Skip to main content
OpenTrials
Completed

NCT Number: NCT01714349

Nerve Transfer After Spinal Cord Injuries

Nerve Transfer surgery can provide improved hand function following cervical spinal cord injuries

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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 Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University

St Louis, Missouri, 63110, United States

About this study

Current treatment strategies of acute cervical spinal cord injuries remain limited. Treatment options that provide meaningful improvements in patient quality of life and long-term functional independence will provide a significant public health impact.

Specific Aim: Measure the efficacy of nerve transfer surgery in the treatment of patients with complete cervical spinal cord injuries with no hand function. Optimize the efficiency of nerve transfer surgery by evaluating patient outcomes in relation to patient selection and optimal timing the the surgery.

Hypothesis: Peripheral nerve transfers in patients with spinal cord injuries will improve hand function and provide improvement in patient quality of life and functional independence.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-65 years of age
  • Informed Consent Document (ICD) signed by patient
  • Cervical spinal cord injury resulting in arm & hand functional impairment, with at least preserved elbow function
  • International Classification of Surgery of the Hand in Tetraplegia (ICSHT) category 0 - 4
  • Patients with a stable American Spinal Injury Association (ASIA) grade of A, B, or C, or with a diagnosis of central cord syndrome, showing minimal to no evidence of functional improvement in motor examination after at least 6 months of non-operative therapy post-injury
  • Appropriate candidate for nerve transfer study
  • Willing and able to comply with the study protocol
  • < 48 months from injury

Exclusion criteria

  • Active infection at the operative site or systemic infection
  • Any return or ongoing clinical recovery of distal motor function within 6 months after injury
  • Physically or mentally compromised
  • Currently undergoing long-term steroid therapy
  • Significant joint contractures and/or limitations in passive range of motion in the arm or hand
  • Active malignancy
  • Systemic disease that would affect the patient's welfare or the research study
  • Pregnant
  • Immunologically suppressed or immunocompromised
  • Significant pain or hypersensitivity
  • Previous or current injury preventing use of tendon transfers to restore upper extremity function
  • Affective disorder of a degree that would make outcome assessment and study participation difficult
  • History of brachial plexus injury or systemic neuropathic process

Treatment and study plan

nerve transfer

Procedure

A nerve transfer procedure will be individualized to each patient's functional deficit.

Primary outcomes

  1. Change in upper motor strength

    Time frame: 48 months

    Patients motor strength will be assessed over 48 months of clinical follow-up with conventional manual motor testing

Secondary outcomes

  1. Change in Disabilities of Arm, Shoulder, and Hand (DASH) scores

    Time frame: 48 months

    The change in DASH scores will be followed over time and assessed pre-operatively, 6,12, 18, 24, 36 and 48 months post-operatively.

  2. Change in Short Form 36 (SF-36) scores

    Time frame: 48 months

    The change in SF-36 scores will be followed over time and assessed pre-operatively, 6, 12, 18, 24. 36 and 48 months post-operatively.

  3. Change in Michigan Hand Questionnaire (MHQ)

    Time frame: 48 months

    The change in MHQ will be followed over time and assessed pre-operatively, 6, 12, 18, 24, 36 and 48 months post-operatively.

Other outcomes

  1. Rates of Intraoperative and Post-operative complications

    Time frame: 48 months

    The number of complications within and after the operation.

  2. Effect of timing on surgical intervention

    Time frame: 48 months

    Assess the effect of timing on primary and secondary outcome measures, early (<12 months) vs. (>12 months)

  3. Rate of reoperation

    Time frame: 48 months

    The rate at which a patient needs to be operated on again.

  4. Hand Function, measured by the Sollerman Hand Function Test

    Time frame: 48 months

    The Sollerman Hand Function Test is performed as part of an overall evaluation and assessment by study team Occupational Therapist pre-operatively, post-operatively, and at 6 months, 12 months, 18 months, and 24 months. 36 months and 48 months

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Congressionally Directed Medical Research Programs
  • United States Department of Defense

Registry information

Official study title

Restoring Hand Function Using Nerve Transfers in Persons With Spinal Cord Injury

Important dates

Study start
2012
Primary completion
2023
Study completion
2023
First posted
Oct 25, 2012
Registry last updated
Jul 6, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.