Neuromodulation-assisted Ego-disengagement: The NEURO-EGO Study Stage 1

NCT06601686 | Recruiting DMC FDA Device

• 3 other identifiers: 2023-0613A535100Protocol Version 10/9/25
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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
• Perform cognitive tasks

Conditions

Healthy

Keywords

meditation; brain stimulation

Outcome Measures

Primary Outcomes (3)

• 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).

  Data collected at one study visit (anytime up to 2 weeks on study)

• 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.

  Data collected at one study visit (anytime up to 2 weeks on study)

• 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.

  Data collected at one study visit (anytime up to 2 weeks on study)

Secondary Outcomes (31)

• Change in Big Five Aspects Scale (BFAS)

  baseline to follow up (up to 6 weeks)

• Change in Fulfilled Life Scale (FLS)

  baseline to follow up (up to 6 weeks)

• Change in PROMIS Anxiety

  baseline to follow up (up to 6 weeks)

• Change in PROMIS Depression

  baseline to follow up (up to 6 weeks)

• Change in Perceived Stress Scale (PSS)

  baseline to follow up (up to 6 weeks)

Study Arms (1)

Stimulation

EXPERIMENTAL

Participants will undergo sham, TES or TES-TI stimulation while completing cognitive assessments.

Device: Transcranial electrical stimulation (TES); Device: Transcranial electrical stimulation with temporal interference (TES-TI); Device: Sham stimulation

Interventions

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.

Stimulation

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.

Stimulation

Sham stimulation DEVICE

TES-TI sham includes receiving stimulation from all electrodes at the same frequency. Sham TES will include administration of transcranial random noise stimulation (tRNS), random oscillating current. It will also include periods with no stimulation and a ramping up period followed by no stimulation.

Stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults, ages 18 to 80 of any identified gender
• Medically healthy
• English-speaking (able to provide consent and complete questionnaires)
• Healthy adults with a consistent meditation practice
• Citizen or legal resident

You may not qualify if:

• 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 greater 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)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Tiny Blue Dot Foundation: collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53719, United States

RECRUITING

Related Links

• Neuromodulation-assisted Ego-disengagement: the NEURO-EGO Study Stage 2

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Melanie Boly, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simone Bruno

CONTACT

608-209-4108; sbruno3@wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants will not know whether they receive sham or real stimulation
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: January 8, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)