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Upper Extremity Surgery in Spinal Cord Injury

This study is currently recruiting participants.
Verified September 2016 by Ida Fox, Washington University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT01899664
First Posted: July 15, 2013
Last Update Posted: May 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Ida Fox, Washington University School of Medicine
  Purpose

The goal of the investigators work is to establish how nerve transfers can be best used to improve upper extremity function in patients with cervical level spinal cord injury (SCI). The investigators' hypothesis is that nerve transfers are safe and effective and will improve function and quality of life in patients with loss of upper function due to spinal cord injury. The investigators plan on looking at upper limb function, and health-related quality of life in patients before and after surgery to better understand how patients benefit from these treatments.

A nerve transfer procedure can be used to rewire the system to make some muscles work again following SCI. The nerve transfer procedure (which is done in the arm and not at the level of the spinal cord) can be used to bypass the damaged area and to deliver a signal from the brain to a muscle that became disconnected following that injury. A donor nerve is taken from another muscle whose use is not essential and then transferred to help in providing more a more critical function.

For example, one type of nerve transfer is done to restore the lost ability to pinch or grasp small objects between the fingers that occurs in many patients with cervical SCI. In this surgery, a donor nerve that normally helps flex the elbow. This nerve can be used because the biceps muscle is also working to flex the elbow. This donor nerve is cut and re-attached to the nerve going to muscles in the forearm that provide pinch by bending the tips of the thumb and index finger.

Because the nerve transfer procedure involves cutting and reattaching nerve and muscle tissues, time is required to regenerate working connections between the nerves and muscle as well as to allow the brain to relearn how to use and strengthen that muscle.


Condition Intervention
Quadriplegia Spinal Cord Diseases Spinal Cord Injuries Procedure: Nerve Transfer Surgery

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:

Subjects will undergo the following:

A full International Standards for Neurological Classification of SCI exam will be completed to determine exact function and type of spinal cord injury.

A phone interview will be completed at both preoperative and postoperative time points.

Quality of life before and after surgical intervention will be derived from standardized questionnaires: Spinal Cord Independence Measure (SCIM), SF-36, Novak scale, and pain questionnaires.

Additional qualitative and quantitative data on donor and recipient nerve function and tissue will be derived from preoperative electrodiagnostic studies.

Specimens of the donor and recipient nerve are collected for histologic analysis during the operative procedure. Those trimmed nerve specimens are then analyzed for clinical purposes to give patients an idea of expected outcome in a more timely fashion.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the Surgical Treatment of Cervical Spinal Cord Injuries With Nerve Transfers to Restore Upper Extremity and Hand Function

Resource links provided by NLM:


Further study details as provided by Ida Fox, Washington University School of Medicine:

Primary Outcome Measures:
  • Upper extremity function. [ Time Frame: change from baseline at 6, 12, 24, 30 and 36 months post-surgery ]
    Upper extremity function as measured by manual muscle testing and range of motion as well as the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) test (this is a standardized functional test to assess upper extremity function in patients with spinal cord injury) and International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) test (this is an examination used to determine the motor and sensory impairment and severity of a spinal cord injury).


Secondary Outcome Measures:
  • Health related quality of life. [ Time Frame: change from baseline at 6, 12, 24, 30 and 36 months post-surgery ]

    The Short Form (SF) -36, Spinal Cord Independence Measure (SCIM), Canadian Occupational Performance Measure (COPM) will be used to provide information about the patients quality of life and function.

    Semi-structured interviews will be performed at 12-18 months following surgery to gain information about patient satisfaction, acceptability, and the subjective experience of the surgical intervention, therapy and functional outcome.



Estimated Enrollment: 50
Study Start Date: June 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Primary Study Population
Study participants (primary study population) will include patients with spinal cord injury at the mid cervical level who are undergoing evaluation for possible surgical treatment with nerve transfers and or tendon transfer/tenodesis to improve their upper extremity function. All enrolled participants will receive the same standard of care surgical procedures.
Procedure: Nerve Transfer Surgery
Unilateral surgery will be performed under general non-paralytic anesthesia and no-tourniquet conditions to allow for responsive nerve simulation.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis of cervical level spinal cord injury
  • some upper extremity dysfunction (ex: lack of wrist extension or hand function)
  • greater then 6 months post-injury or with stable neurologic function for at least 6 months post-injury
  • good access to and ability to pay for hand and physical therapy
  • ability to comply and participate in rigorous post-surgical therapy regimen

Exclusion Criteria:

  • severe autonomic dysreflexia
  • open pressure sores or other wounds
  • respiratory insufficiency
  • untreated urinary tract infections
  • lack of access to physical therapy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01899664


Contacts
Contact: Melanie Bassham 314-454-6089 basshamm@wudosis.wustl.edu
Contact: Jessica Carter 314-454-6089 carterj@wudosis.wustl.edu

Locations
United States, Missouri
Washington University Division of Plastic Surgery Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Melanie Bassham    314-454-6089    basshamm@wudosis.wustl.edu   
Principal Investigator: Ida K. Fox, MD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Ida K. Fox, MD Washington University School of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Ida Fox, Assistant Professor of Plastic Surgery, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01899664     History of Changes
Other Study ID Numbers: 201205104
First Submitted: July 3, 2013
First Posted: July 15, 2013
Last Update Posted: May 16, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ida Fox, Washington University School of Medicine:
peripheral nerves
quadriplegia
nerve transfer
surgical procedures, operative
hand
upper extremity
quality of life

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Quadriplegia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Paralysis
Neurologic Manifestations
Signs and Symptoms