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

December 7, 2022 updated by: Hao Zhang, China Rehabilitation Research Center

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100071
        • China Rehabilitation Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: high dose TBS group
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
expect for the TBS, all patients get cognitive training alike on a training system in medical center.
Other Names:
  • Cognitive training
Experimental: low dose TBS group
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
expect for the TBS, all patients get cognitive training alike on a training system in medical center.
Other Names:
  • Cognitive training
Sham Comparator: high dose sham TBS group
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
expect for the TBS, all patients get cognitive training alike on a training system in medical center.
Other Names:
  • Cognitive training
Sham Comparator: low dose sham TBS group
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
expect for the TBS, all patients get cognitive training alike on a training system in medical center.
Other Names:
  • Cognitive training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Montreal Cognitive Assessment scale
Time Frame: 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.
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
Time Frame: 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.
1. finished in 3 days before TBS stimulation. 2. finished in 3 days after stimulation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Rehabilitation Research Center

Investigators

  • Study Director: Hao Zhang, China Rehabilitation Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 31, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

October 9, 2022

First Submitted That Met QC Criteria

October 12, 2022

First Posted (Actual)

October 13, 2022

Study Record Updates

Last Update Posted (Estimate)

December 8, 2022

Last Update Submitted That Met QC Criteria

December 7, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HZhang

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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