Nerve Transfers to Restore Hand Function in Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

Nerve Transfers to Restore Hand Function in Spinal Cord Injury

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02861612
• Other study ID #: 5313
• Status: Withdrawn
• Start date: August 2016
• Est. completion date: March 18, 2019

Study information

• Verified date: March 2019
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study seeks to evaluate the efficacy of nerve transfers in restoring hand function in patients with cervical spinal injuries.

Description:

Cervical spinal cord injury is a life‐altering injury that results in profound loss of upper limb function. Hand function is essential to basic activities of daily living and consequently has a significant impact on patients' quality of life. Tendon transfers and/or tenodesis have traditionally been used to restore hand function in spinal cord injuries - however, in recent years there is growing interest in the role of nerve transfers as a means of accomplishing this goal. Although preliminary results indicate nerve transfers may be well‐suited for patients with spinal cord injury, their long term efficacy has not been demonstrated.

This study seeks to evaluate the efficacy of nerve transfers in restoring hand function in patients with cervical spinal injuries. Eligible patients will receive nerve transfer procedure(s) (e.g. brachialis to anterior interosseous nerve, supinator to posterior interosseous) and will be followed post-operatively to assess for changes in strength, functional independence, and quality of life.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 18, 2019
• Est. primary completion date: March 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients with a spinal cord injury AIS level C5 to C7. Those with motor complete injuries (AIS A or B) will be considered for surgical intervention if they are = 5 months post injury. Motor incomplete patients (AIS C or D) will be considered if they are = 1.5 years post injury.

• Patients will require = MRC 4 strength of the muscle supplied by the donor nerve (e.g. brachialis, supinator).

• Finger flexor and extensor strength should be = MRC 1 strength.

• Muscles supplied by the donor nerve, will need to have no or minimal of evidence of lower motor neuron injury as dictated by evidence of fibrillations, positive sharp waves, or moderate or severely decreased recruitment on needle electromyography.

• Those being evaluated for surgery outside nine-months post injury recipient muscles will be required to be free of lower motor neuron pathology.

• Ability to comply and participate in rigorous post-surgical therapy regimen.

Exclusion Criteria:

• Comorbidities precluding safe surgery including autonomic/hemodynamic instability, pulmonary instability, active infection, chronic pressure sores or untreated urinary tract infections as determined by physician.

• Simultaneous tendon transfer or tenodesis surgery (which would preclude separation of the effect of nerve transfer alone).

Related Conditions & MeSH terms

• Quadriplegia
• Spinal Cord Diseases
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Procedure:
• Nerve Transfer Surgery
Unilateral surgery will be performed under general non-paralytic anesthesia and no-tourniquet conditions to allow for responsive nerve simulation.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (5)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Canadian Society of Plastic Surgeons, Ontario Neurotrauma Foundation, Rick Hansen Institute, Washington University School of Medicine

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

Fox IK, Davidge KM, Novak CB, Hoben G, Kahn LC, Juknis N, Ruvinskaya R, Mackinnon SE. Nerve Transfers to Restore Upper Extremity Function in Cervical Spinal Cord Injury: Update and Preliminary Outcomes. Plast Reconstr Surg. 2015 Oct;136(4):780-92. doi: 10.1097/PRS.0000000000001641. Review. — View Citation

Fox IK, Davidge KM, Novak CB, Hoben G, Kahn LC, Juknis N, Ruvinskaya R, Mackinnon SE. Use of peripheral nerve transfers in tetraplegia: evaluation of feasibility and morbidity. Hand (N Y). 2015 Mar;10(1):60-7. doi: 10.1007/s11552-014-9677-z. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Upper extremity function - Myometric measures of strength (donor and recipient muscle groups)	Valid and reliable quantitative muscle strength measurement	Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
Primary	Upper extremity function - Manual muscle testing (MRC)	Quantitative assessment of motor function (MRC)	Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
Primary	Upper extremity function - Graded Redefined Assessment of Strength, Sensibility and Prehension test (GRASSP)	Valid, reliable and responsive measure of sensorimotor upper limb impairment specifically designed for patients with cervical SCI	Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
Primary	Upper extremity function - Range of motion	Quantitative assessment of range of motion (degrees)	Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
Secondary	Health related quality of life - The Short Form (SF)-36	Valid and responsive measure of quality of life in surgical patients	Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
Secondary	Health related quality of life - Spinal Cord Independence Measure (SCIM I)	Disability scale developed to specifically address the ability of SCI patients to perform basic activities of daily living independently	Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
Secondary	Health related quality of life - Canadian Occupational Performance Measure (COPM)	Evidence-based outcome measure designed to capture a patient's self-perception of performance in everyday living	Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
Secondary	Health related quality of life - Semi-structured interviews	Semi-structured interviews to gain information about satisfaction, acceptability, and the subjective experience of the surgical intervention, therapy, and functional outcome	Collected at 12 and 24 months post-surgery.