Therapeutic Effect of Transcranial Magnetic Stimulation on Memory Impairment in Patients After Stroke
NCT ID: NCT05578183
Last Updated: 2022-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2022-12-31
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
1. To explore the therapeutic effect of TBS to patients with PSCI.
2. To compare effect of TBS with different dose.
3. To explore the mechanism of TBS by functional magnetic resonance imaging (fMRI).
Participants will be asked to do:
1. Treated with TBS and cognitive training for 3 weeks (15 days).
2. 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.
3. 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Network-targeted Theta-burst Stimulation for Episodic Memory Improvement in Mild Cognitive Impairment
NCT04558164
Intermittent Theta-burst Stimulation for Mild Cognitive Impairment
NCT06608316
Cognitive Effects and Potential Mechanisms of TBS in Subjects With MCI
NCT05448768
Strategy Based Technique to Enhance Memory (STEM) for Improving New Learning and Memory (NLM) in Moderate to Severe TBI
NCT04054596
Effects of Transcranial Direct Current Stimulation After Short-term Immobilization on Motor Learning and Hand Function in Healthy Young Adults
NCT07089056
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. Patients were recruited and agreed with Informed Consent.
2. 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).
3. TBS was performed for 15 days (5 days \* 3 weeks).
4. Within 3 days after TBS, all patients were assessed with MMSE, MoCA, LOTCA, WAIS and WMS, meanwhile they conduct fMRI and EEG.
5. Data acquisition and analysis.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
high dose TBS group
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
theta burst stimulation
expect for the TBS, all patients get cognitive training alike on a training system in medical center.
low dose TBS group
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
theta burst stimulation
expect for the TBS, all patients get cognitive training alike on a training system in medical center.
high dose sham TBS group
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
sham stimulation
expect for the TBS, all patients get cognitive training alike on a training system in medical center.
low dose sham TBS group
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
sham stimulation
expect for the TBS, all patients get cognitive training alike on a training system in medical center.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
theta burst stimulation
expect for the TBS, all patients get cognitive training alike on a training system in medical center.
sham stimulation
expect for the TBS, all patients get cognitive training alike on a training system in medical center.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
China Rehabilitation Research Center
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hao Zhang
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hao Zhang
Role: STUDY_DIRECTOR
China Rehabilitation Research Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
China rehabilitation research center
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HZhang
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.