Transcranial Magnetic StimulationNCT05613686
Theta Burst Stimulation for Motor Recovery
A study testing repetitive transcranial magnetic stimulation in people with Transcranial Magnetic Stimulation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology. This study will compare efficacy of different doses iTBS in combination with inhibitory rTMS 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
- 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
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Oct 2022to 29 Oct 2024
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Unilateral ischemic or hemorrhagic stroke
- 2.Stroke within 3 months
- 3.Medical Research Council Scale for Muscle Strength in upper limb ≤ 3
- 4.No previous stroke, seizure, dementia, Parkinson's disease or other degenerative neurological diseases.
- 5.Patient could sit over 15 minutes
- 6.Age over 20
Who cannot join
- 1.Previous stroke, traumatic brain injury, brain tumor
- 2.With central nervous system disease (spinal cord injury, Parkinson's disease)
- 3.Any contraindication to rTMS (seizure, alcoholism, metal implant, pacemaker)
- 4.Patients unable to cooperate the treatment
- 5.Pregnancy
- 6.Depression
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Meng Ting Lin, M.D., +886-2312-3456, b96401093@ntu.edu.tw
About this study
Official title: Comparative Efficacy of Different Doses of Theta Burst Stimulation for Motor Recovery in Stroke Patients
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology. This study will compare efficacy of different doses iTBS in combination with inhibitory rTMS 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. Intermittent TBS (iTBS) could upregulate cortical excitability of the primary motor cortex (M1) and continuous TBS (cTBS) with inhibitory effect. Through modulating the excitability of bilateral hemispheres, rTMS could facilitate motor recovery in stroke patients.
This study will compare efficacy of different doses iTBS in combination with inhibitory rTMS on motor recovery and cortical excitability in subacute stroke patients.
- Conditions
- Transcranial Magnetic Stimulation
- Being tested
- repetitive transcranial magnetic stimulation
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. Theta burst stimulation (TBS) has achieved a similar effect to traditional rTMS mode. Intermittent TBS (iTBS) could upregulate cortical excitability of the primary motor cortex (M1) and continuous TBS (cTBS) with inhibitory effect.
| Study group | Role | What they receive |
|---|---|---|
| contralateral 1Hz+ipsilateral iTBS 1 | Experimental | Patients received contralateral 1 Hz and ipsilateral iTBS with protocol 1 Receives: Device: repetitive transcranial magnetic stimulation |
| contralateral 1Hz+ipsilateral iTBS 2 | Experimental | Patients received contralateral 1 Hz and ipsilateral iTBS with protocol 2 Receives: Device: repetitive transcranial magnetic stimulation |
| contralateral 1Hz | Active comparator | Patients received contralateral 1 Hz and ipsilateral sham iTBS 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 (8)
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 and 24 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 and 24 weeks post intervention
Barthel Index
Barthel Index, score 100-0. Higher scores indicate a better outcome.
Measured: 1 week, 4 weeks, 12 weeks and 24 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 and 24 weeks post intervention
MEP
motor evoked potential
Measured: 1 week, 4 weeks, 12 weeks and 24 weeks post intervention
Fugl-Meyer Assessment
Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.
Measured: 1 week post intervention
Fugl-Meyer Assessment
Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.
Measured: 4 weeks post intervention
Fugl-Meyer Assessment
Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.
Measured: 24 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 posted14 Nov 2022
- Study start29 Oct 2022
- Primary completion29 Oct 2024 (estimated)
- Study completion29 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transcranial Magnetic StimulationStudies 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
- 60 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
- NCT05613686
- Sponsor's protocol ID
- 202204105DINB
- Status last verified
- Aug 2024
- First submitted
- 30 Oct 2022
- Last updated
- 19 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: will make further analysis
Publications
Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.
PubMed 31901449
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Different Doses of Theta Burst Stimulation for Motor Recovery in Stroke Patients
- ClinicalTrials.gov ID
- NCT05613686
- Acronym / sponsor ID
- 202204105DINB
- Conditions
- Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 29 Oct 2022 (actual)
- Primary completion
- 29 Oct 2024 (estimated)
- Study completion
- 29 Oct 2024 (estimated)
- First posted
- 14 Nov 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.
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology. This study will compare efficacy of different doses iTBS in combination with inhibitory rTMS 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. Intermittent TBS (iTBS) could upregulate cortical excitability of the primary motor cortex (M1) and continuous TBS (cTBS) with inhibitory effect. Through modulating the excitability of bilateral hemispheres, rTMS could facilitate motor recovery in stroke patients.
This study will compare efficacy of different doses iTBS in combination with inhibitory rTMS 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
- 3
| Arm | Type | Receives |
|---|---|---|
| contralateral 1Hz+ipsilateral iTBS 1 | Experimental | Device: repetitive transcranial magnetic stimulationPatients received contralateral 1 Hz and ipsilateral iTBS with protocol 1 |
| contralateral 1Hz+ipsilateral iTBS 2 | Experimental | Device: repetitive transcranial magnetic stimulationPatients received contralateral 1 Hz and ipsilateral iTBS with protocol 2 |
| contralateral 1Hz | Active comparator | Device: repetitive transcranial magnetic stimulationPatients received contralateral 1 Hz and ipsilateral sham iTBS |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1.Unilateral ischemic or hemorrhagic stroke
- 2.Stroke within 3 months
- 3.Medical Research Council Scale for Muscle Strength in upper limb ≤ 3
- 4.No previous stroke, seizure, dementia, Parkinson's disease or other degenerative neurological diseases.
- 5.Patient could sit over 15 minutes
Key exclusion criteria (6 listed)
- 1.Previous stroke, traumatic brain injury, brain tumor
- 2.With central nervous system disease (spinal cord injury, Parkinson's disease)
- 3.Any contraindication to rTMS (seizure, alcoholism, metal implant, pacemaker)
- 4.Patients unable to cooperate the treatment
- 5.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. Theta burst stimulation (TBS) has achieved a similar effect to traditional rTMS mode. Intermittent TBS (iTBS) could upregulate cortical excitability of the primary motor cortex (M1) and continuous TBS (cTBS) with inhibitory effect. | Device | contralateral 1Hz, contralateral 1Hz+ipsilateral iTBS 1, contralateral 1Hz+ipsilateral iTBS 2 |
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.
8 secondary outcomes
Medical Research Council (MRC) Scale for Muscle Strength
Time frame: 1 week, 4 weeks, 12 weeks and 24 weeks post intervention
National Institutes of Health Stroke Scale
Time frame: 1 week, 4 weeks, 12 weeks and 24 weeks post intervention
Barthel Index
Time frame: 1 week, 4 weeks, 12 weeks and 24 weeks post intervention
Modified Rankin Scale
Time frame: 1 week, 4 weeks, 12 weeks and 24 weeks post intervention
MEP
Time frame: 1 week, 4 weeks, 12 weeks and 24 weeks post intervention
Fugl-Meyer Assessment
Time frame: 1 week post intervention
Fugl-Meyer Assessment
Time frame: 4 weeks post intervention
Fugl-Meyer Assessment
Time frame: 24 weeks post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Background: PubMed 31901449Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.
- Individual participant dataSharing planned: No. will make further analysis
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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.
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 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: status not confirmed, as of the sponsor's last update on 19 Aug 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?
Results are not available in the source record.
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?
On the ClinicalTrials.gov record for NCT05613686, which also lists 1 linked publication.
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 19 Aug 2024.