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Study Details

NERVE TRANSFERS TO IMPROVE UPPER EXTREMITY FUNCTION AND QUALITY OF LIFE IN TETRAPLEGIC PATIENTS

(IRB#: IRB_00126462)

The purpose of this study is to gather information about the treatment of Spinal Cord Injury (SCI) through the use of a surgical procedure known as a nerve transfer. SCI is a devastating condition which is thought to affect nearly 40 cases per million persons annually in the US. More than 50% SCI occur in the cervical spine (i.e., tetraplegia), resulting in some loss of arm and/or hand function. Nerve transfers are used to improve upper extremity and hand function in patients who have suffered from SCI. This is a treatment option that is available to all (appropriate) patients, and participation in this study is not necessary to receive this treatment. Participation in this study is voluntary, and is available only to those who meet certain eligibility criteria. These criteria will be reviewed on a case by case basis by the University of Utah Department of Neurosurgery's study team as potential participants express their interest in the study. Various appointments and/or diagnostic procedures may be scheduled in order to ensure the eligibility of potential patients. There is no financial cost to patients (aside from the standard costs of care) who participate in this study, and there are no direct financial benefits provided for doing so. Participants will be followed after the procedure both by the surgeon and the physical therapy team. This study does provide funding for the physical therapy services utilized in the long-term follow up phase, but this funding is limited. So participants are encouraged to schedule these visits appropriately. The information provided on this page is not exhaustive, so those who are interested in this study are encouraged to contact our study team to discuss any questions they might have. You can do this by contacting the study coordinator, Kirby Taylor, via telephone or email.

I AM INTERESTED

  • All genders
  • Over 18 years old
  • Healthy Volunteers
  •   In Person
  • Paid

Who can participate?

 Gender: All genders

  Age: Over 18 years old

  Volunteers: Healthy Volunteers

   Location: In Person

Inclusion Criteria

  • Must be between the ages of 18 and 65.
  • Must complete at least 3 months of non-operative rehab therapy.
  • The spinal cord injury must have occurred within the past 36 months. Must also have diagnosis of tetraplegia.
  • The spinal cord injury must have occurred at or between the levels of C4 and C8.
  • Other inclusion criteria to be reviewed by study team.

Exclusion Criteria

  • Must not have an active infection at the operative site, or systemic infection.
  • Must not have any return or clinical recovery of distal motor function (past or ongoing).
  • Must not have received a tendon transfer, or be scheduled for one throughout the duration of the study.
  • Must not be pregnant, immunologically compromised, have an active malignancy, or be undergoing long-term steroid treatment.
  • Other exclusion criteria to be reviewed by study team.

Will I be paid for my time?

Yes

For more information contact:

Kirstianna Lombardi

u6039943@utah.edu

  801.585.9821

IRB#: IRB_00126462

PI: Mark Mahan

Department: NEUROSURGERY

Approval Date: 2020-01-16 07:00:00

Study Categories: Brain Health Studies

Specialties: Neurosurgery, Physical Therapy

Last Updated: 6/8/23