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| ID | Type | Description | Link |
|---|---|---|---|
| A535100 | Other Identifier | UW Madison | |
| Protocol Version 4/10/2026 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| Tiny Blue Dot Foundation | OTHER |
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The goal of this clinical trial is to learn whether brain stimulation technology can help people reach a meditative state quickly and easily without years of meditation training. The researchers want to see if this will help people distance themselves from their thoughts and feeling, and if this will lead to improvements in openness and wellbeing the same way meditation can.
Participants will:
This study is being done to evaluate the relative effectiveness of distinct types of non-invasive brain stimulation - NIBS (TES-TI and TES) on subjective ego disengagement and cortical activity in experienced meditators and meditation naïve healthy adults.
Stage 1a was designed to establish the optimal level of stimulation to achieve ego displacement in experienced meditators. Stage 1b used the level of stimulation established in 1a to discern the region of the posteromedial cortex (PMC) where disruption is most effective in achieving ego displacement in experienced meditators. This stage, stage 2 will use the most effective stimulation and PMC parameters to meditation naïve healthy adults.
Primary Objective (stage 2):
- To evaluate the effectiveness of NIBS on ego disengagement and cortical activity in meditation naïve healthy adults acutely and longitudinally
Secondary Objectives (stage 2):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stimulation | Experimental | Participants will undergo TES or TES-TI stimulation in 5-minute blocks up to eight times a day on three separate days each separated by one week. |
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| Sham stimulation | Sham Comparator | Participants will undergo sham stimulation in 5-minute blocks up to eight times a day on three separate days each separated by one week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial electrical stimulation (TES) | Device | TES uses specific electrode arrangement patterns to selectively stimulate the brain. Participants will wear an hdEEG (high density electroencephalography) cap which will allow intermittent periods of stimulation from TES. |
| Measure | Description | Time Frame |
|---|---|---|
| Ego-Disengagement scale | Ego-disengagement will be measured using the bell task. This meditation task consists of five "bell trials." During each trial, subjects will be asked to focus on the sound of a bell until it fades, then on the space left empty by the faded sound, resting free from thoughts as long as possible (meditation condition). Afterward, subjects will respond to a few questions designed to assess their level of ego-disengagement during the trials. This is a five-question form that asks subjects to rate, on a scale from 0-4, the degree to which they were perceiving something, imagining something, thinking about themselves, or thinking about something during the previous bell trial and then to rate the valence of their emotional state during the trial from 1 (highly negative) to 6 (highly positive). | baseline, week 1, week 2, week 3, week 7 |
| Cortical activity - change in gamma band power | Gamma band power will be measured with hdEEG during stimulation. A decrease indicates greater level of ego disengagement. | week 1, week 2, week 3, final visit (week 7) |
| Cortical activity - change in alpha band power | Alpha band power will be measured with hdEEG during stimulation. An increase indicates greater level of ego disengagement. | week 1, week 2, week 3, final visit (week 7) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Big Five Aspects Scale (BFAS) | This is a 44-item inventory that measures five different personality traits by asking subjects to respond to various items (e.g., I see myself as someone who is talkative) on a scale from 1 (disagree strongly) to 5 (agree strongly). | baseline to week 7 |
| Change in Fulfilled Life Scale (FLS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simone Bruno | Contact | 608-209-4108 | sbruno3@wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Melanie Boly, MD, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Recruiting | Madison | Wisconsin | 53719 | United States |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Transcranial electrical stimulation with temporal interference (TES-TI) | Device | TES-TI uses specific electrode arrangement patterns to selectively stimulate the brain. Participants will wear an hdEEG (high density electroencephalography) cap which will allow intermittent periods of stimulation from TES-TI. |
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This is a 32-item inventory that asks subjects to respond to various items (e.g., When I look back on my life, I feel deep inner contentment) on a scale from 1 (does not apply at all) to 6 (applies completely) and is designed to assess subjects' feelings of having lived a full life. |
| baseline to week 7 |
| Change in PROMIS Anxiety | This is an 8-item inventory asking subjects to rate from 1-5 the frequency with which they have experienced components of anxiety in the last seven days. Higher scores reflect greater anxiety. | baseline to week 7 |
| Change in PROMIS Depression | This is an 8-item inventory asking subjects to rate from 1-5 the frequency with which they have experienced components of depression in the last seven days. Higher scores reflect greater depression. | baseline to week 7 |
| Change in Perceived Stress Scale (PSS) | This is a 10-item inventory asking subjects to rate from 0-4 the frequency with which they have felt various kinds of stress in the last month. Participants rate each item on a scale ranging from Never (0) to Very often (4). Seven of the items with positive statements are scored in reverse. As the scores obtained from the scale increase, the perceived stress level of the person increases. Scores range from 0-40. | baseline to week 7 |
| Change in Questionnaire for Eudaimonic Well-Being (QEWB) | This is a 21-item inventory asking subjects to rate from 0-4 the extent to which they agree with various statements designed to assess their overall well-being. Scores range from 0-84 with higher scores indicating higher levels of well-being. | baseline to week 7 |
| Cortical activity - change in alpha band power (topical anesthetic vs. no topical anesthetic) | Alpha band power will be measured with hdEEG during stimulation. An increase indicates greater level of ego disengagement. Cortical activity will be compared between sessions that use topical anesthetics and those that do not use topical anesthetics below the sensors to evaluate whether skin receptors are a confounding factor. | week 1, week 2, week 3, final visit (week 7) |
| Cortical activity - change in gamma band power (topical anesthetic vs. no topical anesthetic) | Gamma band power will be measured with hdEEG during stimulation. A decrease indicates greater level of ego disengagement. Cortical activity will be compared between sessions that use topical anesthetics and those that do not use topical anesthetics below the sensors to evaluate whether skin receptors are a confounding factor. | week 1, week 2, week 3, final visit (week 7) |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |