StrokeNCT05914038
Individualized rTMS for Motor Recovery in Stroke Patients
A study testing Repetitive transcranial magnetic stimulation in people with Stroke and Transcranial Magnetic Stimulation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study aimed to aim to investigate the efficacy of individualized rTMS according to lateralization index on motor recovery and cortical excitability in subacute stroke patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke, Transcranial Magnetic Stimulation
- What is being tested?
- Repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Oct 2023to 20 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral ischemic or hemorrhagic stroke
- Stroke within 3 months
- Medical Research Council Scale for Muscle Strength in upper limb ≤ 3
- No previous stroke, seizure, dementia, Parkinson's disease or other degenerative neurological diseases.
- Patient could sit over 15 minutes
- Age over 20
Who cannot join
- Previous stroke, traumatic brain injury, brain tumor
- With central nervous system disease (spinal cord injury, Parkinson's disease)
- Any contraindication to rTMS (seizure, alcoholism, metal implant, pacemaker)
- Patients unable to cooperate the treatment
- Pregnancy
- Depression
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei County, Taipei, 100
Meng Ting Lin, M.D., 0223123456 ext. 67651, b96401093@gmail.com
About this study
Official title: Efficacy of Individualized Repetitive Transcranial Magnetic Stimulation Based on Cortical Laterality for Motor Recovery in Stroke Patients
This study aimed to aim to investigate the efficacy of individualized rTMS according to lateralization index on motor recovery and cortical excitability in subacute stroke patients.
Read the detailed description
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology.
High and low frequencies of rTMS could modulate the excitability of the cerebral cortex. Theta burst stimulation (TBS) has achieved a similar effect to traditional rTMS mode.
However, the current rTMS studies for stroke patients utilized the same therapeutic protocol and there is no individualized rTMS protocol based on the value of lateralization index.
This study aimed to aim to investigate the efficacy of individualized rTMS according to lateralization index on motor recovery and cortical excitability in subacute stroke patients.
- Conditions
- Stroke, Transcranial Magnetic Stimulation
- 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 stimulationDevice
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology. High and low frequencies of rTMS could modulate the excitability of the cerebral cortex.
| Study group | Role | What they receive |
|---|---|---|
| individualized rTMS | Experimental | Patients will receive individualized repetitive transcranial magnetic stimulation according to lateralization index measured by functional near-infrared spectroscopy Receives: Device: Repetitive transcranial magnetic stimulation |
| Traditional rTMS | Active comparator | Control group is given traditional rTMS Receives: Device: Repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment
Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.
Measured: 12 weeks post intervention
Secondary outcomes (7)
Medical Research Council (MRC) Scale for Muscle Strength
Medical Research Council (MRC) Scale for Muscle Strength, assessing muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction).
Measured: 1 week, 4 weeks, 12 weeks post intervention
National Institutes of Health Stroke Scale
National Institutes of Health Stroke Scale, The maximum possible score is 42, with the minimum score being a 0. Higher scores indicate a worse outcome.
Measured: 1 week, 4 weeks, 12 weeks post intervention
Barthel Index
Barthel Index, score 100-0. Higher scores indicate a better outcome.
Measured: 1 week, 4 weeks, 12 weeks post intervention
Modified Rankin Scale
Modified Rankin Scale, score from 0 to 6. Higher scores indicate a worse outcome.
Measured: 1 week, 4 weeks, 12 weeks post intervention
MEP
motor evoked potential
Measured: 1 week, 4 weeks, 12 weeks post intervention
Fugl-Meyer Assessment
Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.
Measured: 1 week, 4 weeks post intervention
functional NIRS
Functional Near Infrared Spectroscopy to detect the cortical excitability
Measured: 1 week, 4 weeks, 12 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start13 Oct 2023
- Primary completion20 May 2025 (estimated)
- Study completion20 May 2027 (estimated)
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 National Taiwan University HospitalThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meng Ting Lin, M.D., Principal investigator, The Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914038
- Sponsor's protocol ID
- 202301225DIND
- Status last verified
- Oct 2024
- First submitted
- 13 Jun 2023
- Last updated
- 18 Oct 2024
- 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 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Individualized Repetitive Transcranial Magnetic Stimulation Based on Cortical Laterality for Motor Recovery in Stroke Patients
- ClinicalTrials.gov ID
- NCT05914038
- Acronym / sponsor ID
- 202301225DIND
- Conditions
- Stroke, Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- 20 May 2025 (estimated)
- Study completion
- 20 May 2027 (estimated)
- First posted
- 22 Jun 2023 (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 aimed to aim to investigate the efficacy of individualized rTMS according to lateralization index on motor recovery and cortical excitability in subacute stroke patients.
Detailed description
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology.
High and low frequencies of rTMS could modulate the excitability of the cerebral cortex. Theta burst stimulation (TBS) has achieved a similar effect to traditional rTMS mode.
However, the current rTMS studies for stroke patients utilized the same therapeutic protocol and there is no individualized rTMS protocol based on the value of lateralization index.
This study aimed to aim to investigate the efficacy of individualized rTMS according to lateralization index on motor recovery and cortical excitability in subacute stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| individualized rTMS | Experimental | Device: Repetitive transcranial magnetic stimulationPatients will receive individualized repetitive transcranial magnetic stimulation according to lateralization index measured by functional near-infrared spectroscopy |
| Traditional rTMS | Active comparator | Device: Repetitive transcranial magnetic stimulationControl group is given traditional rTMS |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Unilateral ischemic or hemorrhagic stroke
- Stroke within 3 months
- Medical Research Council Scale for Muscle Strength in upper limb ≤ 3
- No previous stroke, seizure, dementia, Parkinson's disease or other degenerative neurological diseases.
- Patient could sit over 15 minutes
Key exclusion criteria (6 listed)
- Previous stroke, traumatic brain injury, brain tumor
- With central nervous system disease (spinal cord injury, Parkinson's disease)
- Any contraindication to rTMS (seizure, alcoholism, metal implant, pacemaker)
- Patients unable to cooperate the treatment
- Pregnancy
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 stimulationRepetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology. High and low frequencies of rTMS could modulate the excitability of the cerebral cortex. | Device | Traditional rTMS, individualized rTMS |
Primary outcome
Fugl-Meyer Assessment
Time frame: 12 weeks post intervention
Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.
7 secondary outcomes
Medical Research Council (MRC) Scale for Muscle Strength
Time frame: 1 week, 4 weeks, 12 weeks post intervention
National Institutes of Health Stroke Scale
Time frame: 1 week, 4 weeks, 12 weeks post intervention
Barthel Index
Time frame: 1 week, 4 weeks, 12 weeks post intervention
Modified Rankin Scale
Time frame: 1 week, 4 weeks, 12 weeks post intervention
MEP
Time frame: 1 week, 4 weeks, 12 weeks post intervention
Fugl-Meyer Assessment
Time frame: 1 week, 4 weeks post intervention
functional NIRS
Time frame: 1 week, 4 weeks, 12 weeks post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Meng Ting Lin, M.D. principal investigator
The Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
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 Transcranial Magnetic Stimulation, run by National Taiwan University Hospital at 1 site in Taiwan.
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 6 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: looking for participants now, as of the sponsor's last update on 18 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meng Ting Lin, M.D. (+886-2312-3456 ext. 67048, b96401093@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment (time frame: 12 weeks post intervention). 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 18 Oct 2024.