- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06001736
Utility of CC7 Transfer in Stroke Subtypes
February 25, 2026 updated by: Jennifer Hong, Dartmouth-Hitchcock Medical Center
Seventh Cervical Nerve Transfer for Spastic Arm Paresis: A Prospective Analysis of Efficacy in Ischemic vs. Hemorrhagic Stroke
The purpose of this study is to evaluate the limb functional improvement after contralateral C7 root transfer in stroke patients.
Study Overview
Status
Recruiting
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
95
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lauren Sinks
- Phone Number: (603) 653-9021
- Email: Lauren.J.Sinks@hitchcock.org
Study Locations
-
-
New Hampshire
-
Lebanon, New Hampshire, United States, 03677
- Recruiting
- Dartmouth-Health
-
Contact:
- Lauren Sinks, MPH
- Phone Number: 603-653-9021
- Email: Lauren.J.Sinks@Hitchcock.org
-
Principal Investigator:
- Jennifer Hong, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- History of ischemic or hemorrhagic stroke with resultant arm paresis that has ceased to improve within 1-5 years of rehabilitation.
- baseline Fugl-Meyer score below 33
Exclusion Criteria:
- pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Performing surgery to transfer the C7 nerve to treat stroke patients experiencing spastic hemiparesis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in arm function, as measured by the Fugl-Meyer upper-extremity scale.
Time Frame: 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.
|
12 months with visits at baseline and months 2, 4, 8, and 12 months after surgery.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jennifer Hong, Dr., Dartmouth-Hitchcock Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 13, 2022
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Study Registration Dates
First Submitted
August 14, 2023
First Submitted That Met QC Criteria
August 14, 2023
First Posted (Actual)
August 21, 2023
Study Record Updates
Last Update Posted (Actual)
February 27, 2026
Last Update Submitted That Met QC Criteria
February 25, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY02000586
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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