nerve are moved to a target muscle that demonstrates significant weakness or paralysis as a result of spinal cord injury. After allowing time for recovery from surgery and for nerve growth to occur, the patient undergoes hand/occupational therapy in order to retrain motor skills.




Primary Outcome Measures :
  1. Upper extremity muscle strength of right arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale [ Time Frame: Pre-operative ]
    The GRASSP is a measure of upper extremity strength, sensation, and grip that is specific to patients with tetraplegia. It consists of 5 subscales for each upper extremity, and this measure will report the strength subscale (manual muscle testing of 10 muscles in right arm - subscale total score encompasses all 10 muscles). The strength subscale total score ranges from 0 to 50. The GRASSP will be administered by the nurses or physical therapist involved in the study.

  2. Upper extremity muscle strength of right arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale [ Time Frame: post-operative at 2 weeks ]
    The GRASSP is a measure of upper extremity strength, sensation, and grip that is specific to patients with tetraplegia. It consists of 5 subscales for each upper extremity, and this measure will report the strength subscale (manual muscle testing of 10 muscles in right arm - subscale total score encompasses all 10 muscles). The strength subscale total score ranges from 0 to 50. The GRASSP will be administered by the nurses or physical therapist involved in the study.

  3. Upper extremity muscle strength of right arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale [ Time Frame: post-operative at 3 months ]
    The GRASSP is a measure of upper extremity strength, sensation, and grip that is specific to patients with tetraplegia. It consists of 5 subscales for each upper extremity, and this measure will report the strength subscale (manual muscle testing of 10 muscles in right arm - subscale total score encompasses all 10 muscles). The strength subscale total score ranges from 0 to 50. The GRASSP will be administered by the nurses or physical therapist involved in the study.

  4. Upper extremity muscle strength of right arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale [ Time Frame: post-operative at 6 months ]
    The GRASSP is a measure of upper extremity strength, sensation, and grip that is specific to patients with tetraplegia. It consists of 5 subscales for each upper extremity, and this measure will report the strength subscale (manual muscle testing of 10 muscles in right arm - subscale total score encompasses all 10 muscles). The strength subscale total score ranges from 0 to 50. The GRASSP will be administered by the nurses or physical therapist involved in the study.

  5. Upper extremity muscle strength of right arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale [ Time Frame: post-operative at 12 months ]
    The GRASSP is a measure of upper extremity strength, sensation, and grip that is specific to patients with tetraplegia. It consists of 5 subscales for each upper extremity, and this measure will report the strength subscale (manual muscle testing of 10 muscles in right arm - subscale total score encompasses all 10 muscles). The strength subscale total score ranges from 0 to 50. The GRASSP will be administered by the nurses or physical therapist involved in the study.

  6. Upper extremity muscle strength of right arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale [ Time Frame: post-operative at 24 months ]
    e GRASSP is a measure of upper extremity strength, sensation, and grip that is specific to patients with tetraplegia. It consists of 5 subscales for each upper extremity, and this measure will report the strength subscale (manual muscle testing of 10 muscles in right arm - subscale total score encompasses all 10 muscles). The strength subscale total score ranges from 0 to 50. The GRASSP will be administered by the nurses or physical therapist involved in the study.

  7. Upper extremity muscle strength of left arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale [ Time Frame: Pre-operative ]
    The GRASSP is a measure of upper extremity strength, sensation, and grip that is specific to patients with tetraplegia. It consists of 5 subscales for each upper extremity, and this measure will report the strength subscale (manual muscle testing of 10 muscles in left arm - subscale total score encompasses all 10 muscles). The strength subscale total score ranges from 0 to 50. The GRASSP will be administered by the nurses or physical therapist involved in the study.

  8. Upper extremity muscle strength of left arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale [ Time Frame: post-operative at 2 weeks ]
    The GRASSP is a measure of upper extremity strength, sensation, and grip that is specific to patients with tetraplegia. It consists of 5 subscales for each upper extremity, and this measure will report the strength subscale (manual muscle testing of 10 muscles in right arm - subscale total score encompasses all 10 muscles). The strength subscale total score ranges from 0 to 50. The GRASSP will be administered by the nurses or physical therapist involved in the study.

