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
- 48
- 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
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 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):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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 who are meditation-naïve
- •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 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
研究组 & 干预措施
Sham stimulation
Participants will undergo sham stimulation in 5-minute blocks up to eight times a day on three separate days each separated by one week.
干预措施: Transcranial electrical stimulation (TES) (Device)
Sham stimulation
Participants will undergo sham stimulation in 5-minute blocks up to eight times a day on three separate days each separated by one week.
干预措施: Transcranial electrical stimulation with temporal interference (TES-TI) (Device)
Stimulation
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.
干预措施: Transcranial electrical stimulation (TES) (Device)
Stimulation
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.
干预措施: Transcranial electrical stimulation with temporal interference (TES-TI) (Device)
结局指标
主要结局
Ego-Disengagement scale
时间窗: baseline, week 1, week 2, week 3, week 7
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: week 1, week 2, week 3, final visit (week 7)
Gamma band power will be measured with hdEEG during stimulation. A decrease indicates greater level of ego disengagement.
次要结局
- Change in Big Five Aspects Scale (BFAS)(baseline to week 3)
- Change in Fulfilled Life Scale (FLS)(baseline to week 3)
- Change in PROMIS Anxiety(baseline to week 3)
- Change in PROMIS Depression(baseline to week 3)
- Change in Perceived Stress Scale (PSS)(baseline to week 3)
- Change in Questionnaire for Eudaimonic Well-Being (QEWB)(baseline to week 3)
- Cortical activity - change in alpha band power (topical anesthetic vs. no topical anesthetic)(week 1, week 2, week 3, final visit (week 7))
- Cortical activity - change in gamma band power (topical anesthetic vs. no topical anesthetic)(week 1, week 2, week 3, final visit (week 7))