A Study of Cerebral Perfusion With tDCS in Chronic Hypoperfusion

NCT06477107 | Enrolling By Invitation FDA Device

• 1 other identifier: 24-001186
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Moyamoya Syndrome; Moyamoya Disease; Atheroscleroses, Cerebral

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in cognitive impairment

  Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14

• Change in Fatigue Severity Scale (FFS)

  Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14

• Change in Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F)

  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)

  Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14

• Change in depression severity

  Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14

Study Arms (6)

Phase I - Health Volunteer Group: Active Stimulation, Then Sham Stimulation

EXPERIMENTAL

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

Phase I - Health Volunteer Group: Sham Stimulation, Then Active Stimulation

EXPERIMENTAL

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

Phase I Disease Group: Active Stimulation, Then Sham Stimulation

EXPERIMENTAL

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

Phase I Disease Group: Sham Stimulation, Then Active Stimulation

EXPERIMENTAL

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

Phase II Active Stimulation, Then Sham Stimulation

EXPERIMENTAL

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; Behavioral: Cognitive training program

Phase II Sham Stimulation, Then Active Stimulation

EXPERIMENTAL

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; Behavioral: Cognitive training program

Interventions

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.

Phase II Active Stimulation, Then Sham Stimulation; Phase II Sham Stimulation, Then Active Stimulation

Cognitive training program BEHAVIORAL

Computerized cognitive therapy for 45 minutes per day that starts at the same time with stimulation

Phase II Active Stimulation, Then Sham Stimulation; Phase II Sham Stimulation, Then Active Stimulation

Soterix® 4x1HD-TDCS DEVICE

Is intended for inducing cortical neuromodulation for research and treatment purposes.

Phase I - Health Volunteer Group: Active Stimulation, Then Sham Stimulation; Phase I - Health Volunteer Group: Sham Stimulation, Then Active Stimulation; Phase I Disease Group: Active Stimulation, Then Sham Stimulation; Phase I Disease Group: Sham Stimulation, Then Active Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Vasculopathy leading to imaging evidence of hypoperfusion
• Cognitive impairment

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Moyamoya Disease; Intracranial Arteriosclerosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis

Study Officials

• Zafer Keser

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: For the Phase I portion of the study subjects the order of the stimulation (active vs sham stimulation) in a single session will be randomized and counterbalanced across subjects. For the Phase II portion of the study a cross-over design will be used and the subjects will be randomly assigned either to active or sham tDCS first, then they will cross over to the other treatment arm after 4-week period of washout.

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 27, 2024
• Study Start: October 24, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)