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Utility of CC7 Transfer in Stroke Subtypes

Primary Purpose

Stroke, Ischemic, Stroke Hemorrhagic, Spastic Hemiparesis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contralateral C7 root transfer for the treatment of spastic hemiparesis.
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Dartmouth-Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Contralateral C7 root transfer for the treatment of spastic hemiparesis.

Arm Description

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

Outcomes

Primary Outcome Measures

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-specific, performance-based measure of impairment with 5 domains and a possible 226 points.

Secondary Outcome Measures

Full Information

First Posted
August 14, 2023
Last Updated
August 21, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT06001736
Brief Title
Utility of CC7 Transfer in Stroke Subtypes
Official Title
Seventh Cervical Nerve Transfer for Spastic Arm Paresis: A Prospective Analysis of Efficacy in Ischemic vs. Hemorrhagic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 13, 2022 (Actual)
Primary Completion Date
March 1, 2027 (Anticipated)
Study Completion Date
March 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic, Stroke Hemorrhagic, Spastic Hemiparesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
95 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Contralateral C7 root transfer for the treatment of spastic hemiparesis.
Arm Type
Experimental
Arm Description
The C7 nerve root transfer will occur to the patients on this arm.
Intervention Type
Procedure
Intervention Name(s)
Contralateral C7 root transfer for the treatment of spastic hemiparesis.
Intervention Description
Performing surgery to transfer the C7 nerve to treat stroke patients experiencing spastic hemiparesis.
Primary Outcome Measure Information:
Title
Change from baseline in arm function, as measured by the Fugl-Meyer upper-extremity scale.
Description
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.
Time Frame
12 months with visits at baseline and months 2, 4, 8, and 12 months after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Hong, Dr.
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Health
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03677
Country
United States

12. IPD Sharing Statement

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Utility of CC7 Transfer in Stroke Subtypes

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