Utility of CC7 Transfer in Stroke Subtypes

Not Applicable

Recruiting

• Conditions: Stroke Hemorrhagic; Stroke, Ischemic; Spastic Hemiparesis
• Interventions: Procedure: Contralateral C7 root transfer for the treatment of spastic hemiparesis.

• Registration Number: NCT06001736
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

The purpose of this study is to evaluate the limb functional improvement after contralateral C7 root transfer in stroke patients.

Detailed Description

Spastic limb paresis after stroke is a cause of long-term disability and reduction is quality of life, with loss of hand dexterity being especially prohibitive. In the recovery phase after initial injury, neural reorganization occurs and has been observed in both ipsilateral and contralateral hemispheres. Previous studies have identified contralesional (opposite to the side of the injury), in other words, ipsilateral, activation in the recovery of paretic hand function. However, this pathway of recovery is limited due to sparse connections between the ipsilateral hemisphere and the affected arm/hand. By establishing an anatomic connection between the ipsilateral hemisphere and the paretic arm with contralateral nerve transfer, compensatory capacity of the ipsilateral hemisphere is facilitated. This cross neck C7-C7 root transfer is an established procedure for the treatment of brachial plexus injuries and recently, for the treatment of spastic arm paresis in those with cerebral injury.

Study Timeline

• Study Start: 2022-03-13
• Study First Submitted: 2023-08-14
• Study First Submitted QC: 2023-08-14
• Study First Posted: 2023-08-21
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-20
• Last Update Posted: 2024-10-22
• Primary Completion: 2027-03-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

• History of ischemic or hemorrhagic stroke with resultant arm paresis that has ceased to improve within 1-5 years of rehabilitation.

Exclusion Criteria

• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Contralateral C7 root transfer for the treatment of spastic hemiparesis.	Contralateral C7 root transfer for the treatment of spastic hemiparesis.	The C7 nerve root transfer will occur to the patients on this arm.

Primary Outcome Measures

Name	Time	Method
Change from baseline in arm function, as measured by the Fugl-Meyer upper-extremity scale.	12 months with visits at baseline and months 2, 4, 8, and 12 months after surgery.	The Fugl-Meyer is a widely used and highly recommended stroke-specific, performance-based measure of impairment with 5 domains and a possible 226 points.

Trial Locations

Locations (1)

Dartmouth-Health; 🇺🇸 Lebanon, New Hampshire, United States