- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03243318
Motor Evoked Potential in the Affected Upper Limb Predicts the Potential of Motor Recovery in Subacute Stroke Patients
May 21, 2022 updated by: Eric Man Pun Yeung, Hospital Authority, Hong Kong
Stroke is the third common cause of adult disability in dveloped countries.
Early identification of the potential for motor recovery is important to avoid 'learned disuse' and to initiate appropriate therapy with achievable goals.
The current cohort study focuses on those patients with SAFE <8 and using motor evoked potentials (MEPs) to improve on prognostication of upper limb motor recovery among subacute stroke patients in a local stroke population.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
32
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hong Kong, Hong Kong
- Department of Rehabilitation, Kowloon Hospital
-
-
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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Subacute stroke patients
Description
Inclusion Criteria:
- First stroke with hemiparesis or hemiplegia with SAFE <8
Exclusion Criteria:
- contra-indication to TMS or MRI, history of seizure, pregnancy and mentally unfit to understand the consent
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Presence of motor evoked potentials
Those patients with Shoulder Abduction and Finger Extension (SAFE) score <8/10 with the presence of motor evoked potentials elicited by TMS over the ipsilesional motor cortex
|
Using TMS induced MEPs over motor cortex of the affected side to predict motor recovery potentials
|
|
absence of motor evoked potentials
Those patients with Shoulder Abduction and Finger Extension (SAFE) score <8/10 with the absence of motor evoked potentials elicited by TMS over the ipsilesional motor cortex
|
Using TMS induced MEPs over motor cortex of the affected side to predict motor recovery potentials
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Action Research Arm Test
Time Frame: Change of Baseline Action Research Arm Test at 12 weeks post-stroke
|
Upper limb functional test
|
Change of Baseline Action Research Arm Test at 12 weeks post-stroke
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
October 11, 2017
Primary Completion (Actual)
October 31, 2021
Study Completion (Actual)
November 30, 2021
Study Registration Dates
First Submitted
August 4, 2017
First Submitted That Met QC Criteria
August 7, 2017
First Posted (Actual)
August 9, 2017
Study Record Updates
Last Update Posted (Actual)
May 26, 2022
Last Update Submitted That Met QC Criteria
May 21, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KHMEPsUL2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
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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