  9. Upper extremity muscle strength of left arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale [ Time Frame: post-operative at 3 months ]
    The GRASSP is a measure of upper extremity strength, sensation, and grip that is specific to patients with tetraplegia. It consists of 5 subscales for each upper extremity, and this measure will report the strength subscale (manual muscle testing of 10 muscles in right arm - subscale total score encompasses all 10 muscles). The strength subscale total score ranges from 0 to 50. The GRASSP will be administered by the nurses or physical therapist involved in the study.

  10. Upper extremity muscle strength of left arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale [ Time Frame: post-operative at 6 months ]
    The GRASSP is a measure of upper extremity strength, sensation, and grip that is specific to patients with tetraplegia. It consists of 5 subscales for each upper extremity, and this measure will report the strength subscale (manual muscle testing of 10 muscles in right arm - subscale total score encompasses all 10 muscles). The strength subscale total score ranges from 0 to 50. The GRASSP will be administered by the nurses or physical therapist involved in the study.

  11. Upper extremity muscle strength of left arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale [ Time Frame: post-operative at 12 months ]
    The GRASSP is a measure of upper extremity strength, sensation, and grip that is specific to patients with tetraplegia. It consists of 5 subscales for each upper extremity, and this measure will report the strength subscale (manual muscle testing of 10 muscles in right arm - subscale total score encompasses all 10 muscles). The strength subscale total score ranges from 0 to 50. The GRASSP will be administered by the nurses or physical therapist involved in the study.

  12. Upper extremity muscle strength of left arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale [ Time Frame: post-operative at 24 months ]
    The GRASSP is a measure of upper extremity strength, sensation, and grip that is specific to patients with tetraplegia. It consists of 5 subscales for each upper extremity, and this measure will report the strength subscale (manual muscle testing of 10 muscles in right arm - subscale total score encompasses all 10 muscles). The strength subscale total score ranges from 0 to 50. The GRASSP will be administered by the nurses or physical therapist involved in the study.


Secondary Outcome Measures :
  1. Motor neuron signaling as assessed by electromyography (EMG) [ Time Frame: Pre-operative, post-operative at 6 months, 1 year, and 2 years ]
    Quantitative assessment of motor neuron signalling

  2. Strength as assessed by Manual Muscle Testing (MMT) [ Time Frame: Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months ]
    MMT will be assessed by the physicians, nurses, or physical therapist involved in the study.

  3. Strength as assessed by Hand Held Dynamometry (HHD) [ Time Frame: Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months ]
    Hand held dynamometry (via a "make test") will be used to assess strength.

  4. Strength as assessed by the American Spinal Injury Association (ASIA) Upper Extremity Motor Score (UEMS) [ Time Frame: Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months ]
    The ASIA UEMS is a sum of the motor scores for 5 key upper extremity muscles on both the right and left side (each key muscle is a functionally significant representation of a spinal cord segment). The strength of each key muscle on both the right and left side is graded from 0 to 5, with total scores ranging from 0 to 50.The UEMS will be determined in accordance with the International Standards for Neurological Classification of SCI examination guidelines by the physicians, nurses, or physical therapist.

  5. Dorsal sensation as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) dorsal sensation subscale [ Time Frame: Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months ]
    The GRASSP is a measure of upper extremity strength, sensation, and grip that is specific to patients with tetraplegia. It consists of 5 subscales for each upper extremity: strength (manual muscle testing of 10 muscles in right and left arms - subscale total score encompasses all 10 muscles), dorsal sensation, palmar sensation (measured with Semmes-Weinstein monofilaments), qualitative grasp, and quantitative grasp. Total score (which includes all subscale scores) ranges from 0 to 116 for each upper extremity (right or left arm). The dorsal sensation subscale total score ranges from 0 to 12. The GRASSP will be administered by the nurses or physical therapist involved in the study.

  6. Palmar sensation as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) palmar sensation subscale [ Time Frame: Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months ]
    The GRASSP is a measure of upper extremity strength, sensation, and grip that is specific to patients with tetraplegia. It consists of 5 subscales for each upper extremity: strength (manual muscle testing of 10 muscles in right and left arms - subscale total score encompasses all 10 muscles), dorsal sensation, palmar sensation (measured with Semmes-Weinstein monofilaments), qualitative grasp, and quantitative grasp. Total score (which includes all subscale scores) ranges from 0 to 116 for each upper extremity (right or left arm). The palmar sensation subscale total score ranges from 0 to 12. The GRASSP will be administered by the nurses or physical therapist involved in the study.

