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

Primary Purpose

Stroke, Stroke Sequelae, Cognitive Impairment

Status

Withdrawn

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

theta burst stimulation

sham stimulation

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, cognitive impairment, transcranial magnetic stimulation, Functional Magnetic Resonance Imaging, event related potential

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

China rehabilitation research center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Arm Label

high dose TBS group

low dose TBS group

high dose sham TBS group

low dose sham TBS group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05578183

First Posted

October 9, 2022

Last Updated

December 7, 2022

Sponsor

China Rehabilitation Research Center

1. Study Identification

Unique Protocol Identification Number

NCT05578183

Brief Title

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

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Withdrawn

Why Stopped

The study has been registed in ChiCTR and apply for withdrawing.

Study Start Date

December 31, 2022 (Anticipated)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

China Rehabilitation Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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: To explore the therapeutic effect of TBS to patients with PSCI. To compare effect of TBS with different dose. To explore the mechanism of TBS by functional magnetic resonance imaging (fMRI). Participants will be asked to do: Treated with TBS and cognitive training for 3 weeks (15 days). 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. 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 Patients were recruited and agreed with Informed Consent. 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). TBS was performed for 15 days (5 days * 3 weeks). Within 3 days after TBS, all patients were assessed with MMSE, MoCA, LOTCA, WAIS and WMS, meanwhile they conduct fMRI and EEG. Data acquisition and analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Stroke Sequelae, Cognitive Impairment

Keywords

stroke, cognitive impairment, transcranial magnetic stimulation, Functional Magnetic Resonance Imaging, event related potential

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

high dose TBS group

Arm Type

Experimental

Arm Description

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

Arm Title

low dose TBS group

Arm Type

Experimental

Arm Description

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

Arm Title

high dose sham TBS group

Arm Type

Sham Comparator

Arm Description

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

Arm Title

low dose sham TBS group

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

theta burst stimulation

Other Intervention Name(s)

Cognitive training

Intervention Description

expect for the TBS, all patients get cognitive training alike on a training system in medical center.

Intervention Type

Device

Intervention Name(s)

sham stimulation

Other Intervention Name(s)

Cognitive training

Intervention Description

expect for the TBS, all patients get cognitive training alike on a training system in medical center.

Primary Outcome Measure Information:

Title

Change from Baseline Montreal Cognitive Assessment scale

Description

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.

Time Frame

1. finished in 3 days before TBS stimulation. 2. finished in 3 days after stimulation.

Secondary Outcome Measure Information:

Title

Change from Baseline Mini-mental State Examination scale

Description

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.

Time Frame

1. finished in 3 days before TBS stimulation. 2. finished in 3 days after stimulation.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hao Zhang

Organizational Affiliation

China Rehabilitation Research Center

Official's Role

Study Director

Facility Information:

Facility Name

China rehabilitation research center

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100071

Country

China

12. IPD Sharing Statement

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

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