Clinical trial NCT05578183: Therapeutic Effect of Transcranial Magnetic Stimulation on Memory Impairment in Patients After Stroke
Official title: Therapeutic Efficacy and Mechanism of Personalized Theta Burst Stimulation on Working Memory Impairment in Patients After Stroke
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke
Stroke Sequelae
Cognitive Impairment
Keywords: stroke
cognitive impairment
transcranial magnetic stimulation
Functional Magnetic Resonance Imaging
event related potential
Lead sponsor: China Rehabilitation Research Center
Sponsor class: OTHER_GOV
First posted: 2022-10-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline Montreal Cognitive Assessment scale
timeFrame: 1. finished in 3 days before TBS stimulation. 2. finished in 3 days after stimulation.
Secondary outcomes:
measure: Change from Baseline Mini-mental State Examination scale
timeFrame: 1. finished in 3 days before TBS stimulation. 2. finished in 3 days after stimulation.
Other outcomes:
Locations:
city: Beijing
country: China
facility: China rehabilitation research center
state: Beijing
Study officials:
affiliation: China Rehabilitation Research Center
name: Hao Zhang
role: STUDY_DIRECTOR
References: