Neuromodulation-assisted Ego-disengagement: The NEURO-EGO Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Ego-Disengagement scale
研究概览
简要总结
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
详细描述
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=22) 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Participants will not know whether they receive sham or real stimulation
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
- •Back problems that would prevent lying flat for up to two hours
- •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
研究组 & 干预措施
Stimulation
Participants will undergo sham, TES or TES-TI stimulation while completing cognitive assessments.
干预措施: Transcranial electrical stimulation (TES) (Device)
Stimulation
Participants will undergo sham, TES or TES-TI stimulation while completing cognitive assessments.
干预措施: Transcranial electrical stimulation with temporal interference (TES-TI) (Device)
Stimulation
Participants will undergo sham, TES or TES-TI stimulation while completing cognitive assessments.
干预措施: Sham stimulation (Device)
结局指标
主要结局
Ego-Disengagement scale
时间窗: Data collected at one study visit (anytime up to 2 weeks on study)
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).
Cortical activity - change in gamma band power
时间窗: Data collected at one study visit (anytime up to 2 weeks on study)
Gamma band power will be measured with hdEEG during stimulation. A decrease indicates greater level of ego disengagement.
Cortical activity - change in alpha band power
时间窗: Data collected at one study visit (anytime up to 2 weeks on study)
Alpha band power will be measured with hdEEG during stimulation. An increase indicates greater level of ego disengagement.
次要结局
- 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))
- Change in Questionnaire for Eudaimonic Well-Being (QEWB)(baseline to follow up (up to 6 weeks))
- Change in Psychological Wellbeing Scale (PWB)(baseline to follow up (up to 6 weeks))
- Change in IQSS Flourishing Measure(baseline to follow up (up to 6 weeks))
- Change in Metacognitive Processes of Decentering Scale (MPoD)(baseline to follow up (up to 6 weeks))
- Change in Experiences Questionnaire (EQ)(baseline to follow up (up to 6 weeks))
- Change in Self-Reflection Insight Scale (SRIS)(baseline to follow up (up to 6 weeks))
- Change in Non-Attachment Scale (NAS)(baseline to follow up (up to 6 weeks))
- Change in Non-Attachment to Self Scale (NTS)(baseline to follow up (up to 6 weeks))
- Change in Five Facet Mindfulness Questionnaire (FFMQ)(baseline to follow up (up to 6 weeks))
- Change in Drexel Defusion Scale (DDS)(baseline to follow up (up to 6 weeks))
- Change in Relationship Questionnaire (RQ)(baseline to follow up (up to 6 weeks))
- Change in UCLA Loneliness Scale (ULS)(baseline to follow up (up to 6 weeks))
- Change in Social Connectedness Scale (SCS)(baseline to follow up (up to 6 weeks))
- Change in Attachment Style Questionnaire (ASQ)(baseline to follow up (up to 6 weeks))
- Change in Emotional Intelligence Scale (EIS)(baseline to follow up (up to 6 weeks))
- Change in Barratt Impulsiveness Scale (BIS-11)(baseline to follow up (up to 6 weeks))
- Change in Dickman Impulsivity Inventory (DII)(baseline to follow up (up to 6 weeks))
- Change in Vividness of Visual Imagery Questionnaire (VVIQ)(baseline to follow up (up to 6 weeks))
- Implicit Association Task: Response Time(Data collected at one study visit (anytime up to 2 weeks on study))
- Implicit Association Task: Accuracy Reported as the Number of Misclassifications(Data collected at one study visit (anytime up to 2 weeks on study))
- Implicit Association Task: D-Score(Data collected at one study visit (anytime up to 2 weeks on study))
- Rapid Discrimination Task: Speed(Data collected at one study visit (anytime up to 2 weeks on study))
- Rapid Discrimination Task: Accuracy(Data collected at one study visit (anytime up to 2 weeks on study))
- Spontaneous Mentation Task(Data collected at one study visit (anytime up to 2 weeks on study))
- Automatic Emotion Regulation Task(Data collected at one hour MRI visit (scheduled within 2 weeks on study))
- Resting State Task(Data collected at one hour MRI visit (scheduled within 2 weeks on study))
- 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))
- Change in Questionnaire for Eudaimonic Well-Being (QEWB)(baseline to follow up (up to 6 weeks))
- Change in Psychological Wellbeing Scale (PWB)(baseline to follow up (up to 6 weeks))
- Change in IQSS Flourishing Measure(baseline to follow up (up to 6 weeks))
- Change in Metacognitive Processes of Decentering Scale (MPoD)(baseline to follow up (up to 6 weeks))
- Change in Experiences Questionnaire (EQ)(baseline to follow up (up to 6 weeks))
- Change in Self-Reflection Insight Scale (SRIS)(baseline to follow up (up to 6 weeks))
- Change in Non-Attachment Scale (NAS)(baseline to follow up (up to 6 weeks))
- Change in Non-Attachment to Self Scale (NTS)(baseline to follow up (up to 6 weeks))
- Change in Five Facet Mindfulness Questionnaire (FFMQ)(baseline to follow up (up to 6 weeks))
- Change in Drexel Defusion Scale (DDS)(baseline to follow up (up to 6 weeks))
- Change in Relationship Questionnaire (RQ)(baseline to follow up (up to 6 weeks))
- Change in UCLA Loneliness Scale (ULS)(baseline to follow up (up to 6 weeks))
- Change in Social Connectedness Scale (SCS)(baseline to follow up (up to 6 weeks))
- Change in Attachment Style Questionnaire (ASQ)(baseline to follow up (up to 6 weeks))
- Change in Emotional Intelligence Scale (EIS)(baseline to follow up (up to 6 weeks))
- Change in Barratt Impulsiveness Scale (BIS-11)(baseline to follow up (up to 6 weeks))
- Change in Dickman Impulsivity Inventory (DII)(baseline to follow up (up to 6 weeks))
- Change in Vividness of Visual Imagery Questionnaire (VVIQ)(baseline to follow up (up to 6 weeks))
- Implicit Association Task: Response Time(Data collected at one study visit (anytime up to 2 weeks on study))
- Implicit Association Task: Accuracy Reported as the Number of Misclassifications(Data collected at one study visit (anytime up to 2 weeks on study))
- Implicit Association Task: D-Score(Data collected at one study visit (anytime up to 2 weeks on study))
- Rapid Discrimination Task: Speed(Data collected at one study visit (anytime up to 2 weeks on study))
- Rapid Discrimination Task: Accuracy(Data collected at one study visit (anytime up to 2 weeks on study))
- Spontaneous Mentation Task(Data collected at one study visit (anytime up to 2 weeks on study))
- Automatic Emotion Regulation Task(Data collected at one hour MRI visit (scheduled within 2 weeks on study))
- Resting State Task(Data collected at one hour MRI visit (scheduled within 2 weeks on study))