HealthyNCT06601699
Neuromodulation-assisted Ego-disengagement: The NEURO-EGO Study Stage 2
A study testing Transcranial electrical stimulation (TES) and Transcranial electrical stimulation with temporal interference (TES-TI) in people with Healthy, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Transcranial electrical stimulation (TES) and Transcranial electrical stimulation with temporal interference (TES-TI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2025to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults, ages 18 to 80 of any identified gender
- Medically healthy
- English-speaking (able to provide consent and complete questionnaires)
- Healthy adults who are meditation-naïve
- Citizen or legal resident
Who cannot join
- Any current or past history of neurological disorders or acquired neurological disease (e.g. stroke, traumatic brain injury), including intracranial lesions
- Any current or past history of bipolar disorder and/or hypomania
- Any current or past history of psychosis
- History of head trauma resulting in prolonged loss of consciousness; or a history of great than 3 grade I concussions
- Current history of poorly controlled headaches including intractable or poorly controlled migraines
- Any systemic illness or unstable medical condition that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
Show all 20Show fewer
- History of fainting spells of unknown or undetermined etiology that might constitute seizures
- History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG, or family history of treatment resistant epilepsy with the exception of a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist
- Possible pregnancy. All female participants of child-bearing age are required to have a pregnancy test
- Any metal in the brain, skull or head
- Any contraindications to MRI
- Any medical devices or implants (i.e. cardiac pacemaker, medication infusion pump, cochlear implant, vagal nerve stimulator, dental implants (this includes a permanent retainer)) unless otherwise approved by the responsible MD
- Substance abuse or dependence within the past six months
- Any medication that may alter seizure threshold i.e., ADHD stimulants (Adderall, amphetamine); Tricyclic/atypical antidepressants (Amitriptyline, Dioxepine, Imipramine Maprotiline, Nortriptyline, Bupropion); Antipsychotics (Chlorpromazine, Clozapine), Bronchodilators (theophylline, aminophylline); Antibiotics (fluoroquinolones, imipenem, penicillin, cephalosporins, metronidazole, isoniazid); Antiviral (Valacyclovir, Ritonavir); OTC (Diphenhydramine)
- Claustrophobia (a fear of small or closed places)
- Back problems that would prevent lying flat for up to two hours
- Having experienced a traumatic event that caused lasting distress or required treatment
- Motion sickness
- Any hair braid, dreadlocks, hair pieces, or extensions which cannot be taken out or adjusted to permit comfortable and comprehensive participation before the MRI scans and/or stimulation sessions
- Any head coverings or headdress that participant feels uncomfortable removing for the purposes of the MRI scans and/or stimulation session
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53719
Simone Bruno, 608-209-4108, sbruno3@wisc.edu
Melanie Boly, MD, PhD
About this study
Official title: Neuromodulation-assisted Ego-disengagement: The NEURO-EGO Study
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:
- Complete questionnaires
- Perform a guided meditation task (The Bell Task)
- Wear a high density electrocochleography (hdEEG) cap
- Undergo brain stimulation
Read the detailed description
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):
- Evaluate the relationships between NIBS, ego-disengagement, and trait assessments openness and wellbeing
- Evaluate the effect of the use of topical anesthetics on the EEG response evoked by NIBS
- Conditions
- Healthy
- Being tested
- Transcranial electrical stimulation (TES), Transcranial electrical stimulation with temporal interference (TES-TI)
- Keywords
- meditation, brain stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcranial electrical stimulation (TES); Device: Transcranial electrical stimulation with temporal interference (TES-TI) |
| 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. Receives: Device: Transcranial electrical stimulation (TES); Device: Transcranial electrical stimulation with temporal interference (TES-TI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: week 1, week 2, week 3, final visit (week 7)
Secondary outcomes (8)
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).
