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

Last updated: December 7, 2022
Sponsor: China Rehabilitation Research Center
Overall Status: Trial Not Available

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Dementia

Treatment

N/A

Clinical Study ID

NCT05578183
HZhang
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • First-time stroke patients, meeting the diagnostic criteria set by the Fourth NationalConference 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 delayedmemory defects.
  • Patients or their family members sign the informed consent form.

Exclusion

Exclusion Criteria:

  • Contraindications or high risks for TBS, such as epilepsy, intracranial metalimplants, 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 otherreasons, such as visual and auditory disturbance, aphasia, agnosia, apraxia.

Study Design

Study Start date:
December 31, 2022
Estimated Completion Date:
December 31, 2023

Study 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.

Connect with a study center

  • China rehabilitation research center

    Beijing, Beijing 100071
    China

    Site Not Available

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