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Efficacy and Safety of rTMS for Cognitive Rehabilitation in Moyamoya Disease

Primary Purpose

Moyamoya Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Sham Transcranial Magnetic Stimulation
Sponsored by
Huashan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moyamoya Disease focused on measuring Transcranial Magnetic Stimulation, cognitive impairment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    TMS

    SHAM

    Arm Description

    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),

    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.

    Outcomes

    Primary Outcome Measures

    Neurocognitive outcomes at 3 months follow-up after TMS
    Measure neurocognitive outcomes using Mini-mental State Examination (MMSE)
    Neurocognitive outcomes at 3 months follow-up after TMS
    Measure neurocognitive outcomes using memory and executive screening (MES)

    Secondary Outcome Measures

    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
    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
    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
    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

    Full Information

    First Posted
    December 15, 2017
    Last Updated
    May 20, 2018
    Sponsor
    Huashan Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03543748
    Brief Title
    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

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2018 (Anticipated)
    Primary Completion Date
    January 1, 2019 (Anticipated)
    Study Completion Date
    March 1, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Huashan Hospital

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Moyamoya Disease
    Keywords
    Transcranial Magnetic Stimulation, cognitive impairment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TMS
    Arm Type
    Experimental
    Arm Description
    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),
    Arm Title
    SHAM
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Transcranial Magnetic Stimulation
    Other Intervention Name(s)
    TMS
    Intervention Description
    A total of 2000 trains will be delivered successively. The pulses will be delivered at 80% of motor thresholds.
    Intervention Type
    Device
    Intervention Name(s)
    Sham Transcranial Magnetic Stimulation
    Other Intervention Name(s)
    Sham-TMS
    Intervention Description
    The sham coil looks and sounds just like the real coil, but produces a negligible magnetic field.
    Primary Outcome Measure Information:
    Title
    Neurocognitive outcomes at 3 months follow-up after TMS
    Description
    Measure neurocognitive outcomes using Mini-mental State Examination (MMSE)
    Time Frame
    3 months
    Title
    Neurocognitive outcomes at 3 months follow-up after TMS
    Description
    Measure neurocognitive outcomes using memory and executive screening (MES)
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Change in structural imaging in the brain at baseline compared to after TMS stimulation
    Description
    MRI analysis will measure any changes in cortical thickness (mm) in the brain after TMS or Sham-TMS stimulation
    Time Frame
    3 months
    Title
    Change in structural imaging in the brain at baseline compared to after TMS stimulation
    Description
    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
    Title
    Change in functional imaging in the brain at baseline compaired to after TMS stimulation
    Description
    MRI analysis will measure any changes in ALFF in the brain after TMS or Sham-TMS stimulation
    Time Frame
    3 month
    Title
    Change in functional imaging in the brain at baseline compaired to after TMS stimulation
    Description
    MRI analysis will measure any changes in functional connectivity strength in the brain after TMS or Sham-TMS stimulation
    Time Frame
    3 month

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: right-handed Chinese population aged 18-80 years; 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; No evidence of intracerebral hemorrhage; diagnosis through digital subtraction angiography; physically capable of cognitive evaluation; absence of significant psychiatric disorders or neurological diseases; No evidence of perioperative epilepsy. Exclusion Criteria: Significant neurological diseases or psychiatric disorders that could affect cognition Other cerebrovascular diseases (such as atherosclerosis or vasculitides) likely to cause focal cerebral ischemia Concomitant cerebrovascular diseases (such as aneurysms or arteriovenous malformation) that need surgical intervention Severe systemic diseases pregnant or perinatal stage women Any diseases likely to death within 2 years Taking drugs such as benzodiazepine clonazepam Allergy to iodine or radiographic contrast media Concurrent participation in any other experimental treatment trial

    12. IPD Sharing Statement

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    Efficacy and Safety of rTMS for Cognitive Rehabilitation in Moyamoya Disease

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