Moyamoya DiseaseNCT03543748
Efficacy and Safety of rTMS for Cognitive Rehabilitation in Moyamoya Disease
A study testing Transcranial Magnetic Stimulation in people with Moyamoya Disease, run by Huashan Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Moyamoya Disease
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2018to 1 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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.
Read the 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
- Moyamoya Disease
- Being tested
- Transcranial Magnetic Stimulation, Sham Transcranial Magnetic Stimulation
- Keywords
- Transcranial Magnetic Stimulation, cognitive impairment
- Medical subject headings
- Moyamoya Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
Also called TMS
A total of 2000 trains will be delivered successively. The pulses will be delivered at 80% of motor thresholds.
Sham Transcranial Magnetic StimulationDevice
Also called Sham-TMS
The sham coil looks and sounds just like the real coil, but produces a negligible magnetic field.
| Study group | Role | What they receive |
|---|---|---|
| TMS | Experimental | 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), Receives: Device: Transcranial Magnetic Stimulation |
| SHAM | Sham comparator | 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. Receives: Device: Sham Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive outcomes at 3 months follow-up after TMS
Measure neurocognitive outcomes using Mini-mental State Examination (MMSE)
Measured: 3 months
Neurocognitive outcomes at 3 months follow-up after TMS
Measure neurocognitive outcomes using memory and executive screening (MES)
Measured: 3 months
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start1 Aug 2018 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moyamoya DiseaseStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Lei, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543748
- Sponsor's protocol ID
- Ylei
- Status last verified
- Apr 2018
- First submitted
- 15 Dec 2017
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of rTMS for Cognitive Rehabilitation in Moyamoya Disease
- ClinicalTrials.gov ID
- NCT03543748
- Acronym / sponsor ID
- Ylei
- Conditions
- Moyamoya Disease
- Keywords
- Transcranial Magnetic Stimulation, cognitive impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 1 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMS | Experimental | Device: Transcranial Magnetic StimulationThe 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), |
| SHAM | Sham comparator | Device: Sham Transcranial Magnetic StimulationThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic StimulationAlso: TMSA total of 2000 trains will be delivered successively. The pulses will be delivered at 80% of motor thresholds. | Device | TMS |
| Sham Transcranial Magnetic StimulationAlso: Sham-TMSThe sham coil looks and sounds just like the real coil, but produces a negligible magnetic field. | Device | SHAM |
Primary outcome
Neurocognitive outcomes at 3 months follow-up after TMS
Time frame: 3 months
Measure neurocognitive outcomes using Mini-mental State Examination (MMSE)
Neurocognitive outcomes at 3 months follow-up after TMS
Time frame: 3 months
Measure neurocognitive outcomes using memory and executive screening (MES)
4 secondary outcomes
Change in structural imaging in the brain at baseline compared to after TMS stimulation
Time frame: 3 months
Change in structural imaging in the brain at baseline compared to after TMS stimulation
Time frame: 3 months
Change in functional imaging in the brain at baseline compaired to after TMS stimulation
Time frame: 3 month
Change in functional imaging in the brain at baseline compaired to after TMS stimulation
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation in people with Moyamoya Disease, run by Huashan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognitive outcomes at 3 months follow-up after TMS (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2018.