Utility of CC7 Transfer in Stroke Subtypes

Sponsor

Dartmouth-Hitchcock Medical Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06001736

Collaborator

(none)

Enrollment

Location

Arm

59.6

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Stroke, Ischemic Stroke Hemorrhagic Spastic Hemiparesis	Procedure: Contralateral C7 root transfer for the treatment of spastic hemiparesis.	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

95 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 13, 2022

Anticipated Primary Completion Date :

Mar 1, 2027

Anticipated Study Completion Date :

Mar 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Contralateral C7 root transfer for the treatment of spastic hemiparesis. The C7 nerve root transfer will occur to the patients on this arm.	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.

Arm

Intervention/Treatment

Experimental: Contralateral C7 root transfer for the treatment of spastic hemiparesis.

The C7 nerve root transfer will occur to the patients on this arm.

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dartmouth-Health	Lebanon	New Hampshire	United States	03677

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

Investigators

Principal Investigator: Jennifer Hong, Dr., Dartmouth-Hitchcock Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jennifer Hong, Principal Investigator, Dartmouth-Hitchcock Medical Center

ClinicalTrials.gov Identifier:

NCT06001736

Other Study ID Numbers:

STUDY02000583

First Posted:

Aug 21, 2023

Last Update Posted:

Aug 23, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 23, 2023