StrokeNCT04570774
Effect of Cerebral and Cerebellar rTMS in Stroke Patient
A study testing Repetitive transcranial magnetic stimulation in people with Stroke and Repetitive Transcranial Magnetic Stimulation, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study is based on the characteristics of motor learning theory and motor learning neural network to improve motor function in stroke patients. This study is to investigate whether the cerebral-cerebellar repetitive transcranial magnetic stimulation (rTMS) is effective in improving motor function compared to the… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stroke, Repetitive Transcranial Magnetic Stimulation, rTMS
- What is being tested?
- Repetitive transcranial magnetic stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Oct 2020to 30 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemiplegic stroke patients within 1 month after onset
- Moderate to severe motor impairment (Fugl-Meyer assessment <85)
- Cognitive and language functions to perform more than one step of command
- More than 19 years old
Who cannot join
- Contraindicated to rTMS
- Progressive or unstable stroke
- Pre-existing and active major neurological disease or major psychiatric disease
- A history of advanced liver, kidney, cardiac or pulmonary disease, a terminal medical diagnosis consistent with survival <1 year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Cerebral and Cerebellar Repetitive Transcranial Magnetic Stimulation on Motor Function in Stroke Patients
This study is based on the characteristics of motor learning theory and motor learning neural network to improve motor function in stroke patients. This study is to investigate whether the cerebral-cerebellar repetitive transcranial magnetic stimulation (rTMS) is effective in improving motor function compared to the conventional cerebral rTMS in stroke patients.
- Being tested
- Repetitive transcranial magnetic stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulationProcedure or surgery
rTMS over cerebral motor cortex and cerebellar hemisphere
| Study group | Role | What they receive |
|---|---|---|
| Facilitatory cerebral and cerebellar rTMS group | Experimental | Patients underwent 10 consecutive daily sessions of high-frequency repetitive transcranial magnetic stimulation (rTMS) over the affected primary motor cortex of the hand and high-frequency rTMS over the ipsilateral cerebellar hemisphere. Receives: Procedure: Repetitive transcranial magnetic stimulation |
| Facilitatory cerebral rTMS group | Active comparator | Patients underwent 10 consecutive daily sessions of high-frequency repetitive transcranial magnetic stimulation (rTMS) over the affected primary motor cortex of the hand and sham high-frequency rTMS over the ipsilateral cerebellar hemisphere. Receives: Procedure: Repetitive transcranial magnetic stimulation |
| Inhibitory cerebral and cerebellar rTMS group | Experimental | Patients underwent 10 consecutive daily sessions of continous theta bust stimulation (cTBS) over the unaffected primary motor cortex of the hand and high-frequency rTMS over the ipsilateral cerebellar hemisphere. Receives: Procedure: Repetitive transcranial magnetic stimulation |
| Inhibitory cerebral rTMS group | Active comparator | Patients underwent 10 consecutive daily sessions of continous theta bust stimulation (cTBS) over the unaffected primary motor cortex of the hand and sham rTMS over the ipsilateral cerebellar hemisphere. Receives: Procedure: Repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of upper limb motor score in Fugl-Meyer assessment
(upper limb motor score in Fugl-Meyer assessment at post-intervention) - (upper limb motor score in Fugl-Meyer assessment at baseline)
Higher scores mean a better outcome
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start2 Oct 2020
- Primary completion31 Oct 2023
- Study completion30 Nov 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Hyuk Chang, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570774
- Sponsor's protocol ID
- 2020-06-068
- Status last verified
- Oct 2024
- First submitted
- 21 Sep 2020
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study will be available from the principal investigator upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cerebral and Cerebellar Repetitive Transcranial Magnetic Stimulation on Motor Function in Stroke Patients
- ClinicalTrials.gov ID
- NCT04570774
- Acronym / sponsor ID
- 2020-06-068
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 30 Sep 2020 (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.
This study is based on the characteristics of motor learning theory and motor learning neural network to improve motor function in stroke patients. This study is to investigate whether the cerebral-cerebellar repetitive transcranial magnetic stimulation (rTMS) is effective in improving motor function compared to the conventional cerebral rTMS in stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Facilitatory cerebral and cerebellar rTMS group | Experimental | Procedure: Repetitive transcranial magnetic stimulationPatients underwent 10 consecutive daily sessions of high-frequency repetitive transcranial magnetic stimulation (rTMS) over the affected primary motor cortex of the hand and high-frequency rTMS over the ipsilateral cerebellar hemisphere. |
| Facilitatory cerebral rTMS group | Active comparator | Procedure: Repetitive transcranial magnetic stimulationPatients underwent 10 consecutive daily sessions of high-frequency repetitive transcranial magnetic stimulation (rTMS) over the affected primary motor cortex of the hand and sham high-frequency rTMS over the ipsilateral cerebellar hemisphere. |
| Inhibitory cerebral and cerebellar rTMS group | Experimental | Procedure: Repetitive transcranial magnetic stimulationPatients underwent 10 consecutive daily sessions of continous theta bust stimulation (cTBS) over the unaffected primary motor cortex of the hand and high-frequency rTMS over the ipsilateral cerebellar hemisphere. |
| Inhibitory cerebral rTMS group | Active comparator | Procedure: Repetitive transcranial magnetic stimulationPatients underwent 10 consecutive daily sessions of continous theta bust stimulation (cTBS) over the unaffected primary motor cortex of the hand and sham rTMS over the ipsilateral cerebellar hemisphere. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hemiplegic stroke patients within 1 month after onset
- Moderate to severe motor impairment (Fugl-Meyer assessment <85)
- Cognitive and language functions to perform more than one step of command
- More than 19 years old
Key exclusion criteria (4 listed)
- Contraindicated to rTMS
- Progressive or unstable stroke
- Pre-existing and active major neurological disease or major psychiatric disease
- A history of advanced liver, kidney, cardiac or pulmonary disease, a terminal medical diagnosis consistent with survival <1 year
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 |
|---|---|---|
| Repetitive transcranial magnetic stimulationrTMS over cerebral motor cortex and cerebellar hemisphere | Procedure or surgery | Facilitatory cerebral and cerebellar rTMS group, Facilitatory cerebral rTMS group, Inhibitory cerebral and cerebellar rTMS group, Inhibitory cerebral rTMS group |
Primary outcome
Difference of upper limb motor score in Fugl-Meyer assessment
Time frame: 2 weeks
(upper limb motor score in Fugl-Meyer assessment at post-intervention) - (upper limb motor score in Fugl-Meyer assessment at baseline) Higher scores mean a better outcome
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 3 Oct 2024.
- Individual participant dataSharing planned: No. The data that support the findings of this study will be available from the principal investigator upon reasonable request.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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 Repetitive transcranial magnetic stimulation in people with Stroke and Repetitive Transcranial Magnetic Stimulation, 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 4 inclusion and 4 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 3 Oct 2024. 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?
Difference of upper limb motor score in Fugl-Meyer assessment (time frame: 2 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 3 Oct 2024.