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Efficacy and Safety of rTMS for Cognitive Rehabilitation in Moyamoya Disease

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ClinicalTrials.gov Identifier: NCT03543748
Recruitment Status : Unknown
Verified April 2018 by Yu Lei, Huashan Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 1, 2018
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Yu Lei, Huashan Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Moyamoya Disease Device: Transcranial Magnetic Stimulation Device: Sham Transcranial Magnetic Stimulation Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of rTMS for Cognitive Rehabilitation in Moyamoya Disease
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
Experimental: TMS
The Transcranial Magnetic Stimulation course consisted of daily sessions of 2,000 stimuli for the left DLPFC (50 trains of 40 stimuli at 10 Hz for 10 days),
 Device: Transcranial Magnetic Stimulation
A total of 2000 trains will be delivered successively. The pulses will be delivered at 80% of motor thresholds.
Other Name: TMS
Sham Comparator: SHAM
The patient is treated with Sham-TMS stimulation according to protocol with an inactive coil. The sham coil looks and sounds just like the real coil, but produces a negligible magnetic field.
 Device: Sham Transcranial Magnetic Stimulation
The sham coil looks and sounds just like the real coil, but produces a negligible magnetic field.
Other Name: Sham-TMS


Outcome Measures
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Primary Outcome Measures :
  1. Neurocognitive outcomes at 3 months follow-up after TMS [ Time Frame: 3 months ]
    Measure neurocognitive outcomes using Mini-mental State Examination (MMSE)

  2. Neurocognitive outcomes at 3 months follow-up after TMS [ Time Frame: 3 months ]
    Measure neurocognitive outcomes using memory and executive screening (MES)


Secondary Outcome Measures :
  1. Change in structural imaging in the brain at baseline compared to after TMS stimulation [ Time Frame: 3 months ]
    MRI analysis will measure any changes in cortical thickness (mm) in the brain after TMS or Sham-TMS stimulation

  2. Change in structural imaging in the brain at baseline compared to after TMS stimulation [ Time Frame: 3 months ]
    MRI analysis will measure any changes in cortical white matter micro-structure (DTI) in the brain after TMS or Sham-TMS stimulation

  3. Change in functional imaging in the brain at baseline compaired to after TMS stimulation [ Time Frame: 3 month ]
    MRI analysis will measure any changes in ALFF in the brain after TMS or Sham-TMS stimulation

  4. Change in functional imaging in the brain at baseline compaired to after TMS stimulation [ Time Frame: 3 month ]
    MRI analysis will measure any changes in functional connectivity strength in the brain after TMS or Sham-TMS stimulation


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Yu Lei, attending doctor, Huashan Hospital
ClinicalTrials.gov Identifier: NCT03543748    
Other Study ID Numbers: Ylei
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: April 2018

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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
Keywords provided by Yu Lei, Huashan Hospital:
Transcranial Magnetic Stimulation
cognitive impairment
Additional relevant MeSH terms:
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Moyamoya Disease
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Cerebral Arterial Diseases
Intracranial Arterial Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases