Clinical trial NCT06601699: Neuromodulation-assisted Ego-disengagement: The NEURO-EGO Study Stage 2
Official title: Neuromodulation-assisted Ego-disengagement: The NEURO-EGO Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Keywords: meditation
brain stimulation
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Tiny Blue Dot Foundation
First posted: 2024-09-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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

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

Eligibility criteria: 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

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 \&gt;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) 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
* Severe motion sickness
* Fear of heights
* Exposure to traumatic events

Primary outcomes:
measure: Ego-Disengagement scale
timeFrame: baseline, week 1, week 2, week 3, week 7
measure: Cortical activity - change in gamma band power
timeFrame: week 1, week 2, week 3, final visit (week 7)
Secondary outcomes:
measure: Change in Big Five Aspects Scale (BFAS)
timeFrame: baseline to week 3
measure: Change in Fulfilled Life Scale (FLS)
timeFrame: baseline to week 3
measure: Change in PROMIS Anxiety
timeFrame: baseline to week 3
measure: Change in PROMIS Depression
timeFrame: baseline to week 3
measure: Change in Perceived Stress Scale (PSS)
timeFrame: baseline to week 3
measure: Change in Questionnaire for Eudaimonic Well-Being (QEWB)
timeFrame: baseline to week 3
measure: Cortical activity - change in alpha band power (topical anesthetic vs. no topical anesthetic)
timeFrame: week 1, week 2, week 3, final visit (week 7)
measure: Cortical activity - change in gamma band power (topical anesthetic vs. no topical anesthetic)
timeFrame: week 1, week 2, week 3, final visit (week 7)
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Melanie Boly, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: