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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and phase 2 days 0, 14±3, 44±7, and 58±14, 72±14 for reporting.

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 more

Awards & 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

0 / 2Eligibility criteria met