Therapeutic Effect of Transcranial Magnetic Stimulation on Memory Impairment in Patients After Stroke

Study Overview
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Brief Summary
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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
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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.

Official Title
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Therapeutic Efficacy and Mechanism of Personalized Theta Burst Stimulation on Working Memory Impairment in Patients After Stroke

Conditions
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Stroke, Stroke Sequelae, Cognitive Impairment

Intervention / Treatment
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* Device: theta burst stimulation
* Device: sham stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high dose TBS group<br>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 | Device: theta burst stimulation<br>* expect for the TBS, all patients get cognitive training alike on a training system in medical center.<br>* Other names: Cognitive training;|
| Experimental: low dose TBS group<br>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 | Device: theta burst stimulation<br>* expect for the TBS, all patients get cognitive training alike on a training system in medical center.<br>* Other names: Cognitive training;|
| Sham Comparator: high dose sham TBS group<br>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 | Device: sham stimulation<br>* expect for the TBS, all patients get cognitive training alike on a training system in medical center.<br>* Other names: Cognitive training;|
| Sham Comparator: low dose sham TBS group<br>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 | Device: sham stimulation<br>* expect for the TBS, all patients get cognitive training alike on a training system in medical center.<br>* Other names: Cognitive training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1. finished in 3 days before TBS stimulation. 2. finished in 3 days after stimulation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1. finished in 3 days before TBS stimulation. 2. finished in 3 days after stimulation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, cognitive impairment, transcranial magnetic stimulation, Functional Magnetic Resonance Imaging, event related potential