Temporal Interference for Thalamocortical Activity and Network Modulation
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in thalamocortical functional connectivity (FC): resting state fMRI
研究概览
简要总结
The goal of this clinical trial is to find out whether a type of electrical brain stimulation, called temporal interference stimulation, can temporarily change the way different parts of the brain communicate with each other.
Participants will:
- Complete two stimulation phases - overnight and during wakefulness
- Undergo two MRIs per study phase
详细描述
This study will evaluate the effectiveness of personalized thalamic temporal interference transcranial electrical stimulation (TI-TES) to modulate thalamocortical activity and connectivity in healthy adults. Using a within-subject, counterbalanced crossover design, participants will complete two stimulation phases: (1) repeated overnight TI-TES or sham stimulation during NREM sleep and (2) repeated during quiet wakefulness. Each phase consists of two sessions. Phases are separated by a ≥4-week washout. Resting-state functional magnetic resonance imaging (fMRI) will be acquired before and after each phase to assess sustained changes in thalamocortical functional connectivity, with high-density EEG providing secondary measures of brain-state-specific oscillatory modulation (sigma/spindles in sleep, alpha in wake).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18-50
- •Medically healthy
- •U.S. citizen or holding permanent resident status
- •English-speaking
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 (including clinically significant findings identified in first MRI)
- •History of inpatient psychiatric hospitalization
- •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 seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG, or family history of treatment resistant epilepsy except for a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist
- •Possible pregnancy or plan to become pregnant in the next 6 months (self reported)
- •Any metal in the head
- •Any medical devices or implants (i.e. cardiac pacemaker, medication infusion pump, cochlear implant, vagal nerve stimulator)
- •Dental implants
- •Permanent retainers
- •Any hair braid, dreadlocks, hair pieces, or extensions which cannot be taken out before the study sessions
- •Any head coverings or headdress that participant feels uncomfortable removing for the purposes of study sessions
- •Any medication that may alter seizure threshold taken during the study i.e., Attention-deficit/hyperactivity disorder (ADHD) stimulants (Adderall, amphetamine); Tricyclic/atypical antidepressants (amitriptyline, doxepin, imipramine, maprotiline, nortriptyline, bupropion); SSRIs (Escitalopram, Fluoxetine, Sertraline); Antipsychotics (chlorpromazine, clozapine), Bronchodilators (theophylline, aminophylline); Antibiotics (fluoroquinolones, imipenem, penicillin, cephalosporins, metronidazole, isoniazid); Antivirals (valacyclovir, ritonavir); over the counter antihistamines (diphenhydramine, Benadryl); Estradiol-based birth control
- •Claustrophobia (a fear of small or closed places)
- •Back problems that would prevent lying flat for up to two hours
- •Regular night-shift work (second or third shift)
- •Sleep apnea or other sleep disorder (self-reported)
研究组 & 干预措施
Stimulation
Participants will complete two stimulation phases-overnight TI-TES during non-rapid eye movement (NREM) sleep and TI-TES during quiet wakefulness
干预措施: Temporal Interference Transcranial electrical stimulation (TI-TES) (Device)
Sham stimulation
~10 participants will be assigned to sham stimulation
干预措施: Sham stimulation (Device)
结局指标
主要结局
Change in thalamocortical functional connectivity (FC): resting state fMRI
时间窗: Pre- to post-intervention, up to 2 weeks
Resting-state fMRI will be used to assess changes in thalamocortical functional connectivity before and after repeated thalamic TI-TES delivered during NREM sleep and quiet wakefulness.
Difference in magnitude of FC changes between sleep and wake
时间窗: 8 weeks
The magnitude of FC changes between sleep and wake stimulation phases will be evaluated.
Difference in spatial distribution of FC changes between sleep and wake
时间窗: 8 weeks
The spatial distribution of FC changes between sleep and wake stimulation phases will be evaluated.
次要结局
- Change in sigma-band power (EEG, sleep phase)(During and after each overnight stimulation session, up to 1 week)
- Change in alpha band power during wake stimulation sessions(During and after each wake stimulation session, up to 1 week)
- Return to baseline thalamocortical FC(8 weeks)
- Change in structural thalamocortical connectivity(Pre- to post-intervention, up to 2 weeks)
- Change in mood(Baseline to 12 weeks)
- Change in Boston Cognitive Assessment (BoCA)(Baseline to 12 weeks)
- Change in spindle characteristics: Density(Up to 1 week)
- Change in spindle characteristics: Amplitude(Up to 1 week)
- Change in spindle characteristics: Duration(Up to 1 week)