Clinical trial NCT06601686: Neuromodulation-assisted Ego-disengagement: The NEURO-EGO Study Stage 1
Official title: Neuromodulation-assisted Ego-disengagement: The NEURO-EGO Study
Study type: INTERVENTIONAL
Overall status: 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: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
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
* Perform cognitive tasks

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.

Phase 1 (registered to this record) involves administering 2 distinct types of deep brain stimulation techniques to a small sample (N=12) of experienced meditators to determine which type of neuromodulation, when focused on disruption of posteromedial cortex (PMC) activity, most robustly facilitates positive ego-disengagement compared to sham; and to discern the region of the PMC where disruption is most effective in achieving ego disengagement.

Phase 2 (registered to a separate record, NCT06601699) will use the most effective stimulation and PMC parameters to meditation naïve healthy adults.

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 with a consistent meditation practice

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

Primary outcomes:
measure: Ego-Disengagement scale
timeFrame: Data collected at one study visit (anytime up to 2 weeks on study)
measure: Cortical activity - change in gamma band power
timeFrame: Data collected at one study visit (anytime up to 2 weeks on study)
measure: Cortical activity - change in alpha band power
timeFrame: Data collected at one study visit (anytime up to 2 weeks on study)
Secondary outcomes:
measure: Change in Big Five Aspects Scale (BFAS)
timeFrame: baseline to follow up (up to 6 weeks)
measure: Change in Fulfilled Life Scale (FLS)
timeFrame: baseline to follow up (up to 6 weeks)
measure: Change in PROMIS Anxiety
timeFrame: baseline to follow up (up to 6 weeks)
measure: Change in PROMIS Depression
timeFrame: baseline to follow up (up to 6 weeks)
measure: Change in Perceived Stress Scale (PSS)
timeFrame: baseline to follow up (up to 6 weeks)
measure: Change in Questionnaire for Eudaimonic Well-Being (QEWB)
timeFrame: baseline to follow up (up to 6 weeks)
measure: Change in Psychological Wellbeing Scale (PWB)
timeFrame: baseline to follow up (up to 6 weeks)
measure: Change in IQSS Flourishing Measure
timeFrame: baseline to follow up (up to 6 weeks)
measure: Change in Metacognitive Processes of Decentering Scale (MPoD)
timeFrame: baseline to follow up (up to 6 weeks)
measure: Change in Experiences Questionnaire (EQ)
timeFrame: baseline to follow up (up to 6 weeks)
measure: Change in Self-Reflection Insight Scale (SRIS)
timeFrame: baseline to follow up (up to 6 weeks)
measure: Change in Non-Attachment Scale (NAS)
timeFrame: baseline to follow up (up to 6 weeks)
measure: Change in Non-Attachment to Self Scale (NTS)
timeFrame: baseline to follow up (up to 6 weeks)
measure: Change in Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: baseline to follow up (up to 6 weeks)
measure: Change in Drexel Defusion Scale (DDS)
timeFrame: baseline to follow up (up to 6 weeks)
measure: Change in Relationship Questionnaire (RQ)
timeFrame: baseline to follow up (up to 6 weeks)
measure: Change in UCLA Loneliness Scale (ULS)
timeFrame: baseline to follow up (up to 6 weeks)
measure: Change in Social Connectedness Scale (SCS)
timeFrame: baseline to follow up (up to 6 weeks)
measure: Change in Attachment Style Questionnaire (ASQ)
timeFrame: baseline to follow up (up to 6 weeks)
measure: Change in Emotional Intelligence Scale (EIS)
timeFrame: baseline to follow up (up to 6 weeks)
measure: Change in Barratt Impulsiveness Scale (BIS-11)
timeFrame: baseline to follow up (up to 6 weeks)
measure: Change in Dickman Impulsivity Inventory (DII)
timeFrame: baseline to follow up (up to 6 weeks)
measure: Change in Vividness of Visual Imagery Questionnaire (VVIQ)
timeFrame: baseline to follow up (up to 6 weeks)
measure: Implicit Association Task: Response Time
timeFrame: Data collected at one study visit (anytime up to 2 weeks on study)
measure: Implicit Association Task: Accuracy Reported as the Number of Misclassifications
timeFrame: Data collected at one study visit (anytime up to 2 weeks on study)
measure: Implicit Association Task: D-Score
timeFrame: Data collected at one study visit (anytime up to 2 weeks on study)
measure: Rapid Discrimination Task: Speed
timeFrame: Data collected at one study visit (anytime up to 2 weeks on study)
measure: Rapid Discrimination Task: Accuracy
timeFrame: Data collected at one study visit (anytime up to 2 weeks on study)
measure: Spontaneous Mentation Task
timeFrame: Data collected at one study visit (anytime up to 2 weeks on study)
measure: Automatic Emotion Regulation Task
timeFrame: Data collected at one hour MRI visit (scheduled within 2 weeks on study)
measure: Resting State Task
timeFrame: Data collected at one hour MRI visit (scheduled within 2 weeks on study)
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: