Nerve Transfer After Spinal Cord Injuries

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01714349
• Other study ID #: NTSCI -201208137
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: March 20, 2023

Study information

• Verified date: March 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 20, 2023
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 18-65 years of age

2. Informed Consent Document (ICD) signed by patient

3. Cervical spinal cord injury resulting in arm & hand functional impairment, with at least preserved elbow function

4. International Classification of Surgery of the Hand in Tetraplegia (ICSHT) category 0

• 4

5. 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

6. Appropriate candidate for nerve transfer study

7. Willing and able to comply with the study protocol

8. < 48 months from injury

Exclusion Criteria:

1. Active infection at the operative site or systemic infection

2. Any return or ongoing clinical recovery of distal motor function within 6 months after injury

3. Physically or mentally compromised

4. Currently undergoing long-term steroid therapy

5. Significant joint contractures and/or limitations in passive range of motion in the arm or hand

6. Active malignancy

7. Systemic disease that would affect the patient's welfare or the research study

8. Pregnant

9. Immunologically suppressed or immunocompromised

10. Significant pain or hypersensitivity

11. Previous or current injury preventing use of tendon transfers to restore upper extremity function

12. Affective disorder of a degree that would make outcome assessment and study participation difficult

13. History of brachial plexus injury or systemic neuropathic process

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Procedure:
• Nerve Transfer
A nerve transfer procedure will be individualized to each patient's functional deficit.

Locations

Country	Name	City	State
United States	Washington University	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rates of Intraoperative and Post-operative complications	The number of complications within and after the operation.	48 months
Other	Effect of timing on surgical intervention	Assess the effect of timing on primary and secondary outcome measures, early (<12 months) vs. (>12 months)	48 months
Other	Rate of reoperation	The rate at which a patient needs to be operated on again.	48 months
Other	Hand Function, measured by the Sollerman Hand Function Test	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	48 months
Primary	Change in upper motor strength	Patients motor strength will be assessed over 48 months of clinical follow-up with conventional manual motor testing	48 months
Secondary	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.	48 months
Secondary	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.	48 months
Secondary	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.	48 months

External Links

•   Washington University Neurosurgery Home Page