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

NCT05578183 | Withdrawn

• 1 other identifier: HZhang
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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. 1.To explore the therapeutic effect of TBS to patients with PSCI.
2. 2.To compare effect of TBS with different dose.
3. 3.To explore the mechanism of TBS by functional magnetic resonance imaging (fMRI).
4. 4.Treated with TBS and cognitive training for 3 weeks (15 days).
5. 5.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.
6. 6.Perform the resting fMRI, electroencephalogram (EEG) and event related potential before and after treatment.

Conditions

Stroke; Stroke Sequelae; Cognitive Impairment

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from Baseline Mini-mental State Examination scale

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

Study Arms (4)

high dose TBS group

EXPERIMENTAL

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

low dose TBS group

EXPERIMENTAL

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

high dose sham TBS group

SHAM COMPARATOR

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

low dose sham TBS group

SHAM COMPARATOR

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

Interventions

theta burst stimulation DEVICE

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

Also known as: Cognitive training

high dose TBS group; low dose TBS group

sham stimulation DEVICE

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

Also known as: Cognitive training

high dose sham TBS group; low dose sham TBS group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Rehabilitation Research Center: lead

Study Sites (1)

China rehabilitation research center

Beijing, Beijing Municipality, 100071, China

Location

MeSH Terms

Conditions

Stroke; Cognitive Dysfunction

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Hao Zhang

  China Rehabilitation Research Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 9, 2022
• First Posted: October 13, 2022
• Study Start: December 31, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 8, 2022

Record last verified: 2022-12

Locations

CN (1)