Stroke, SubacuteNCT03243318
Motor Evoked Potential in the Affected Upper Limb Predicts the Potential of Motor Recovery in Subacute Stroke Patients
An observational study of Stroke, Subacute, run by Hospital Authority, Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Subacute
- What is being tested?
- MEPs induced by TMS
- How many people
- 32 participants
- Where
- 1 siteHong Kong
- Study dates
- 11 Oct 2017to 30 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subacute stroke patients
Who may be able to join
- First stroke with hemiparesis or hemiplegia with SAFE <8
Who cannot join
- contra-indication to TMS or MRI, history of seizure, pregnancy and mentally unfit to understand the consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Stroke, Subacute
- Being tested
- MEPs induced by TMS
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEPs induced by TMSDiagnostic test
Using TMS induced MEPs over motor cortex of the affected side to predict motor recovery potentials
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: MEPs induced by TMS | |
| 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 Receives: Diagnostic Test: MEPs induced by TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test
Upper limb functional test
Measured: Change of Baseline Action Research Arm Test at 12 weeks post-stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start11 Oct 2017
- Primary completion31 Oct 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, SubacuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eric Man Pun Yeung, Hospital Authority, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243318
- Sponsor's protocol ID
- KHMEPsUL2017
- Status last verified
- May 2022
- First submitted
- 4 Aug 2017
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Evoked Potential in the Affected Upper Limb Predicts the Potential of Motor Recovery in Subacute Stroke Patients
- ClinicalTrials.gov ID
- NCT03243318
- Acronym / sponsor ID
- KHMEPsUL2017
- Conditions
- Stroke, Subacute
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 9 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Presence of motor evoked potentials | – | Diagnostic Test: MEPs induced by TMSThose 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 |
| absence of motor evoked potentials | – | Diagnostic Test: MEPs induced by TMSThose 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subacute stroke patients
Key inclusion criteria (1 listed)
- First stroke with hemiparesis or hemiplegia with SAFE <8
Key exclusion criteria (1 listed)
- contra-indication to TMS or MRI, history of seizure, pregnancy and mentally unfit to understand the consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEPs induced by TMSUsing TMS induced MEPs over motor cortex of the affected side to predict motor recovery potentials | Diagnostic test | Presence of motor evoked potentials, absence of motor evoked potentials |
Primary outcome
Action Research Arm Test
Time frame: Change of Baseline Action Research Arm Test at 12 weeks post-stroke
Upper limb functional test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Individual participant dataSharing planned: No
Related trials for Stroke, Subacute
Recruiting
Functional Improvement in Subacute/Chronic Stroke Through Non-invasive Virtual-reality-Based Telerehabilitation
Stroke
Active, not recruiting
Comparative Effects of Sensorimotor Training and tACS on Upper Limb Function and Cervical Proprioception in Subacute Stroke
Sub-acute Stroke
RecruitingObservational study
Stroke Hemiplegic Shoulder Pain: Ultrasound Findings and VAS (Cross-Sectional)
Hemiplegic Shoulder Pain, Stroke
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Subacute, run by Hospital Authority, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Action Research Arm Test (time frame: Change of Baseline Action Research Arm Test at 12 weeks post-stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.