NCT05376098

Brief Summary

The investigators evaluate the activation and connectivity of patients' motor regions in the acute phase of ischemic stroke by fNIRS.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

February 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 17, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

May 17, 2022

Status Verified

December 1, 2021

Enrollment Period

2.4 years

First QC Date

April 1, 2022

Last Update Submit

May 15, 2022

Conditions

Keywords

StrokeMotor rehabilitationBrain regionsfNIRS

Outcome Measures

Primary Outcomes (4)

  • fNIRS characteristics of upper limb movement

    The changes in brain oxygen levels are collected in two wavelengths, including 845 and 763 nanometers using a 44 channeled fNIRS machine. The data is used to determine the position of the activated area of the brain and functional connectivity during the movement. The locations of fNIRS channels on the skull of individuals are determined due to the observations on the cortical regions of interest (ROIs), namely the contralateral sensorimotor cortex (SMC), the contralateral premotor cortex (PMC) and primary motor cortex (M1), etc.

    0-14 day

  • Assessment of upper limb function

    Recording the quality and frequency of fNIRS motion tasks including grip and reach-out movements.

    0-14 day

  • Assessment of upper limb function

    Evaluating the motor function by Action Research Arm Test.

    0-14 day

  • Assessment of upper limb function

    Evaluating the motor function by Fugl-meyer assessment.

    0-14 day

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute ischemic stroke with upper limb motor dysfunction diagnosed and treated by the Xuanwu Hospital Capital Medical University.

You may qualify if:

  • The diagnosis of ischemic stroke should meet the diagnostic criteria of the "China Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018".
  • years old≤ age ≤ 75 years old.
  • Cerebral ischemic stroke onset within 7 days.
  • First onset.
  • Upper limb motor dysfunction.

You may not qualify if:

  • Unstable vital signs.
  • Complicated with other diseases in the nervous system.
  • Combined with other serious disease states: circulatory system, respiratory system,
  • motor system diseases, such as atrial fibrillation, heart failure, lung infection, severe liver and kidney dysfunction, lower limb venous thrombosis, etc.
  • Upper limb dysfunction caused by other reasons, such as fractures, upper limb deformities, etc.
  • Contraindicated to imaging tests, such as metal implantation, claustrophobia, and severe obesity.
  • Those who cannot complete the examination due to other reasons, such as mental disorders, cognitive dysfunction, etc.
  • Other causes: alcoholism; pregnancy; skull defects; soft tissue injuries at the site of examination; visual impairment, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Ischemic StrokeStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Junwei Hao

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2022

First Posted

May 17, 2022

Study Start

February 1, 2022

Primary Completion

July 1, 2024

Study Completion

July 31, 2024

Last Updated

May 17, 2022

Record last verified: 2021-12

Locations