Upper Extremity Surgery in Spinal Cord Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Ida Fox, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01899664
First received: July 3, 2013
Last updated: July 10, 2013
Last verified: July 2013
  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: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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 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 ] [ Designated as safety issue: No ]
    Upper extremity function as measured by manual muscle testing and range of motion as well as the GRASSP (Graded Redefined Assessment of Strength, Sensibility and Prehension) test (this is a standardized functional test to assess upper extremity function in patients with 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 ] [ Designated as safety issue: No ]

    The SF-8 (short form 8) and SCIM (Spinal Cord Independence Measure) standardized questionnaires 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.



Biospecimen Retention:   Samples Without DNA

Nerve tissue specimens will be obtained at the time of surgery for histologic examination and assessment of nerve tissue quality.


Estimated Enrollment: 50
Study Start Date: June 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Nerve Transfer Surgery
This is an observational study that looks at function and quality of life in patients before and after nerve transfer surgery.
Procedure: Nerve Transfer Surgery

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Any patients with cervical spinal cord injury and upper extremity dysfunction who are medically stable, residents of the United States, willing and able to be assessed at the Washington University Multidisciplinary Upper Extremity Surgery in Spinal Cord Injury clinic are potential participants.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01899664

Contacts
Contact: Debbie Graham 314-454-6089 grahamd@wudosis.wustl.edu
Contact: Tammie Newhouse, MA 314-362-7388 newhouset@wudosis.wustl.edu

Locations
United States, Missouri
Washington University Division of Plastic Surgery Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Debbie Graham    314-454-6089    grahamd@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 Early Recognition Center
  More Information

No publications provided

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
Study First Received: July 3, 2013
Last Updated: July 10, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Quadriplegia
Retinitis Pigmentosa
Spinal Cord Diseases
Spinal Cord Injuries
Central Nervous System Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Nervous System Diseases
Neurologic Manifestations
Paralysis
Retinal Degeneration
Retinal Diseases
Retinal Dystrophies
Signs and Symptoms
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014