Moyamoya SyndromeNCT06477107
A Study of Cerebral Perfusion With tDCS in Chronic Hypoperfusion
A study testing Soterix® 4x1HD-TDCS, Soterix® 1x1 tDCS and Cognitive training program in people with Moyamoya Syndrome and Moyamoya Disease, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moyamoya Syndrome, Moyamoya Disease, Atheroscleroses, Cerebral
- What is being tested?
- Soterix® 4x1HD-TDCS, Soterix® 1x1 tDCS and Cognitive training program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2024to 13 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Vasculopathy leading to imaging evidence of hypoperfusion
- Cognitive impairment
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
- Being tested
- Soterix® 4x1HD-TDCS, Soterix® 1x1 tDCS, Cognitive training program
- Medical subject headings
- Moyamoya Disease, Intracranial Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soterix® 4x1HD-TDCSDevice
Is intended for inducing cortical neuromodulation for research and treatment purposes.
Soterix® 1x1 tDCSDevice
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 programBehavioural
Computerized cognitive therapy for 45 minutes per day that starts at the same time with stimulation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Soterix® 1x1 tDCS; Behavioral: Cognitive training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Phase 1 Day 0 and Phase 2 Day 0, 14, 44, and 58
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start24 Oct 2024
- Primary completion13 May 2026
- Study completion13 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moyamoya SyndromeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zafer Keser, Mayo Clinic
- Investigators
- Zafer Keser, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477107
- Sponsor's protocol ID
- 24-001186
- Status last verified
- Aug 2026
- First submitted
- 6 Jun 2024
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting Cerebral Perfusion With Transcranial Direct Current Stimulation (tDCS) in Chronic Hypoperfusion States
- ClinicalTrials.gov ID
- NCT06477107
- Acronym / sponsor ID
- 24-001186
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 13 May 2026 (actual)
- Study completion
- 13 May 2026 (actual)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Phase I - Health Volunteer Group: Active Stimulation, Then Sham Stimulation | Experimental | Device: Soterix® 4x1HD-TDCSHealthy 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. |
| Phase I - Health Volunteer Group: Sham Stimulation, Then Active Stimulation | Experimental | Device: Soterix® 4x1HD-TDCSHealthy 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. |
| Phase I Disease Group: Active Stimulation, Then Sham Stimulation | Experimental | Device: Soterix® 4x1HD-TDCSSubject 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. |
| Phase I Disease Group: Sham Stimulation, Then Active Stimulation | Experimental | Device: Soterix® 4x1HD-TDCSSubject 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. |
| Phase II Active Stimulation, Then Sham Stimulation | Experimental | Device: Soterix® 1x1 tDCS, Behavioral: Cognitive training programSubjects 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. |
| Phase II Sham Stimulation, Then Active Stimulation | Experimental | Device: Soterix® 1x1 tDCS, Behavioral: Cognitive training programSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Vasculopathy leading to imaging evidence of hypoperfusion
- Cognitive impairment
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soterix® 4x1HD-TDCSIs intended for inducing cortical neuromodulation for research and treatment purposes. | Device | 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 |
| Soterix® 1x1 tDCSAt-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. | Device | Phase II Active Stimulation, Then Sham Stimulation, Phase II Sham Stimulation, Then Active Stimulation |
| Cognitive training programComputerized cognitive therapy for 45 minutes per day that starts at the same time with stimulation | Behavioural | Phase II Active Stimulation, Then Sham Stimulation, Phase II Sham Stimulation, Then Active Stimulation |
Primary outcome
Changes in cerebral blood flow
Time frame: Phase 1 Day 0 and Phase 2 Day 0, 14, 44, and 58
Cerebral blood flow imaging assessed by MRI to measure blood flow through the blood vessels reported in millimeters of mercury (mmHg)
8 secondary outcomes
Change in cognitive impairment
Time frame: Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14
Change in Fatigue Severity Scale (FFS)
Time frame: Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14
Change in Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F)
Time frame: 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)
Time frame: Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14
Change in depression severity
Time frame: Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14
Change in sleepiness
Time frame: Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14
Change in trail making test
Time frame: Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14
Change in memory task
Time frame: Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zafer Keser principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soterix® 4x1HD-TDCS, Soterix® 1x1 tDCS and Cognitive training program in people with Moyamoya Syndrome and Moyamoya Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cerebral blood flow (time frame: Phase 1 Day 0 and Phase 2 Day 0, 14, 44, and 58). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.