A Study of Cerebral Perfusion With tDCS in Chronic Hypoperfusion

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06477107
Status
Enrolling By Invitation

Conditions

  • Atheroscleroses, Cerebral
  • Moyamoya Disease
  • Moyamoya Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Soterix® 4x1HD-TDCS — DEVICE
    Is intended for inducing cortical neuromodulation for research and treatment purposes.
  • Soterix® 1x1 tDCS — DEVICE
    At-home remotely supervised transcranial direct current stimulation (tDCS) at an intensity of 2 mA for 20 minutes per session, with slow ramp-up and automatic turn off once it reaches the maximal intensity.
  • Cognitive training program — BEHAVIORAL
    Computerized cognitive therapy for 45 minutes per day that starts at the same time with stimulation

Study Details

This study is being done to examine whether transcranial direct current stimulation (tDCS) will increase cerebral blood flow which may provide a clinical benefit such as improving cognitive impairment.

Key Dates

Start date
Oct 24, 2024
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Phase I - Health Volunteer Group: Active Stimulation, Then Sham Stimulation
    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.
  • Experimental: Phase I - Health Volunteer Group: Sham Stimulation, Then Active Stimulation
    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.
  • Experimental: Phase I Disease Group: Active Stimulation, Then Sham Stimulation
    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.
  • Experimental: Phase I Disease Group: Sham Stimulation, Then Active Stimulation
    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.
  • Experimental: Phase II Active Stimulation, Then Sham Stimulation
    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.
  • Experimental: Phase II Sham Stimulation, Then Active Stimulation
    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.

Primary Outcome Measure

Changes in cerebral blood flow [ Time Frame: Phase 1 Day 0 and Phase 2 Day 0, 14, 44, and 58 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905-

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By research site
Mayo Clinic in Rochester· Rochester, MN

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