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
About this trial
This is an interventional treatment trial for Moyamoya Disease focused on measuring Transcranial Magnetic Stimulation, cognitive impairment
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
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
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
Learn more about this trial
Efficacy and Safety of rTMS for Cognitive Rehabilitation in Moyamoya Disease
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