Trials / Unknown
UnknownNCT03543748
Efficacy and Safety of rTMS for Cognitive Rehabilitation in Moyamoya Disease
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Huashan Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Transcranial Magnetic Stimulation | A total of 2000 trains will be delivered successively. The pulses will be delivered at 80% of motor thresholds. |
| DEVICE | Sham Transcranial Magnetic Stimulation | The sham coil looks and sounds just like the real coil, but produces a negligible magnetic field. |
Timeline
- Start date
- 2018-08-01
- Primary completion
- 2019-01-01
- Completion
- 2019-03-01
- First posted
- 2018-06-01
- Last updated
- 2018-06-01
Source: ClinicalTrials.gov record NCT03543748. Inclusion in this directory is not an endorsement.