StrokeNCT03828435
Individualized rTMS Protocol for Stroke Recovery
A study testing rTMS in people with Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This study aims to develop individualized therapeutic protocol to improve stroke recovery and fits the scheme of Mechanisms, biomarkers, and treatment strategies for stroke, aging, and Parkinson's disease by advanced EEG analysis and transcranial magnetic stimulation technique. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2016to Dec 2019
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- first-ever stroke
- in subacute stage (between 1-3 months after stroke onset)
- monohemispheric ischemic stroke
- able to follow the command of the shoulder flexion
- mild to moderate paresis in the upper limb (the motor arm score of National Institute of Health Stroke Scale (NIHSS) = 1 \& 2 out of 4, where 4 = no movement)
Who cannot join
- being less than 20 years or over 75 years of age
- history of seizures or epileptiform discharges on electroencephalogram (EEG)
- pregnancy
- aphasia, apraxia, and concomitant neurological diseases or other severe medical diseases (e.g., sepsis, malignancy, hepatic or renal failure).
- having a pacemaker, an implanted medication pump, a metal plate in the skull, or metal objects inside the eye or skull (for example after brain surgery or a shrapnel wound)
- taking tricyclic antidepressants, neuroleptic agents and other drugs that lower the seizure threshold
- Insulin dependent diabetes
- Thyroid disease
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Ying-Zu Huang
Taoyuan, 333
Ying-Zu Huang, MD, PhD
CC Chen
About this study
Official title: Development and Efficacy Evaluation of Individualized rTMS Protocol for Stroke Recovery
This study aims to develop individualized therapeutic protocol to improve stroke recovery and fits the scheme of Mechanisms, biomarkers, and treatment strategies for stroke, aging, and Parkinson's disease by advanced EEG analysis and transcranial magnetic stimulation technique.
Read the detailed description
It has long been a challenge to promote the recovery after stroke. So far, rehabilitation has been the most evident way for this purpose, while pharmacological approaches have done very little.
However, the unsatisfied results urge us to recognize the need of new therapeutic solutions for stroke recovery. In the past few years, the development of non-invasive brain stimulation techniques, which are capable of altering the brain excitability through plasticity-like mechanisms for up to an hour or so, lead to the expectation of improving the recovery of stroke and other neurological disorders by manipulation neuroplasticity. Nevertheless, even with the help of brain stimulation, the results in stroke recovery are diverse and limited, although most studies agree that non-invasive brain stimulation, including repetitive transcranial magnetic stimulation (rTMS) is beneficial to the recovery after stroke.
Therefore, it is an important topic to ameliorate the recipe of brain stimulation for stroke recovery to improve its efficiency and efficacy. Facing this challenge, the investigators designed this study to develop individualized rTMS protocol for stroke recovery, to verify the predictor of stroke outcome discovered by DCM and to explore factors that cause the variability of rTMS. Based on our recent findings that revealed key patterns of stroke recovery base in EEG-based EEG based dynamic causal modelling (DCM), the individualize TMS protocol will be developed. The investigators will first apply different protocols of rTMS given to a variety of locations within the motor network to evaluate their effects on the DCM network. The results will be used for selecting proper rTMS protocols for stroke patients based on their DCM results. The effect of the individualized rTMS protocol will be tested in a small group of patient first. Then the longer therapeutic effect of the protocol will be assessed in a larger patient group under a double-blinded randomized control basis. With the help of this project, the investigators will be able to understand how different protocols of rTMS given to a variety of locations within the motor network affect the DCM network. Such information will be useful for developing individualized rTMS protocol for not only stroke therapy in the present study, but also other neurological disorders, e.g. Parkinson's disease and dystonia, in the further studies.
Furthermore, the investigators expect that the patients stimulated with rTMS using the protocol matched to their DCM network will recover better than those treated with unmatched protocol. This part of result could be further applied as a clinical application to facilitate stroke recovery. The predictors for stroke recovery revealed by the DCM model will also be verified in the current project. This will give us more information about the accuracy of the predictors and may give us new insights for the further development of stroke therapy. The investigators will further analyze EEG data and the results to provide knowledge of the state-dependent effect of brain on the variability of the current forms of rTMS and other noninvasive brain stimulation. This part of information will be very helpful for developing the strategy for eliminating the variability of rTMS and for improving the protocol of rTMS to be more powerful and efficient.
- Conditions
- Stroke
- Being tested
- rTMS
- Keywords
- patient
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
Magnetic stimulation will be given using a hand-held figure-of-eight coil with an median winding diameter of 70 mm or a cone coil (Magstim Co., Whitland, Dyfed, UK) connected to one Magstim Rapid2 Package (Magstim Co., UK). The figure-of-eight coil will be placed tangentially to the scalp with the handle pointing backwards, which is thought to preferentially activate the corticospinal cells trans-synaptically (Kaneko et al., 1996), while the cone coil will be placed along the anterioposterior axis to induce a posterior-to-anterior current in the cortex.
| Study group | Role | What they receive |
|---|---|---|
| healthy control | Experimental | This group does not undergo any treatment . Intervention : rTMS Receives: Device: rTMS |
| stroke patient | Experimental | this group undergoes rehabilitative therapy. It is a 24-week program and stroke patients practice the physical exercise for 1 hour each time. The intensity is three times a week.
Intervention : rTMS Receives: Device: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of Fugl-Meyer Assessment of Physical Performance (FM)
a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia
Measured: upon recruitment, after 24 weeks of rehabilitation treatment
The changes of upper extremity performance evaluation test for the elderly (TEMPA)
a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia
Measured: upon recruitment, after 24 weeks of rehabilitation treatment
The changes of Wolf Motor Function Test (WMFT)
a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia
Measured: upon recruitment, after 24 weeks of rehabilitation treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study startApr 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (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.
- 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
- Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828435
- Sponsor's protocol ID
- 104-2292A3
- Status last verified
- Jan 2019
- First submitted
- 27 Jan 2016
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Efficacy Evaluation of Individualized rTMS Protocol for Stroke Recovery
- ClinicalTrials.gov ID
- NCT03828435
- Acronym / sponsor ID
- 104-2292A3
- Conditions
- Stroke
- Keywords
- patient
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 4 Feb 2019 (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 aims to develop individualized therapeutic protocol to improve stroke recovery and fits the scheme of Mechanisms, biomarkers, and treatment strategies for stroke, aging, and Parkinson's disease by advanced EEG analysis and transcranial magnetic stimulation technique.
Detailed description
It has long been a challenge to promote the recovery after stroke. So far, rehabilitation has been the most evident way for this purpose, while pharmacological approaches have done very little.
However, the unsatisfied results urge us to recognize the need of new therapeutic solutions for stroke recovery. In the past few years, the development of non-invasive brain stimulation techniques, which are capable of altering the brain excitability through plasticity-like mechanisms for up to an hour or so, lead to the expectation of improving the recovery of stroke and other neurological disorders by manipulation neuroplasticity. Nevertheless, even with the help of brain stimulation, the results in stroke recovery are diverse and limited, although most studies agree that non-invasive brain stimulation, including repetitive transcranial magnetic stimulation (rTMS) is beneficial to the recovery after stroke.
Therefore, it is an important topic to ameliorate the recipe of brain stimulation for stroke recovery to improve its efficiency and efficacy. Facing this challenge, the investigators designed this study to develop individualized rTMS protocol for stroke recovery, to verify the predictor of stroke outcome discovered by DCM and to explore factors that cause the variability of rTMS. Based on our recent findings that revealed key patterns of stroke recovery base in EEG-based EEG based dynamic causal modelling (DCM), the individualize TMS protocol will be developed. The investigators will first apply different protocols of rTMS given to a variety of locations within the motor network to evaluate their effects on the DCM network. The results will be used for selecting proper rTMS protocols for stroke patients based on their DCM results. The effect of the individualized rTMS protocol will be tested in a small group of patient first. Then the longer therapeutic effect of the protocol will be assessed in a larger patient group under a double-blinded randomized control basis. With the help of this project, the investigators will be able to understand how different protocols of rTMS given to a variety of locations within the motor network affect the DCM network. Such information will be useful for developing individualized rTMS protocol for not only stroke therapy in the present study, but also other neurological disorders, e.g. Parkinson's disease and dystonia, in the further studies.
