Efficacy and Safety of rTMS for Cognitive Rehabilitation in Moyamoya Disease

Huashan Hospital50 enrolled

Overview

The purpose of this study is to evaluate the safety and effectiveness of transcranial magnetic stimulation (TMS) therapy in moyamoya patients who received surgical revascularization.

Primary Outcome Measures: TMS stimulation applied to the left DLPFC has a quantifiable effect on cognition \[ Time Frame: Neuropsychological Assessments: Baseline（7days after STA-MCA bypass surgery）; 2 months after TMS treatment Changes in one or more assessed cognitive domains at baseline will be measured by comparing the scores for the different neuropsychological tests. Secondary Outcome Measures: Change in structural grey and white matter in the brain at baseline compared to after TMS stimulation \[ Time Frame: MRI: Baseline and two months after TMS stimulation \] MRI analysis will measure any changes in cortical thickness (mm) or other structural changes in the brain after TMS or Sham-TMS stimulation Change in executive functioning measured as resting-state functional MRI (fMRI) sequence \[ Time Frame: MRI: Baseline and two months after TMS stimulation \] fMRI analysis will measure any changes in amplitude of low frequency fluctuation(ALFF) and other functional changes after TMS stimulation compared to baseline.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Moyamoya Disease

Interventions

Transcranial Magnetic StimulationDEVICE

A total of 2000 trains will be delivered successively. The pulses will be delivered at 80% of motor thresholds.

Sham Transcranial Magnetic StimulationDEVICE

The sham coil looks and sounds just like the real coil, but produces a negligible magnetic field.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. right-handed Chinese population aged 18-80 years; 2. No evidence of infarct in the cerebral cortex, basal ganglia, brainstem, or cerebellum, but small patches of hyper intense signal neither larger than the arbitrary cut off of 8 mm in maximum dimension on T2-weighted MR images no cystic in the cerebral subcortical white matter could be involved; 3. No evidence of intracerebral hemorrhage; 4. diagnosis through digital subtraction angiography; 5. physically capable of cognitive evaluation; 6. absence of significant psychiatric disorders or neurological diseases; 7. No evidence of perioperative epilepsy. Exclusion Criteria: 1. Significant neurological diseases or psychiatric disorders that could affect cognition 2. Other cerebrovascular diseases (such as atherosclerosis or vasculitides) likely to cause focal cerebral ischemia 3. Concomitant cerebrovascular diseases (such as aneurysms or arteriovenous malformation) that need surgical intervention 4. Severe systemic diseases pregnant or perinatal stage women 5. Any diseases likely to death within 2 years 6. Taking drugs such as benzodiazepine clonazepam 7. Allergy to iodine or radiographic contrast media 8. Concurrent participation in any other experimental treatment trial

Outcomes

Primary Outcomes

Neurocognitive outcomes at 3 months follow-up after TMS

Measure neurocognitive outcomes using Mini-mental State Examination (MMSE)

Time frame: 3 months

Neurocognitive outcomes at 3 months follow-up after TMS

Measure neurocognitive outcomes using memory and executive screening (MES)

Time frame: 3 months

Secondary Outcomes

Change in structural imaging in the brain at baseline compared to after TMS stimulation

MRI analysis will measure any changes in cortical thickness (mm) in the brain after TMS or Sham-TMS stimulation

Time frame: 3 months

Change in structural imaging in the brain at baseline compared to after TMS stimulation

MRI analysis will measure any changes in cortical white matter micro-structure (DTI) in the brain after TMS or Sham-TMS stimulation

Time frame: 3 months

Change in functional imaging in the brain at baseline compaired to after TMS stimulation

MRI analysis will measure any changes in ALFF in the brain after TMS or Sham-TMS stimulation

Time frame: 3 month

Change in functional imaging in the brain at baseline compaired to after TMS stimulation

MRI analysis will measure any changes in functional connectivity strength in the brain after TMS or Sham-TMS stimulation

Time frame: 3 month

Data from ClinicalTrials.gov

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