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NCT Number: NCT06288763

Nerve Transfer to Improve Function in High Level Tetraplegia

The goal of this observational study is to determine if nerve transfer surgeries improve upper extremity function and quality of life in patients with a high level cervical spinal cord injury.

Participants will:

* undergo standard of care pre- and post-op testing and study exams * complete pre- and post-questionnaires * undergo standard of care nerve transfer surgeries * follow-up with surgeon at 6/12/18/24/36 and potentially at 48 months * attend therapy at local therapist for up to 2 years postop.

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Key information

Conditions

Cervical Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Quadriplegia Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Tetraplegia Trauma, Nervous System Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alberta, Edmonton, Alberta, Canada

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About this study

Restoration of function in patients with high tetraplegia has been an elusive clinical challenge. There is a critical need to find an effective reconstructive therapy/procedure which improves the upper extremity function in patients with high tetraplegia.

One pure motor nerve - spinal accessory nerve (SAN) remains a viable donor in high tetraplegia patients to successfully restore elbow flexion or extension. Elbow function can provide profound independence in mobility, ventilator management and may broaden the application of assistive therapies.

The two objectives of this study are:

  • Determine if SAN nerve transfer surgery can improve the reinnervation of bicep or tricep muscles in high tetraplegia patients.
  • Determine if SAN nerve transfer surgery can reanimate upper arm function and improve functional independence in patients with high tetraplegia.

Study Activities (including standard of care (SOC))

  • Electrodiagnosis pre-op (SOC)
  • Upper extremity maximum muscle testing (SOC)
  • Questionnaires (SOC and study-related (SR))
  • Exams by a study therapist (SR)
  • Neurological exam - ISNCSCI - (SOC)
  • Nerve Transfer Surgery to be determined by surgeon (SOC)
  • Follow-up visits with surgeon at 6/12/18/24/36 and potentially 48 months
  • post-op electrodiagnostic testing (SR)
  • post-op upper extremity maximum muscle testing (SOC)
  • post-op questionnaires
  • post-op therapy exams (SR)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-80 years of age
  • High cervical SCI (motor level C1-C4)
  • Motor complete SCI AIS grade A-B
  • Plateaued spontaneous recovery for at least 6 months of non-operative therapy
  • SCI greater than 6 months and fewer than 60 months since injury
  • At least MRC 4/5 donor strength
  • Mentally and physically willing and able to comply with evaluations

Exclusion criteria

  • Active infection at the operative site or systemic infection
  • Any return or ongoing recovery of distal motor function
  • Significant joint contractures and/or limitations in passive range of motion in the arm
  • Mentally or physically compromised making it impossible to complete study activities
  • Immunologically suppressed
  • Currently undergoing long-term steroid therapy
  • Active malignancy
  • Pregnancy

Treatment and study plan

Primary outcomes

  1. Elbow Dynamometry

    Time frame: 36-48 months post-surgery

    Change from baseline to 36-48 months post-surgery. Elbow dynamometer measures muscle strength using a handheld portable dynamometer

  2. Spinal Cord Independence Measure

    Time frame: 36-48 months post-surgery

    Change from baseline to 36-48 months post-surgery. SCIM addresses three specific areas of function in patients with SCI, 1) Self-care (feeding, grooming, bathing, and dressing), 2) respiration and sphincter management, and 3) patient's mobility abilities (transfers from bed and indoors/outdoors). SCIM guide clinicians in determining treatment goals/objectives for SCI patients helping therapists assess measurable outcomes in their functional independence. Scores range from 0-100 with a higher score representing better function.

  3. Motor strength in medical research council grade (MRC)

    Time frame: 36-48 months post-surgery

    Change in baseline to 36-48 Months post-surgery. The manual muscle testing is a reliable measure of motor strength when assessed by a trained examiner. Scores range from 0-5, with the highest number representing a better score.

  4. Electrodiagnosis (Nerve Conduction Study and Electromyography

    Time frame: 36-48 months post-surgery

    Change in baseline to 36-48 Months post-surgery. NCS/EMG evaluate neuromuscular health and inform the integrity of lower motor neurons.

Secondary outcomes

  1. Canadian Outcomes Performance Measure (COPM)

    Time frame: 36-48 Months post-surgery

    Change from baseline to 36-48 months post-surgery. COPM is a validated outcome measure for SCI patients focusing on occupational performance in all areas of life. Scores range from 5-50 for performance and satisfaction. The higher scores reflect better performance and satisfaction.

  2. Capabilities of Upper Extremity Questionnaire (CUE-Q)

    Time frame: 36-48 Months post-surgery

    Change from baseline to 36-48 months post-surgery. CUE-Q detects changes in upper extremity function. Scores range from 32-224 with higher scores reflecting better function.

  3. Modified Ashworth Scale (MAS)

    Time frame: 36-48 Months post-surgery

    Change from baseline to 36-48 months post-surgery. MAS is a reliable measure for rating spasticity in SCI. Scores range from 0-32 with higher scores reflecting better function.

  4. Spinal Cord Injury Quality of LIfe Questionnaire

    Time frame: 36-48 Months post-surgery

    Change from baseline to 36-48 months post-surgery. SCI-QOL is designed to measure subjective quality of life in terms of satisfaction and importance. Range of scores is 0 to 30 with the higher scores reflecting a better quality of life..

  5. International SCI Pain Basic Dataset (ISCIPBDS)

    Time frame: 36-48 Months post-surgery

    Change from baseline to 36-48 months post-surgery. ISCIPBDS correctly classifies pain, determines its intensity and broad impact on daily activities. Lower scores reflect less pain/less interference in daily life.

Study contacts

Contact information is provided by the study sponsor or research team.

Linda Koester, BS

CONTACT

[email protected]

314-362-7368

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Congressionally Directed Medical Research Programs
  • Johns Hopkins University
  • Stanford University
  • The Methodist Hospital Research Institute
  • University of Alberta
  • University of Miami
  • University of Michigan
  • University of Pennsylvania
  • University of Utah
  • Wake Forest University Health Sciences

Registry information

Official study title

Nerve Transfer to Restore Upper Limb Function and Quality of Life in High Tetraplegia

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 1, 2024
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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