Measured: baseline to week 7
Change in Fulfilled Life Scale (FLS)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week 1, week 2, week 3, final visit (week 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start27 Aug 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Tiny Blue Dot Foundation
- Responsible party
- Sponsor
- Investigators
- Melanie Boly, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601699
- Sponsor's protocol ID
- 2023-0613 Stage 2
- Other IDs
- A535100, Protocol Version 4/10/2026
- Status last verified
- Jun 2026
- First submitted
- 10 Sep 2024
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation-assisted Ego-disengagement: The NEURO-EGO Study
- ClinicalTrials.gov ID
- NCT06601699
- Acronym / sponsor ID
- 2023-0613 Stage 2
- Conditions
- Healthy
- Keywords
- meditation, brain stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Tiny Blue Dot Foundation
- Study start
- 27 Aug 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 19 Sep 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.
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:
- Complete questionnaires
- Perform a guided meditation task (The Bell Task)
- Wear a high density electrocochleography (hdEEG) cap
- Undergo brain stimulation
Detailed description
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):
- Evaluate the relationships between NIBS, ego-disengagement, and trait assessments openness and wellbeing
- Evaluate the effect of the use of topical anesthetics on the EEG response evoked by NIBS
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimulation | Experimental | Device: Transcranial electrical stimulation (TES), Device: Transcranial electrical stimulation with temporal interference (TES-TI)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. |
| Sham stimulation | Sham comparator | Device: Transcranial electrical stimulation (TES), Device: Transcranial electrical stimulation with temporal interference (TES-TI)Participants will undergo sham stimulation in 5-minute blocks up to eight times a day on three separate days each separated by one week. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults, ages 18 to 80 of any identified gender
- Medically healthy
- English-speaking (able to provide consent and complete questionnaires)
- Healthy adults who are meditation-naïve
- Citizen or legal resident
Key exclusion criteria (20 listed)
- Any current or past history of neurological disorders or acquired neurological disease (e.g. stroke, traumatic brain injury), including intracranial lesions
- Any current or past history of bipolar disorder and/or hypomania
- Any current or past history of psychosis
- History of head trauma resulting in prolonged loss of consciousness; or a history of great than 3 grade I concussions
- Current history of poorly controlled headaches including intractable or poorly controlled migraines
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 |
|---|---|---|
| Transcranial electrical stimulation (TES)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. | Device | Sham stimulation, Stimulation |
| Transcranial electrical stimulation with temporal interference (TES-TI)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. | Device | Sham stimulation, Stimulation |
Primary outcome
Ego-Disengagement scale
Time frame: baseline, week 1, week 2, week 3, week 7
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).
Cortical activity - change in gamma band power
Time frame: week 1, week 2, week 3, final visit (week 7)
Gamma band power will be measured with hdEEG during stimulation. A decrease indicates greater level of ego disengagement.
Cortical activity - change in alpha band power
Time frame: week 1, week 2, week 3, final visit (week 7)
Alpha band power will be measured with hdEEG during stimulation. An increase indicates greater level of ego disengagement.
8 secondary outcomes
Change in Big Five Aspects Scale (BFAS)
Time frame: baseline to week 7
Change in Fulfilled Life Scale (FLS)
Time frame: baseline to week 7
Change in PROMIS Anxiety
Time frame: baseline to week 7
Change in PROMIS Depression
Time frame: baseline to week 7
Change in Perceived Stress Scale (PSS)
Time frame: baseline to week 7
Change in Questionnaire for Eudaimonic Well-Being (QEWB)
Time frame: baseline to week 7
Cortical activity - change in alpha band power (topical anesthetic vs. no topical anesthetic)
Time frame: week 1, week 2, week 3, final visit (week 7)
Cortical activity - change in gamma band power (topical anesthetic vs. no topical anesthetic)
Time frame: week 1, week 2, week 3, final visit (week 7)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 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.
Melanie Boly, MD, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial electrical stimulation (TES) and Transcranial electrical stimulation with temporal interference (TES-TI) in people with Healthy, run by University of Wisconsin, Madison 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 5 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 18 Jun 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simone Bruno (608-209-4108, sbruno3@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ego-Disengagement scale (time frame: baseline, week 1, week 2, week 3, week 7). The study lists 3 primary outcomes in all. 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 18 Jun 2026.