StrokeNCT05578183
Therapeutic Effect of Transcranial Magnetic Stimulation on Memory Impairment in Patients After Stroke
A study testing theta burst stimulation in people with Stroke and Stroke Sequelae, run by China Rehabilitation Research Center at 1 site in China.
Trial summary
The goal of this clinical trial is to test the therapeutic effect of theta burst stimulation (TBS), which is one of stimulus pattern of repetitive transcranial magnetic stimulation, in patients with post stroke cognition impairment (PSCI). The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke, Stroke Sequelae, Cognitive Impairment
- What is being tested?
- theta burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2022to 31 Dec 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First-time stroke patients, meeting the diagnostic criteria set by the Fourth National Conference of Cerebrovascular Diseases in 1995, and the course of stroke
- range from 1 to 12 months;
- The vital signs are stable and no progress in neurological signs;
- Education level: Primary school or above, and meeting one of the following conditions: MMSE scale ≥ 10 points, and indicating memory decline, with digit span or delayed memory defects.
- Patients or their family members sign the informed consent form.
Who cannot join
- Contraindications or high risks for TBS, such as epilepsy, intracranial metal implants, skull repair;
- Contraindications for fMRI, such as metal implants or claustrophobia; refuse fMRI;
- drug/alcohol dependence;
- Cognition or memory dysfunction before the onset;
- Patients who refuse to cooperate, or can't complete cognitive assessment due to other reasons, such as visual and auditory disturbance, aphasia, agnosia, apraxia.
Trial locations and contacts
1 site in 1 country.
China1 site
China rehabilitation research center
Beijing, Beijing Municipality, 100071
About this study
Official title: Therapeutic Efficacy and Mechanism of Personalized Theta Burst Stimulation on Working Memory Impairment in Patients After Stroke
The goal of this clinical trial is to test the therapeutic effect of theta burst stimulation (TBS), which is one of stimulus pattern of repetitive transcranial magnetic stimulation, in patients with post stroke cognition impairment (PSCI). The main questions it aims to answer are:
- To explore the therapeutic effect of TBS to patients with PSCI.
- To compare effect of TBS with different dose.
- To explore the mechanism of TBS by functional magnetic resonance imaging (fMRI).
Read more
Participants will be asked to do:
- Treated with TBS and cognitive training for 3 weeks (15 days).
- Assessed with several scales, including Mini-mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Loewenstein Occupational Therapy Cognitive Assessment (LOTCA), Wechsler Adult Intelligence Scale-revised in China (WAIS-RC), Wechsler Memory Scale (WMS) before and after treatment.
- Perform the resting fMRI, electroencephalogram (EEG) and event related potential before and after treatment.
Researchers will compare high-dose group, low-dose group and sham group to see if TBS play a role in PSCI and if the effect of high dose TBS was stronger than low dose.
Read the detailed description
the procedure of study
- Patients were recruited and agreed with Informed Consent.
- All patients were assessed with MMSE, MoCA, LOTCA, WAIS and WMS, meanwhile they conduct fMRI and EEG. Target of TBS set at dorsolateral prefrontal cortex (DLPFC).
- TBS was performed for 15 days (5 days * 3 weeks).
- Within 3 days after TBS, all patients were assessed with MMSE, MoCA, LOTCA, WAIS and WMS, meanwhile they conduct fMRI and EEG.
- Data acquisition and analysis.
- Conditions
- Stroke, Stroke Sequelae, Cognitive Impairment
- Being tested
- theta burst stimulation, sham stimulation
- Keywords
- stroke, cognitive impairment, transcranial magnetic stimulation, Functional Magnetic Resonance Imaging, event related potential
- Medical subject headings
- Stroke, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
theta burst stimulationDevice
Also called Cognitive training
expect for the TBS, all patients get cognitive training alike on a training system in medical center.
sham stimulationDevice
Also called Cognitive training
expect for the TBS, all patients get cognitive training alike on a training system in medical center.
| Study group | Role | What they receive |
|---|---|---|
| high dose TBS group | Experimental | parameters: pattern: intermittent TBS (iTBS; 2 seconds of TBS are delivered every 10 seconds), TBS consists of pulses applied in bursts of 3 at 50 Hz with an interburst interval at 5 Hz Receives: Device: theta burst stimulation |
| low dose TBS group | Experimental | parameters: pattern: intermittent TBS (iTBS; 2 seconds of TBS are delivered every 10 seconds), TBS consists of pulses applied in bursts of 3 at 50 Hz with an interburst interval at 5 Hz Receives: Device: theta burst stimulation |
| high dose sham TBS group | Sham comparator | parameters: pattern: intermittent TBS (iTBS; 2 seconds of TBS are delivered every 10 seconds), TBS consists of pulses applied in bursts of 3 at 50 Hz with an interburst interval at 5 Hz Receives: Device: sham stimulation |
| low dose sham TBS group | Sham comparator | parameters: pattern: intermittent TBS (iTBS; 2 seconds of TBS are delivered every 10 seconds), TBS consists of pulses applied in bursts of 3 at 50 Hz with an interburst interval at 5 Hz Receives: Device: sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Montreal Cognitive Assessment scale
one of the most used scales to assess cognition and screen person with cognitive impairment in the world. The minimum and maximum values range from 0 to 30. Higher score means better cognition level.
Measured: 1. finished in 3 days before TBS stimulation. 2. finished in 3 days after stimulation.
Secondary outcomes (1)
Change from Baseline Mini-mental State Examination scale
Easy to use and one of the most used scales to screen person with cognitive impairment in the world. The minimum and maximum values range from 0 to 30. Higher score means better cognition level.
Measured: 1. finished in 3 days before TBS stimulation. 2. finished in 3 days after stimulation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start31 Dec 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Why it stopped: The study has been registed in ChiCTR and apply for withdrawing.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Rehabilitation Research Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hao Zhang, China Rehabilitation Research Center
- Investigators
- Hao Zhang, Study director, China Rehabilitation Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578183
- Sponsor's protocol ID
- HZhang
- Status last verified
- Dec 2022
- First submitted
- 9 Oct 2022
- Last updated
- 8 Dec 2022
- 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 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Efficacy and Mechanism of Personalized Theta Burst Stimulation on Working Memory Impairment in Patients After Stroke
- ClinicalTrials.gov ID
- NCT05578183
- Acronym / sponsor ID
- HZhang
- Conditions
- Stroke, Stroke Sequelae, Cognitive Impairment
- Keywords
- stroke, cognitive impairment, transcranial magnetic stimulation, Functional Magnetic Resonance Imaging, event related potential
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study has been registed in ChiCTR and apply for withdrawing.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- China Rehabilitation Research CenterOther government
- Study start
- 31 Dec 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 13 Oct 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.
The goal of this clinical trial is to test the therapeutic effect of theta burst stimulation (TBS), which is one of stimulus pattern of repetitive transcranial magnetic stimulation, in patients with post stroke cognition impairment (PSCI). The main questions it aims to answer are:
- To explore the therapeutic effect of TBS to patients with PSCI.
- To compare effect of TBS with different dose.
- To explore the mechanism of TBS by functional magnetic resonance imaging (fMRI).
Participants will be asked to do:
- Treated with TBS and cognitive training for 3 weeks (15 days).
- Assessed with several scales, including Mini-mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Loewenstein Occupational Therapy Cognitive Assessment (LOTCA), Wechsler Adult Intelligence Scale-revised in China (WAIS-RC), Wechsler Memory Scale (WMS) before and after treatment.
- Perform the resting fMRI, electroencephalogram (EEG) and event related potential before and after treatment.
Researchers will compare high-dose group, low-dose group and sham group to see if TBS play a role in PSCI and if the effect of high dose TBS was stronger than low dose.
Detailed description
the procedure of study
- Patients were recruited and agreed with Informed Consent.
