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

University of Wisconsin (UW)

Status: Enrolling

Conditions: Healthy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06601699

A535100 (Other Identifier)

Protocol Version 10/9/2025 (Other Identifier)

2023-0613 Stage 2

Details and patient eligibility

About

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

Full 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

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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48 participants in 2 patient groups

Stimulation

Experimental group

Description:

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.

Treatment:

Device: Transcranial electrical stimulation (TES)

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

Sham stimulation

Sham Comparator group

Description:

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

Treatment:

Device: Transcranial electrical stimulation (TES)

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