  7. Qualitative grasp as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) qualitative grasp subscale [ Time Frame: Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months ]
    The GRASSP is a measure of upper extremity strength, sensation, and grip that is specific to patients with tetraplegia. It consists of 5 subscales for each upper extremity: strength (manual muscle testing of 10 muscles in right and left arms - subscale total score encompasses all 10 muscles), dorsal sensation, palmar sensation (measured with Semmes-Weinstein monofilaments), qualitative grasp, and quantitative grasp. Total score (which includes all subscale scores) ranges from 0 to 116 for each upper extremity (right or left arm). The qualitative grasp subscale total score ranges from 0 to 12. The GRASSP will be administered by the nurses or physical therapist involved in the study.

  8. Quantitative grasp as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) quantitative grasp subscale [ Time Frame: Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months ]
    The GRASSP is a measure of upper extremity strength, sensation, and grip that is specific to patients with tetraplegia. It consists of 5 subscales for each upper extremity: strength (manual muscle testing of 10 muscles in right and left arms - subscale total score encompasses all 10 muscles), dorsal sensation, palmar sensation (measured with Semmes-Weinstein monofilaments), qualitative grasp, and quantitative grasp. Total score (which includes all subscale scores) ranges from 0 to 116 for each upper extremity (right or left arm). The quantitative grasp subscale total score ranges from 0 to 30. The GRASSP will be administered by the nurses or physical therapist involved in the study.

  9. Total Score on the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) scale [ Time Frame: Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months ]
    The GRASSP is a measure of upper extremity strength, sensation, and grip that is specific to patients with tetraplegia. It consists of 5 subscales for each upper extremity: strength (manual muscle testing of 10 muscles in right and left arms - subscale total score encompasses all 10 muscles), dorsal sensation, palmar sensation (measured with Semmes-Weinstein monofilaments), qualitative grasp, and quantitative grasp. Total score (which includes all subscale scores) ranges from 0 to 116 for each upper extremity (right or left arm). The GRASSP will be administered by the nurses or physical therapist involved in the study.

  10. Function (self-care) as assessed by the Spinal Cord Independence Measure III Self Report (SCIM III SR) questionnaire [ Time Frame: Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months ]
    The SCIM III SR is a measure of independence with activities across 3 subscales: self-care, respiration and sphincter management, and mobility. The self-care subscale ranges from 0 to 20.

  11. Function (respiration and sphincter management) as assessed by the Spinal Cord Independence Measure III Self Report (SCIM III SR) questionnaire [ Time Frame: Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months ]
    The SCIM III SR is a measure of independence with activities across 3 subscales: self-care, respiration and sphincter management, and mobility. The respiration and sphincter management subscale ranges from 0 to 40.

  12. Function (mobility) as assessed by the Spinal Cord Independence Measure III Self Report (SCIM III SR) questionnaire [ Time Frame: Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months ]
    The SCIM III SR is a measure of independence with activities across 3 subscales: self-care, respiration and sphincter management, and mobility. The mobility subscale ranges from 0 to 40.

  13. Function as assessed total score on the Spinal Cord Independence Measure III Self Report (SCIM III SR) questionnaire [ Time Frame: Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months ]
    The SCIM III SR is a measure of independence with activities across 3 subscales: self-care, respiration and sphincter management, and mobility. Total score ranges from 0 to 100( that is, the total score is the sum of scores on the three subscales).

  14. Hand function as assessed by the Michigan Hand Questionnaire (MHQ) total score [ Time Frame: Pre-operative, post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months ]
    The MHQ instrument is a 37 core questions, self-report questionnaire used to assess changes in hand function. The MHQ requires subjects to rate their overall hand function, activities of daily living (ADLs), pain, work performance, aesthetics, and patient satisfaction with hand function. Scores on each of the 6 subscales range from 0 to 100, and an overall MHQ score is calculated by averaging the scores of the 6 subscales. The MHQ will be administered by the physicians or nurses involved in the study.

