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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05578183
• Other study ID #: HZhang
• Status: Withdrawn
• Phase: N/A
• Start date: December 31, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2022
• Source: China Rehabilitation Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Stroke
• Stroke Sequelae

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	China rehabilitation research center	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China Rehabilitation Research Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.