Nerve Transfer After Spinal Cord Injuries | NCT01714349

Studies
Nerve Transfer After Spinal Cord Injuries

NCT01714349

Sponsor

Washington University School of Medicine

Status

Completed

Last Update Posted

Jul 6, 2026Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Spinal Cord Injury

Interventions

Nerve Transfer

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CDMRP-SC140051	Other Identifier	eBRAP log number

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Mar 20, 2023Actual

Completion Date

Mar 20, 2023Actual

First Submitted Date

Oct 22, 2012

First Submission Date that Met QC Criteria

Oct 22, 2012

First Posted Date

Oct 25, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2026

Last Update Posted Date

Jul 6, 2026Actual

Name	Class
United States Department of Defense	FED
CDMRP	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nerve Transfer	Experimental	Surgical - Nerve transfers for patients with stable cervical spinal cord injuries	Procedure: Nerve Transfer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nerve Transfer	Procedure	A nerve transfer procedure will be individualized to each patient's functional deficit.	Nerve Transfer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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
Change in Short Form 36 (SF-36) scores

Other Outcomes

Measure	Description	Time Frame
Rates of Intraoperative and Post-operative complications	The number of complications within and after the operation.	48 months
Effect of timing on surgical intervention	Assess the effect of timing on primary and secondary outcome measures, early (<12 months) vs. (>12 months)

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D013119	Spinal Cord Injuries
D011782	Quadriplegia

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

ID	Term
D019635	Neurosurgical Procedures
D013514	Surgical Procedures, Operative