A Study of Cerebral Perfusion With tDCS in Chronic Hypoperfusion

Augmenting Cerebral Perfusion With Transcranial Direct Current Stimulation (tDCS) in Chronic Hypoperfusion States

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Moyamoya Disease; Atheroscleroses, Cerebral; Moyamoya Syndrome
• Intervention / Treatment: Device: Soterix® 4x1HD-TDCS; Device: Soterix® 1x1 tDCS; Behavioral: Cognitive training program

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Vasculopathy leading to imaging evidence of hypoperfusion
• Cognitive impairment

Exclusion Criteria:

• Pregnancy
• Contraindication to MRI or tDCS including metallic implanted objects.
• Medical instability or inability to cooperate during the study as assessed by the treating physician to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Soterix® 4x1HD-TDCS; Is intended for inducing cortical neuromodulation for research and treatment purposes.
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.	Device: Soterix® 4x1HD-TDCS; Is intended for inducing cortical neuromodulation for research and treatment purposes.
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.	Device: Soterix® 4x1HD-TDCS; Is intended for inducing cortical neuromodulation for research and treatment purposes.
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.	Device: Soterix® 4x1HD-TDCS; Is intended for inducing cortical neuromodulation for research and treatment purposes.
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.	Device: Soterix® 1x1 tDCS; 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.; Behavioral: Cognitive training program; Computerized cognitive therapy for 45 minutes per day that starts at the same time with stimulation
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.	Device: Soterix® 1x1 tDCS; 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.; Behavioral: Cognitive training program; Computerized cognitive therapy for 45 minutes per day that starts at the same time with stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cerebral blood flow	Cerebral blood flow imaging assessed by MRI to measure blood flow through the blood vessels reported in millimeters of mercury (mmHg)	Phase 1 Day 0 and Phase 2 Day 0, 14, 44, and 58

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cognitive impairment	Assessed using the Montreal Cognitive Assessment (MoCA), which is a 30-item questionnaire that includes tests of orientation, attention, memory, language and visual-spatial skills. Possible total scores range from 0 to 30, with higher scores indicating higher cognitive function. A final total score of 26 and above is consider normal.	Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14
Change in Fatigue Severity Scale (FFS)	Assessed using the Fatigue Severity Scale (FFS) 9-item questionnaire that contains statements that rate fatigue symptoms on a scale of 1 to 7 where a low value (e.g., 1) indicates strong disagreement with the statement and a high value (e.g., 7) indicates strong agreement. Possible total scores range from 9 to 63, with higher scores indicating greater fatigue severity.	Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14
Change in Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F)	Assessed using the Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F) 18-item questionnaire that rates how a subject is currently feeling in regards to fatigue symptoms on a scale of 0 to 10 where a low value (e.g., 0) indicates "not at all/no effort at all" and a high value (e.g., 10) indicates "extremely/tremendous chore". Possible total scores range from 0 to 180, with higher scores indicating greater fatigue severity.	Phase I Day 0, Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14
Change in Stroke Specific Quality of Life (SS-QOL)	Assessed using the Stroke Specific Quality of Life (SS-QOL) 49-item questionnaire assessing quality of life with regards to energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity function, vision, and work/productivity on a scale of 1 to 5 where a low value (e.g., 1) indicates "total help/couldn't do it at all/strongly agree" and a high value (e.g., 5) indicates "no help needed/no trouble at all/strongly disagree". Possible total scores range from 49 to 245, with higher scores indicating better quality of life.	Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14
Change in depression severity	Assessed using the Patient Health Questionnaire 9-item (PHQ-9) scale to assess severity of depression. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score for the nine items ranges from 0 to 27 where 0 is no depression, 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, and 15-19 is moderately severe depression and 20-27 severe depression.	Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14
Change in sleepiness	Assessed using the Epworth sleepiness scale (ESS) 8-item questionnaire that measures daytime sleepiness in participants. Possible scores range from 0-24, with higher scores indicating a higher average sleep propensity in daily life, and a worse outcome.	Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14
Change in trail making test	The Trail Making Test is a two part assessment of cognitive functions, principally attention and working memory. Subjects connect a set of 25 dots as quickly as possible, connect 13 dots labeled alphabetically, and 12 dots that are numbered in an alternating pattern as quickly as possible without lifting the pen. Results are reported as the number of seconds required to complete the task with higher scores indicating greater impairment.	Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14
Change in memory task	Assessed using the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) wordlist memory test (WLT). This is a memory task for assessing word list recall. A list of 10 words are read 3 times and subjects are asked to recall the list of words. The more words recalled indicates less cognitive impairment.	Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Zafer Keser, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Intracranial Arterial Diseases; Carotid Artery Diseases; Cerebral Arterial Diseases; Moyamoya Disease; Intracranial Arteriosclerosis
• Other Study ID Numbers: 24-001186

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No