A Study of Cerebral Perfusion with TDCS in Chronic Hypoperfusion
- Conditions
- Atheroscleroses, CerebralMoyamoya SyndromeMoyamoya Disease
- Interventions
- Device: Soterix® 4x1HD-TDCSDevice: Soterix® 1x1 tDCSBehavioral: Cognitive training program
- Registration Number
- NCT06477107
- Lead Sponsor
- Mayo Clinic
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 50
- Vasculopathy leading to imaging evidence of hypoperfusion
- Cognitive impairment
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Phase I - Health Volunteer Group: Active Stimulation, Then Sham Stimulation Soterix® 4x1HD-TDCS 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. Phase I Disease Group: Sham Stimulation, Then Active Stimulation Soterix® 4x1HD-TDCS 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. Phase II Active Stimulation, Then Sham Stimulation Soterix® 1x1 tDCS 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. Phase II Sham Stimulation, Then Active Stimulation Cognitive training program 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. Phase I Disease Group: Active Stimulation, Then Sham Stimulation Soterix® 4x1HD-TDCS 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. Phase I - Health Volunteer Group: Sham Stimulation, Then Active Stimulation Soterix® 4x1HD-TDCS 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. Phase II Active Stimulation, Then Sham Stimulation Cognitive training program 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. Phase II Sham Stimulation, Then Active Stimulation Soterix® 1x1 tDCS 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 Measures
Name Time Method Changes in cerebral blood flow 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)
- Secondary Outcome Measures
Name Time Method Change in trail making test Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14 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.
Change in memory task Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14 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.
Change in cognitive impairment Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14 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.
Change in Stroke Specific Quality of Life (SS-QOL) Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14 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.
Change in depression severity Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14 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.
Change in sleepiness Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14 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.
Change in Fatigue Severity Scale (FFS) Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14 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.
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 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.
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States