  15. Hand function as assessed by the Sollerman Hand Function Test total score [ Time Frame: Pre-operative, post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months ]
    The Sollerman Hand Function Test is a standardized performance test designed to measure handgrips needed for certain activities of daily living (ADLs), such as eating, driving, personal hygiene, and writing. It includes multiple subtests that represent common handgrips and activities, completed using the hands both bilaterally and separately. Scoring of each subtest takes into account the time taken to complete the task, level of difficulty displayed, and quality of performance using correct grips. Scores range from 0 (task cannot be completed) - 4; a total score (0 - 80) is obtained from the sum of scores of all subtests.

  16. Disability as assessed by the Disabilities of the Arm, Shoulder, and Hand (DASH) instrument total score [ Time Frame: Pre-operative, post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months ]
    The DASH instrument is a 30-item, self-report questionnaire used to assess overall upper extremity function. The DASH requires subjects to rate their ability to perform tasks using the upper extremities. Individuals are instructed to report their ability to perform the tasks, regardless of which arm they use or what strategies they employ. A single disability/symptom score is produced. Scores range from 0-100, where a greater score indicates greater disability. The DASH will be administered by the physicians, nurses, or physical therapist involved in the study.

  17. Health-related Quality of Life as assessed by the Short Form 36 (SF-36) questionnaire total score [ Time Frame: Pre-operative, post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months ]
    The SF-36 is a questionnaire designed to measure general health and quality of life across eight, scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health)--a total score will be reported. The eight subscales are each given scores, which are the weighted sums of the questions in each subscale section, and each subscale score is directly transformed into a total score of 0-100 scale. The lower the score the more disability,a and the higher the score the less disability (that is, a score of zero is equivalent to maximum disability, and a score of 100 is equivalent to no disability). The SF-36 will be administered by the physicians, nurses, or physical therapist involved in the study.

  18. Number of participants with intraoperative complications [ Time Frame: 24 months ]
  19. Number of participants with post-operative complications [ Time Frame: 24 months ]
  20. Number of participants who require reoperation [ Time Frame: 24 months ]
  21. Number of participants who receive the nerve transfer intervention soon after their spinal cord injury [ Time Frame: at the time of the nerve transfer intervention ]
    The nerve transfer intervention will be considered "soon" or "early" if it is less than 12 months after the spinal cord injury that the nerve transfer intervention is intended to treat. This will be assessed at the time of the nerve transfer intervention.

  22. Number of participants with an improvement in hand function as determined by qualitative video analysis [ Time Frame: Pre-operative, post-operative at 6, 12, and 24 months ]


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.


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

Inclusion Criteria:

  • 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 months post-injury
  • International Classification of Surgery of the Hand in Tetraplegia (ICSHT) category 0-4
  • Cervical spinal cord injury resulting in arm & hand functional impairment, with at least preserved elbow flexion
  • Physically and mentally willing and able to comply with study protocol
  • Lives in the immediate area and has no plans to relocate
  • Provides informed consent and HIPAA release of medical information

Exclusion Criteria:

  • Active infection
  • Any return or ongoing clinical recovery of distal motor function within 6 months after injury
  • Physically/mentally compromised
  • Systemic disease that would affect the patient's welfare or the research study
  • Immunologically suppressed or immunocompromised
  • Currently undergoing long-term steroid therapy
  • Active malignancy
  • Pending litigation or receiving Workers Compensation related to injury or accident
  • Pregnancy
  • Significant contractures and/or limitations in passive range of motion in the arm or hand
  • Poorly controlled upper extremity spasticity
  • Uncontrolled pain or hypersensitivity
  • Previous or current injury preventing use of tendon transfers to restore upper extremity function
  • History of brachial plexus injury or systemic neuropathic process
  • In the opinion of the Principal Investigator the subject would not be a candidate for the procedure

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): NCT03451474


Contacts
Contact: Elena Viverette, MS, RN, CCRC 713-500-6936 Elena.E.Viverette@uth.tmc.edu

Locations
United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Elena E Viverette, MS, RN, CCRC    713-500-6936    Elena.E.Viverette@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Daniel H Kim, MD The University of Texas Health Science Center, Houston

Responsible Party: Daniel Hwan Kim, Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03451474     History of Changes
Other Study ID Numbers: HSC-MS-17-0081
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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