NCT06001736

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Mar 2022Mar 2027

Study Start

First participant enrolled

March 13, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

5 years

First QC Date

August 14, 2023

Last Update Submit

February 25, 2026

Conditions

Stroke, IschemicStroke HemorrhagicSpastic Hemiparesis

Keywords

Ischemic strokeHemorrhagic strokeSpastic hemiparesis

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months with visits at baseline and months 2, 4, 8, and 12 months after surgery.

Study Arms (1)

Contralateral C7 root transfer for the treatment of spastic hemiparesis.

EXPERIMENTAL

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

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

Interventions

Contralateral C7 root transfer for the treatment of spastic hemiparesis.PROCEDURE

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

Contralateral C7 root transfer for the treatment of spastic hemiparesis.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Health

Lebanon, New Hampshire, 03677, United States

RECRUITING

MeSH Terms

Conditions

Ischemic StrokeHemorrhagic StrokeHemiplegia

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jennifer Hong, Dr.

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Sinks

CONTACT

(603) 653-9021Lauren.J.Sinks@hitchcock.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 14, 2023

First Posted

August 21, 2023

Study Start

March 13, 2022

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

US(1)