Recruiting

Nerve Transfer

Sponsor:

Washington University School of Medicine

Code:

NCT06288763

Conditions

Cervical Spinal Cord Injury

Tetraplegia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Cervical Spinal Cord Injury

Tetraplegia

Study ID

NCT06288763

Start date

Feb 5, 2024

Status verified date

Mar, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Linda Koester, BS

314-362-7368koesterl@wustl.edu

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Anthony Bet

650-683-5823abet0915@stanford.edu

Principal Investigator:

Thomas J Wilson, MD

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

George Jimsheleishvili, MD

305-243-4781gxi150@med.miami.edu

Patricia Graham

305-243-5119pgraham1@med.miami.edu

Principal Investigator:

Stephen S Burks, MD

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Chava Roberts

667-306-8862crober83@jh.edu

Ala Elhelali

aelhela1@jhmi.edu

Principal Investigator:

Sami Tuffaha, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Savannah Solomon

734-936-7010ssavanna@med.umich.edu

Principal Investigator:

Yamaan Saadeh, MD

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Linda Koester

13143627368koesterl@wustl.edu

Principal Investigator:

Wilson Z. Ray, MD

Wake Forest Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Wendy Jenkins

336-716-3842wendy.jenkins@advocatehealth.org

Kim Hawley

kimberly.hawley@advocatehealth.org

Principal Investigator:

Christopher Dibble, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Leah Coghlan

215-341-5864leah.coghlan@pennmedicine.upenn.edu

Gabrielle Dupre

gabrielle.dupre@pennmedicine.upenn.edu

Principal Investigator:

Eric Zager, MD

Houston Methodist

Recruiting

Houston, Texas, United States, 77030

Contacts

Amber Behne

346-238-6424abehne@houstonmethodist.org

Sergio Ibarra Cortez

346-238-2494shibarracortez@houstonmethodist.org

Principal Investigator:

Amir Faraji, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Kirstianna Lombardi

801-585-9821kirstianna.lombardi@utah.edu

Douglas Gibula

douglas.gibula@hsc.utah.edu

Principal Investigator:

Mark Mahan, MD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Keywords

  • Spinal Cord Injury
  • Cervical spinal cord injury
  • Nerve Transfer Surgery
  • High Cervical Spinal Cord Injury
  • Cervical SCI
  • Tetraplegia
  • Quadriplegia
  • Nerve transfer
  • Spinal Accessory Nerve

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-03-11.