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Device
tDCS for Cerebral Atherosclerosis
N/A
Waitlist Available
Led By Zafer Keser
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Vasculopathy leading to imaging evidence of hypoperfusion
Cognitive impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up phase 2 days 0, 14±3, 44±7, and 58±14, 72±14
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to investigate if a type of brain stimulation called transcranial direct current stimulation (tDCS) can boost blood flow in the brain and potentially help with cognitive issues.
Who is the study for?
This trial is for individuals with conditions like Moyamoya Syndrome and various forms of cerebral atherosclerosis, which affect blood flow to the brain. Participants should be experiencing cognitive impairment due to these conditions.
What is being tested?
The study tests if using transcranial direct current stimulation (tDCS), specifically Soterix® devices, can boost blood flow in the brain and improve thinking skills affected by chronic hypoperfusion.
What are the potential side effects?
Potential side effects of tDCS may include mild tingling, itching or discomfort at the electrode site on the scalp, fatigue, headache, nausea or dizziness during or after treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My scans show reduced blood flow due to blood vessel issues.
Select...
I have trouble with memory or thinking clearly.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ phase 2 days 0, 14±3, 44±7, and 58±14, 72±14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~phase 2 days 0, 14±3, 44±7, and 58±14, 72±14
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in cerebral blood flow
Secondary study objectives
Change in Fatigue Severity Scale (FFS)
Change in Stroke Specific Quality of Life (SS-QOL)
Change in Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F)
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
6Treatment groups
Experimental Treatment
Group I: Phase II Sham Stimulation, Then Active StimulationExperimental Treatment2 Interventions
Subjects first receive sham tDCS plus cognitive training daily for 10 days. After a washout period of 4 weeks, they will perform at-home active tDCS plus cognitive training daily for 10 days.
Group II: Phase II Active Stimulation, Then Sham StimulationExperimental Treatment2 Interventions
Subjects first receive active tDCS plus cognitive training every weekday for 10 days. After washout period of 4 weeks, they will perform at-home sham tDCS plus cognitive training every weekday for 10 days.
Group III: Phase I Disease Group: Sham Stimulation, Then Active StimulationExperimental Treatment1 Intervention
Subject diagnosed with Moyamoya disease or severe extracranial atherosclerotic disease will receive sham stimulation concurrently with MRI CBF imaging immediately followed by no stimulation and CBF imaging. Next, subjects will receive 20 minutes of 2 mA tDCS concurrently with CBF imaging immediately followed by no stimulation and CBF imaging.
Group IV: Phase I Disease Group: Active Stimulation, Then Sham StimulationExperimental Treatment1 Intervention
Subject diagnosed with Moyamoya disease or severe extracranial atherosclerotic disease will receive 20 minutes of 2 mA tDCS concurrently with MRI cerebral blood flow (CBF) imaging immediately followed by no stimulation and CBF imaging. Next, subjects will receive sham stimulation concurrently with CBF imaging immediately followed by no stimulation and CBF imaging.
Group V: Phase I - Health Volunteer Group: Sham Stimulation, Then Active StimulationExperimental Treatment1 Intervention
Healthy subjects will receive sham stimulation concurrently with MRI CBF imaging immediately followed by no stimulation and CBF imaging. Next, subjects will receive 20 minutes of 2 mA tDCS concurrently with CBF imaging immediately followed by no stimulation and CBF imaging.
Group VI: Phase I - Health Volunteer Group: Active Stimulation, Then Sham StimulationExperimental Treatment1 Intervention
Healthy subjects will receive 20 minutes of 2 mA tDCS concurrently with MRI cerebral blood flow (CBF) imaging immediately followed by no stimulation and CBF imaging. Next, subjects will receive sham stimulation concurrently with CBF imaging immediately followed by no stimulation and CBF imaging.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive training program
2016
Completed Phase 4
~310
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,354 Previous Clinical Trials
3,061,118 Total Patients Enrolled
1 Trials studying Moyamoya Disease
5,000 Patients Enrolled for Moyamoya Disease
Zafer KeserPrincipal InvestigatorMayo Clinic