Nerve Transfer After Spinal Cord Injury- Multi-center

Spinal Cord Injuries Clinical Trial

Official title:

Nerve Transfers to Improve Upper Extremity Function and Quality of Life in Tetraplegic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04023591
• Other study ID #: SC180063
• Status: Recruiting
• Start date: April 13, 2020
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Washington University School of Medicine
• Contact: Linda A Koester, BS
• Phone: 314-362-7368
• Email: koesterl[@]wustl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 quality of life and functional independence.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

9. Injury Level C4-C8

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 or who have had a tendon transfer in the past.

Related Conditions & MeSH terms

• Quadriplegia
• Quadriplegia Flaccid
• Spinal Cord Injuries
• Tetraplegia

Intervention

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

Locations

Country	Name	City	State
Canada	Alberta Health Services - Foothills Medical Center	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins University	Baltimore	Maryland
United States	Houston Methodist	Houston	Texas
United States	The University of Texas Houston Health Science Center	Houston	Texas
United States	University of Miami	Miami	Florida
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Washington University	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah
United States	Stanford University	Stanford	California

Sponsors (11)

Lead Sponsor	Collaborator
Washington University School of Medicine	Johns Hopkins University, Stanford University, The Methodist Hospital Research Institute, United States Department of Defense, University of Alberta, University of Calgary, University of Miami, University of Michigan, University of Pennsylvania, University of Utah

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Manual Motor Testing	Change from baseline testing strength of upper extremities at 48 months post-operatively	48 months
Primary	Handheld Dynamometry	Change from baseline grip strength at 48 months post-operatively	48 months
Secondary	Change in Disabilities of Arm, Shoulder and Hand (DASH) scores	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.	48 months
Secondary	Change in Spinal Cord Injury Quality of Life (SCIQOL) scores	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.	48 months
Secondary	Rates of Intra-operative and post-operative complications	The number of complications within and after the operation	48 months
Secondary	Hand Function, measured by the GRASSP test	Change in baseline GRASSP Test results for hand function at 48 months post-operatively	48 months
Secondary	Changes in the Graded Redefined Assessment of Strength, Sensation and Prehension scores (GRASSP)	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.	48 months
Secondary	Neuro Quality of Life - Depression Short Form (NQOL-Dep)	Changes in baseline NQOL-Dep scores at 48 months post-operatively. Scores range from 8-40 with 8 being best outcome and 40 being the worst outcome	48 months
Secondary	Neuro Quality of Life - Upper Extremity Short Form (NQOL-UEF)	Changes in baseline NQOL-UEF scores at 48 months post-operatively. Scores range from 8-40 with 40 being the best outcome and 8 being the worst possible outcome.	48 Months

External Links

•   Washington University Neurosurgery Website