Efficacy and Safety of rTMS for Cognitive Rehabilitation in Moyamoya Disease

Moyamoya Disease Clinical Trial

Official title:

Efficacy and Safety of rTMS for Cognitive Rehabilitation in Moyamoya Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03543748
• Other study ID #: Ylei
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: April 2018
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Moyamoya Disease

Intervention

Device:
• Transcranial Magnetic Stimulation
A total of 2000 trains will be delivered successively. The pulses will be delivered at 80% of motor thresholds.
• Sham Transcranial Magnetic Stimulation
The sham coil looks and sounds just like the real coil, but produces a negligible magnetic field.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurocognitive outcomes at 3 months follow-up after TMS	Measure neurocognitive outcomes using Mini-mental State Examination (MMSE)	3 months
Primary	Neurocognitive outcomes at 3 months follow-up after TMS	Measure neurocognitive outcomes using memory and executive screening (MES)	3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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