StrokeNCT03365596
Recovery Prediction of Motor Function Using Neuroimaging Techniques in Subacute Stroke Patients
An observational study of Stroke, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Prediction of recovery from stroke can assist in the planning of impairment-focused rehabilitation. To achieve better prediction for clinical purposes, this study investigated a new prediction model with low inter-individual variability and high accuracy using neuroimaging techniques. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Conventional therapy
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2017to 26 Jan 2023
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: First-ever stroke patients at subacute stage.
Who may be able to join
- First-ever stroke patients
- Unilateral stroke
- Subacute stage (less than 4 weeks)
Who cannot join
- Major active neurological disease or psychiatric disease
- A history of seizure
- Metallic implants in their brain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional MRI and DTI Study for Brain Network Analysis and Recovery Prediction in Subacute Stroke Patients
Prediction of recovery from stroke can assist in the planning of impairment-focused rehabilitation. To achieve better prediction for clinical purposes, this study investigated a new prediction model with low inter-individual variability and high accuracy using neuroimaging techniques.
- Conditions
- Stroke
- Being tested
- Conventional therapy
- Keywords
- Brain connectivity, Magnetic resonance imaging, Recovery prediction
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional therapyOther
According to the status of a patient, optimized therapy will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Subacute stroke | Not described Receives: Other: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment score at 3 months after stroke onset
Measurement of motor function of upper and lower extremities
Measured: 3 months after stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start1 Jun 2017
- Primary completion30 Dec 2022
- Study completion26 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365596
- Sponsor's protocol ID
- 2017-02-107
- Status last verified
- Jul 2019
- First submitted
- 27 Nov 2017
- Last updated
- 8 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional MRI and DTI Study for Brain Network Analysis and Recovery Prediction in Subacute Stroke Patients
- ClinicalTrials.gov ID
- NCT03365596
- Acronym / sponsor ID
- 2017-02-107
- Conditions
- Stroke
- Keywords
- Brain connectivity, Magnetic resonance imaging, Recovery prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 26 Jan 2023 (actual)
- First posted
- 7 Dec 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.
Prediction of recovery from stroke can assist in the planning of impairment-focused rehabilitation. To achieve better prediction for clinical purposes, this study investigated a new prediction model with low inter-individual variability and high accuracy using neuroimaging techniques.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subacute stroke | – | Other: Conventional therapy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- First-ever stroke patients at subacute stage.
Key inclusion criteria (3 listed)
- First-ever stroke patients
- Unilateral stroke
- Subacute stage (less than 4 weeks)
Key exclusion criteria (3 listed)
- Major active neurological disease or psychiatric disease
- A history of seizure
- Metallic implants in their brain
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 |
|---|---|---|
| Conventional therapyAccording to the status of a patient, optimized therapy will be applied. | Other | Subacute stroke |
Primary outcome
Fugl-Meyer Assessment score at 3 months after stroke onset
Time frame: 3 months after stroke onset
Measurement of motor function of upper and lower extremities
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 8 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Stroke
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruiting
The Effects of an Augmented Reality-Based Mirror Therapy System in Patients With Stroke
Stroke
Recruiting
A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
Acute Ischemic Stroke, Acute Haemorrhagic 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, run by Samsung Medical Center at 1 site in South Korea.
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 3 inclusion and 3 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 8 Mar 2023. 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 South Korea. 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?
Fugl-Meyer Assessment score at 3 months after stroke onset (time frame: 3 months after stroke onset). 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 8 Mar 2023.