Utility of CC7 Transfer in Stroke Subtypes

Stroke, Ischemic Clinical Trial

Official title:

Seventh Cervical Nerve Transfer for Spastic Arm Paresis: A Prospective Analysis of Efficacy in Ischemic vs. Hemorrhagic Stroke

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06001736
• Other study ID #: STUDY02000583
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 13, 2022
• Est. completion date: March 1, 2027

Study information

• Verified date: August 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 95
• Est. completion date: March 1, 2027
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhagic Stroke
• Ischemic Stroke
• Muscle Spasticity
• Paresis
• Spastic Hemiparesis
• Stroke
• Stroke Hemorrhagic
• Stroke, Ischemic

Intervention

Procedure:
• Contralateral C7 root transfer for the treatment of spastic hemiparesis.
Performing surgery to transfer the C7 nerve to treat stroke patients experiencing spastic hemiparesis.

Locations

Country	Name	City	State
United States	Dartmouth-Health	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in arm function, as measured by the Fugl-Meyer upper-extremity scale.	The Fugl-Meyer is a widely used and highly recommended stroke-speci?c, performance-based measure of impairment with 5 domains and a possible 226 points.	12 months with visits at baseline and months 2, 4, 8, and 12 months after surgery.