Utility of CC7 Transfer in Stroke Subtypes
Seventh Cervical Nerve Transfer for Spastic Arm Paresis: A Prospective Analysis of Efficacy in Ischemic vs. Hemorrhagic Stroke
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
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
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Jennifer Hong, Dr., Dartmouth-Hitchcock Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- STUDY02000586
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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