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

Официальное название

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

Обзор

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

Подробное описание

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

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Ego-Disengagement scale [Срок оценки: baseline, week 1, week 2, week 3, week 7]
• Cortical activity - change in gamma band power [Срок оценки: week 1, week 2, week 3, final visit (week 7)]
• Cortical activity - change in alpha band power [Срок оценки: week 1, week 2, week 3, final visit (week 7)]

Вторичные конечные точки (8)

• Change in Big Five Aspects Scale (BFAS) [Срок оценки: baseline to week 7]
• Change in Fulfilled Life Scale (FLS) [Срок оценки: baseline to week 7]
• Change in PROMIS Anxiety [Срок оценки: baseline to week 7]
• Change in PROMIS Depression [Срок оценки: baseline to week 7]
• Change in Perceived Stress Scale (PSS) [Срок оценки: baseline to week 7]
• Change in Questionnaire for Eudaimonic Well-Being (QEWB) [Срок оценки: baseline to week 7]
• Cortical activity - change in alpha band power (topical anesthetic vs. no topical anesthetic) [Срок оценки: week 1, week 2, week 3, final visit (week 7)]
• Cortical activity - change in gamma band power (topical anesthetic vs. no topical anesthetic) [Срок оценки: week 1, week 2, week 3, final visit (week 7)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Простое слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• University of Wisconsin — Madison

Идентификаторы

NCT: NCT06601699 · 2023-0613 Stage 2 · A535100 · Protocol Version 4/10/2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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