Back to results

Nerve Transfer After Spinal Cord Injuries

Primary Purpose

Spinal Cord Injury

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Nerve Transfer

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Spinal cord injury, nerve transfer, tetraplegia, quadriplegia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Washington University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nerve Transfer

Arm Description

Surgical - Nerve transfers for patients with stable cervical spinal cord injuries

Outcomes

Primary Outcome Measures

Change in upper motor strength

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

Secondary Outcome Measures

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

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

Change in Short Form 36 (SF-36) scores

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.

Change in Michigan Hand Questionnaire (MHQ)

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

Full Information

NCT ID

NCT01714349

First Posted

October 22, 2012

Last Updated

March 21, 2023

Sponsor

Washington University School of Medicine

Collaborators

United States Department of Defense

1. Study Identification

Unique Protocol Identification Number

NCT01714349

Brief Title

Nerve Transfer After Spinal Cord Injuries

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

March 20, 2023 (Actual)

Study Completion Date

March 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

Collaborators

United States Department of Defense

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injury

Keywords

Spinal cord injury, nerve transfer, tetraplegia, quadriplegia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nerve Transfer

Arm Type

Experimental

Arm Description

Surgical - Nerve transfers for patients with stable cervical spinal cord injuries

Intervention Type

Procedure

Intervention Name(s)

Nerve Transfer

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in upper motor strength

Description

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

Time Frame

48 months

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

48 months

Title

Change in Short Form 36 (SF-36) scores

Description

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.

Time Frame

48 months

Title

Change in Michigan Hand Questionnaire (MHQ)

Description

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

Time Frame

48 months

Other Pre-specified Outcome Measures:

Title

Rates of Intraoperative and Post-operative complications

Description

The number of complications within and after the operation.

Time Frame

48 months

Title

Effect of timing on surgical intervention

Description

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

Time Frame

48 months

Title

Rate of reoperation

Description

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

Time Frame

48 months

Title

Hand Function, measured by the Sollerman Hand Function Test

Description

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

Time Frame

48 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wilson Z Ray, MD

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Washington University

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.neurosurgery.wustl.edu

Description

Washington University Neurosurgery Home Page

Learn more about this trial

Nerve Transfer After Spinal Cord Injuries

We'll reach out to this number within 24 hrs