Efficacy and Safety of rTMS for Cognitive Rehabilitation in Moyamoya Disease

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.

Study Overview

• Status: Unknown
• Conditions: Moyamoya Disease
• Intervention / Treatment: Device: Transcranial Magnetic Stimulation; Device: Sham Transcranial Magnetic Stimulation

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Sham-TMS

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	3 month

Collaborators and Investigators

• Sponsor: Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2018
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: December 15, 2017
• First Submitted That Met QC Criteria: May 20, 2018
• First Posted (Actual): June 1, 2018

Study Record Updates

• Last Update Posted (Actual): June 1, 2018
• Last Update Submitted That Met QC Criteria: May 20, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Transcranial Magnetic Stimulation; cognitive impairment
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Moyamoya Disease
• Other Study ID Numbers: Ylei

Drug and device information, study documents

• 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