NCT03543748

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 1, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

June 1, 2018

Status Verified

April 1, 2018

Enrollment Period

5 months

First QC Date

December 15, 2017

Last Update Submit

May 20, 2018

Conditions

Moyamoya Disease

Keywords

Transcranial Magnetic Stimulationcognitive impairment

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Change in structural imaging in the brain at baseline compared to after TMS stimulation

    3 months

  • Change in structural imaging in the brain at baseline compared to after TMS stimulation

    3 months

  • Change in functional imaging in the brain at baseline compaired to after TMS stimulation

    3 month

  • Change in functional imaging in the brain at baseline compaired to after TMS stimulation

    3 month

Study Arms (2)

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),

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.

Device: Sham Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic StimulationDEVICE

A total of 2000 trains will be delivered successively. The pulses will be delivered at 80% of motor thresholds.

Also known as: TMS
TMS
Sham Transcranial Magnetic StimulationDEVICE

The sham coil looks and sounds just like the real coil, but produces a negligible magnetic field.

Also known as: Sham-TMS
SHAM

Eligibility Criteria

Age18 Years - 80 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Moyamoya DiseaseCognitive Dysfunction

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebral Arterial DiseasesIntracranial Arterial DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
attending doctor

Study Record Dates

First Submitted

December 15, 2017

First Posted

June 1, 2018

Study Start

August 1, 2018

Primary Completion

January 1, 2019

Study Completion

March 1, 2019

Last Updated

June 1, 2018

Record last verified: 2018-04