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Recruiting NCT06288763

Nerve Transfer to Improve Function in High Level Tetraplegia

— Observational Cervical Spinal Cord Injury Tetraplegia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cervical Spinal Cord Injury, Tetraplegia. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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)

Primary outcome measures

  • Elbow Dynamometry [Time frame: 36-48 months post-surgery]
  • Spinal Cord Independence Measure [Time frame: 36-48 months post-surgery]
  • Motor strength in medical research council grade (MRC) [Time frame: 36-48 months post-surgery]
  • Electrodiagnosis (Nerve Conduction Study and Electromyography [Time frame: 36-48 months post-surgery]
Secondary outcome measures (5)
  • Canadian Outcomes Performance Measure (COPM) [Time frame: 36-48 Months post-surgery]
  • Capabilities of Upper Extremity Questionnaire (CUE-Q) [Time frame: 36-48 Months post-surgery]
  • Modified Ashworth Scale (MAS) [Time frame: 36-48 Months post-surgery]
  • Spinal Cord Injury Quality of LIfe Questionnaire [Time frame: 36-48 Months post-surgery]
  • International SCI Pain Basic Dataset (ISCIPBDS) [Time frame: 36-48 Months post-surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 9 centers
  • Stanford University — Stanford
  • University of Miami — Miami
  • Johns Hopkins University — Baltimore
  • University of Michigan — Ann Arbor
  • Washington University in St. Louis — St Louis
  • Wake Forest Medical Center — Winston-Salem
  • University of Pennsylvania — Philadelphia
  • Houston Methodist — Houston
  • … and 1 more center
Canada · 1 center
  • University of Alberta — Edmonton

Identifiers

NCT: NCT06288763 · CDMRP-eBRAP-SC220192

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