- All patients were assessed with MMSE, MoCA, LOTCA, WAIS and WMS, meanwhile they conduct fMRI and EEG. Target of TBS set at dorsolateral prefrontal cortex (DLPFC).
- TBS was performed for 15 days (5 days * 3 weeks).
- Within 3 days after TBS, all patients were assessed with MMSE, MoCA, LOTCA, WAIS and WMS, meanwhile they conduct fMRI and EEG.
- Data acquisition and analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| high dose TBS group | Experimental | Device: theta burst stimulationparameters: pattern: intermittent TBS (iTBS; 2 seconds of TBS are delivered every 10 seconds), TBS consists of pulses applied in bursts of 3 at 50 Hz with an interburst interval at 5 Hz |
| low dose TBS group | Experimental | Device: theta burst stimulationparameters: pattern: intermittent TBS (iTBS; 2 seconds of TBS are delivered every 10 seconds), TBS consists of pulses applied in bursts of 3 at 50 Hz with an interburst interval at 5 Hz |
| high dose sham TBS group | Sham comparator | Device: sham stimulationparameters: pattern: intermittent TBS (iTBS; 2 seconds of TBS are delivered every 10 seconds), TBS consists of pulses applied in bursts of 3 at 50 Hz with an interburst interval at 5 Hz |
| low dose sham TBS group | Sham comparator | Device: sham stimulationparameters: pattern: intermittent TBS (iTBS; 2 seconds of TBS are delivered every 10 seconds), TBS consists of pulses applied in bursts of 3 at 50 Hz with an interburst interval at 5 Hz |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- First-time stroke patients, meeting the diagnostic criteria set by the Fourth National Conference of Cerebrovascular Diseases in 1995, and the course of stroke
- range from 1 to 12 months;
- The vital signs are stable and no progress in neurological signs;
- Education level: Primary school or above, and meeting one of the following conditions: MMSE scale ≥ 10 points, and indicating memory decline, with digit span or delayed memory defects.
- Patients or their family members sign the informed consent form.
Key exclusion criteria (5 listed)
- Contraindications or high risks for TBS, such as epilepsy, intracranial metal implants, skull repair;
- Contraindications for fMRI, such as metal implants or claustrophobia; refuse fMRI;
- drug/alcohol dependence;
- Cognition or memory dysfunction before the onset;
- Patients who refuse to cooperate, or can't complete cognitive assessment due to other reasons, such as visual and auditory disturbance, aphasia, agnosia, apraxia.
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 |
|---|---|---|
| theta burst stimulationAlso: Cognitive trainingexpect for the TBS, all patients get cognitive training alike on a training system in medical center. | Device | high dose TBS group, low dose TBS group |
| sham stimulationAlso: Cognitive trainingexpect for the TBS, all patients get cognitive training alike on a training system in medical center. | Device | high dose sham TBS group, low dose sham TBS group |
Primary outcome
Change from Baseline Montreal Cognitive Assessment scale
Time frame: 1. finished in 3 days before TBS stimulation. 2. finished in 3 days after stimulation.
one of the most used scales to assess cognition and screen person with cognitive impairment in the world. The minimum and maximum values range from 0 to 30. Higher score means better cognition level.
1 secondary outcome
Change from Baseline Mini-mental State Examination scale
Time frame: 1. finished in 3 days before TBS stimulation. 2. finished in 3 days after stimulation.
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 8 Dec 2022.
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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.
Hao Zhang study director
China Rehabilitation Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing theta burst stimulation in people with Stroke and Stroke Sequelae, run by China Rehabilitation Research Center at 1 site in China.
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 5 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 8 Dec 2022. 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 China. 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. Some participants in this study may receive a placebo. 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?
Change from Baseline Montreal Cognitive Assessment scale (time frame: 1. finished in 3 days before TBS stimulation. 2. finished in 3 days after stimulation.). 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 8 Dec 2022; AzTrials last refreshed its copy on 8 Nov 2026.