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

Not Applicable

Withdrawn

• Conditions: Stroke Sequelae; Cognitive Impairment; Stroke
• Interventions: Device: sham stimulation; Device: theta burst stimulation

• Registration Number: NCT05578183
• Lead Sponsor: China Rehabilitation Research Center

Brief 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. 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.

Detailed Description

the procedure of study

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.

Study Timeline

• Study First Submitted: 2022-10-09
• Study First Submitted QC: 2022-10-12
• Study First Posted: 2022-10-13
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-07
• Last Update Posted: 2022-12-08
• Study Start: 2022-12-31
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high dose sham TBS group	sham stimulation	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
low dose sham TBS group	sham stimulation	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
low dose TBS group	theta burst stimulation	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
high dose TBS group	theta burst stimulation	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

Primary Outcome Measures

Name	Time	Method
Change from Baseline Montreal Cognitive Assessment scale	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.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Mini-mental State Examination scale	1. finished in 3 days before TBS stimulation. 2. finished in 3 days after stimulation.	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.

Trial Locations

Locations (1)

China rehabilitation research center; 🇨🇳 Beijing, Beijing, China