StrokeNCT05254964
Effect of Intensive Cognitive Rehabilitation on Cognitive, Motor, and Language Functional Networks in Subacute Stroke Patient
A study testing Cognitive rehabilitation in people with Stroke, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Altered brain networks, including cognitive, motor, and language networks, are investigated by intensive cognitive rehabilitation in subacute stroke patients. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Cognitive rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2022to 28 Feb 2023
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 19 to 80 years
- Patients with subacute stroke within 2 weeks of onset
- First-ever stroke
- Supratentorial stroke
- Less than 8 SAFE (shoulder abduction, finger extension) points
- Less than 35 FMA Upper scores
- MEP (motor evoked potential) negative
- Not more than 24 K-MMSE (Korean Mini-Mental State Examination) score
Who cannot join
- Difficult to communicate due to severe language impairment.
- Accompanied by an existing serious neurogenic disease
- Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder
- If there are difficulties in conducting the research
- Any patients who are judged by the investigator to be difficult to participate in this study
- Patients with contraindicated MRI scans
Trial locations and contacts
1 site in 1 country.
About this study
Altered brain networks, including cognitive, motor, and language networks, are investigated by intensive cognitive rehabilitation in subacute stroke patients.
- Conditions
- Stroke
- Being tested
- Cognitive rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive rehabilitationProcedure or surgery
Intensive cognitive rehabilitation by cognitive therapist for 1 hour on every working 20 days (4 weeks) during the subacute stroke phase
| Study group | Role | What they receive |
|---|---|---|
| Intensive cognitive rehabilitation group | Experimental | Participants receive intensive cognitive rehabilitation for 20 hours for 4 weeks. Receives: Procedure: Cognitive rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength of connectivity in brain network obtained from MRI neuroimaging data
Participants' MRI neuroimaging data are acquired at pre- and post-intervention. Brain network can be constructed using MRI neuroimaging data, and strength of connectivity can be calculated in the brain network. Strength of connectivity has a value between -1 and 1.
Measured: Change in strength of connectivity after intensive cognitive rehabilitation for 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start1 Feb 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Why it stopped: Patients not recruited.
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yun-Hee Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254964
- Sponsor's protocol ID
- 2021-12-019
- Status last verified
- Mar 2023
- First submitted
- 9 Feb 2022
- Last updated
- 7 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intensive Cognitive Rehabilitation on Cognitive, Motor, and Language Functional Networks in Subacute Stroke Patient
- ClinicalTrials.gov ID
- NCT05254964
- Acronym / sponsor ID
- 2021-12-019
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Patients not recruited.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 24 Feb 2022 (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.
Altered brain networks, including cognitive, motor, and language networks, are investigated by intensive cognitive rehabilitation in subacute stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intensive cognitive rehabilitation group | Experimental | Procedure: Cognitive rehabilitationParticipants receive intensive cognitive rehabilitation for 20 hours for 4 weeks. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients aged 19 to 80 years
- Patients with subacute stroke within 2 weeks of onset
- First-ever stroke
- Supratentorial stroke
- Less than 8 SAFE (shoulder abduction, finger extension) points
Key exclusion criteria (6 listed)
- Difficult to communicate due to severe language impairment.
- Accompanied by an existing serious neurogenic disease
- Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder
- If there are difficulties in conducting the research
- Any patients who are judged by the investigator to be difficult to participate in this study
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 |
|---|---|---|
| Cognitive rehabilitationIntensive cognitive rehabilitation by cognitive therapist for 1 hour on every working 20 days (4 weeks) during the subacute stroke phase | Procedure or surgery | Intensive cognitive rehabilitation group |
Primary outcome
Strength of connectivity in brain network obtained from MRI neuroimaging data
Time frame: Change in strength of connectivity after intensive cognitive rehabilitation for 4 weeks
Participants' MRI neuroimaging data are acquired at pre- and post-intervention. Brain network can be constructed using MRI neuroimaging data, and strength of connectivity can be calculated in the brain network. Strength of connectivity has a value between -1 and 1.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
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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?
A study testing Cognitive rehabilitation in people with 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 8 inclusion and 6 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: withdrawn, as of the sponsor's last update on 7 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 was withdrawn before enrolling participants, so there are no results.
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?
Strength of connectivity in brain network obtained from MRI neuroimaging data (time frame: Change in strength of connectivity after intensive cognitive rehabilitation for 4 weeks). 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 7 Mar 2023.