Utility of CC7 Transfer in Stroke Subtypes

NCT ID: NCT06001736

Last Updated: 2024-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-13

Study Completion Date

2027-03-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Stroke, Ischemic Stroke Hemorrhagic Spastic Hemiparesis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Contralateral C7 root transfer for the treatment of spastic hemiparesis.

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

Group Type EXPERIMENTAL

Contralateral C7 root transfer for the treatment of spastic hemiparesis.

Intervention Type PROCEDURE

Performing surgery to transfer the C7 nerve to treat stroke patients experiencing spastic hemiparesis.

Interventions

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Contralateral C7 root transfer for the treatment of spastic hemiparesis.

Performing surgery to transfer the C7 nerve to treat stroke patients experiencing spastic hemiparesis.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Hong

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Hong, Dr.

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

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Dartmouth-Health

Lebanon, New Hampshire, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Beverly Allen, BS

Role: CONTACT

603-653-9021

Facility Contacts

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Beverly Allen, BS

Role: primary

603-653-9021

Jennifer Hong, MD

Role: backup

Other Identifiers

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STUDY02000583

Identifier Type: -

Identifier Source: org_study_id

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