Clinical trial NCT03543748: Efficacy and Safety of rTMS for Cognitive Rehabilitation in Moyamoya Disease
Official title: Efficacy and Safety of rTMS for Cognitive Rehabilitation in Moyamoya Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Moyamoya Disease
Keywords: Transcranial Magnetic Stimulation
cognitive impairment
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Neurocognitive outcomes at 3 months follow-up after TMS
timeFrame: 3 months
measure: Neurocognitive outcomes at 3 months follow-up after TMS
timeFrame: 3 months
Secondary outcomes:
measure: Change in structural imaging in the brain at baseline compared to after TMS stimulation
timeFrame: 3 months
measure: Change in structural imaging in the brain at baseline compared to after TMS stimulation
timeFrame: 3 months
measure: Change in functional imaging in the brain at baseline compaired to after TMS stimulation
timeFrame: 3 month
measure: Change in functional imaging in the brain at baseline compaired to after TMS stimulation
timeFrame: 3 month
Other outcomes:
Locations:
Study officials:
References: