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Neuromodulation-assisted Ego-disengagement: The NEURO-EGO Study Stage 2

NCT ID: NCT06601699

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-27

Study Completion Date

2028-07-31

Brief Summary

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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:

* Complete questionnaires
* Perform a guided meditation task (The Bell Task)
* Wear a high density electrocochleography (hdEEG) cap
* Undergo brain stimulation

Detailed Description

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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

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Healthy

Keywords

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meditation brain stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Stimulation

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.

Group Type EXPERIMENTAL

Transcranial electrical stimulation (TES)

Intervention Type 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)

Intervention Type 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.

Sham stimulation

Participants will undergo sham stimulation in 5-minute blocks up to eight times a day on three separate days each separated by one week.

Group Type SHAM_COMPARATOR

Transcranial electrical stimulation (TES)

Intervention Type 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)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.)
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tiny Blue Dot Foundation

OTHER

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Melanie Boly, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin

Madison, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Simone Bruno

Role: CONTACT

Phone: 608-209-4108

Email: [email protected]

Facility Contacts

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Simone Bruno

Role: primary

Other Identifiers

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A535100

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 10/9/2025

Identifier Type: OTHER

Identifier Source: secondary_id

2023-0613 Stage 2

Identifier Type: -

Identifier Source: org_study_id