Furthermore, the investigators expect that the patients stimulated with rTMS using the protocol matched to their DCM network will recover better than those treated with unmatched protocol. This part of result could be further applied as a clinical application to facilitate stroke recovery. The predictors for stroke recovery revealed by the DCM model will also be verified in the current project. This will give us more information about the accuracy of the predictors and may give us new insights for the further development of stroke therapy. The investigators will further analyze EEG data and the results to provide knowledge of the state-dependent effect of brain on the variability of the current forms of rTMS and other noninvasive brain stimulation. This part of information will be very helpful for developing the strategy for eliminating the variability of rTMS and for improving the protocol of rTMS to be more powerful and efficient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy control | Experimental | Device: rTMSThis group does not undergo any treatment . Intervention : rTMS |
| stroke patient | Experimental | Device: rTMSthis group undergoes rehabilitative therapy. It is a 24-week program and stroke patients practice the physical exercise for 1 hour each time. The intensity is three times a week. Intervention : rTMS |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- first-ever stroke
- in subacute stage (between 1-3 months after stroke onset)
- monohemispheric ischemic stroke
- able to follow the command of the shoulder flexion
- mild to moderate paresis in the upper limb (the motor arm score of National Institute of Health Stroke Scale (NIHSS) = 1 \& 2 out of 4, where 4 = no movement)
Key exclusion criteria (8 listed)
- being less than 20 years or over 75 years of age
- history of seizures or epileptiform discharges on electroencephalogram (EEG)
- pregnancy
- aphasia, apraxia, and concomitant neurological diseases or other severe medical diseases (e.g., sepsis, malignancy, hepatic or renal failure).
- having a pacemaker, an implanted medication pump, a metal plate in the skull, or metal objects inside the eye or skull (for example after brain surgery or a shrapnel wound)
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 |
|---|---|---|
| rTMSMagnetic stimulation will be given using a hand-held figure-of-eight coil with an median winding diameter of 70 mm or a cone coil (Magstim Co., Whitland, Dyfed, UK) connected to one Magstim Rapid2 Package (Magstim Co., UK). The figure-of-eight coil will be placed tangentially to the scalp with the handle pointing backwards, which is thought to preferentially activate the corticospinal cells trans-synaptically (Kaneko et al., 1996), while the cone coil will be placed along the anterioposterior axis to induce a posterior-to-anterior current in the cortex. | Device | healthy control, stroke patient |
Primary outcome
The changes of Fugl-Meyer Assessment of Physical Performance (FM)
Time frame: upon recruitment, after 24 weeks of rehabilitation treatment
a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia
The changes of upper extremity performance evaluation test for the elderly (TEMPA)
Time frame: upon recruitment, after 24 weeks of rehabilitation treatment
a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia
The changes of Wolf Motor Function Test (WMFT)
Time frame: upon recruitment, after 24 weeks of rehabilitation treatment
a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with Stroke, run by Chang Gung Memorial 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 5 inclusion and 8 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 4 Feb 2019. 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 Ying-Zu Huang, MD, PhD (+886 3 3281200 ext. 3775, yzhuang@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of Fugl-Meyer Assessment of Physical Performance (FM) (time frame: upon recruitment, after 24 weeks of rehabilitation treatment). The study lists 3 primary outcomes in all. 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 4 Feb 2019; AzTrials last refreshed its copy on 31 Oct 2026.