Mechanistic Validation of Human Multipolar TES-TI: Amplitude Modulation, Frequency, and Benchmarking
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in band-limited, topography-resolved EEG spectral power during stimulation for conditions in Session A
研究概览
简要总结
This study is to find out whether and how a type of non-invasive electrical brain stimulation called transcranial electrical stimulation with temporal interference (TES-TI) can temporarily change brain activity in healthy adults. A structural MRI scan will be used to customize where the stimulation electrodes are placed for each participant to deliver TES-TI during three afternoon sessions at rest with eyes closed. Brain activity is recorded with high-density EEG. Up to 24 participants will be enrolled and on study for 3 to 12 weeks.
详细描述
This is an experimental study using a within-subject, single-blind, randomized, counterbalanced crossover design in which each participant serves as their own control. Healthy adults will complete (or provide an existing) structural MRI scan (T1/T2) to support individualized electric-field modeling and personalized montage optimization for thalamic targeting, followed by three afternoon stimulation sessions with simultaneous high-density EEG during eyes-closed wakefulness; sessions will be scheduled on separate days at least one week apart. Each session includes four stimulation conditions administered in randomized/counterbalanced order, with each condition consisting of a fixed 3-minute pre-stimulation baseline, 3-minute stimulation period, and 3-minute post-stimulation recording to enable STIM-PRE and POST-PRE comparisons.
- Session A tests amplitude-modulation specificity (in-phase mTI, a mixed unipolar+HF condition with the same montage/current, a carrier-only HF control, and sham)
- Session B benchmarks in-phase mTI against unipolar TES-TI at 5 mA and 8 mA (plus sham); and
- Session C characterizes frequency dependence of in-phase mTI (10, 50, 130 Hz; plus sham).
Primary Objectives:
- Determine whether active multipolar TES-TI (mTI) produces envelope-driven EEG effects (primary contrast: STIM-PRE) by comparing in-phase mTI to SHAM, to a carrier-only no-envelope high-frequency (HF) control, and to a mixed unipolar+HF condition (same montage/current; one pair as unipolar TES-TI producing an AM envelope, the other pair as a non-interacting HF carrier with no envelope contribution).
- Benchmark mTI against unipolar TES-TI across stimulation intensity by comparing in-phase mTI to unipolar TES-TI at 5 mA and 8 mA, each evaluated relative to SHAM (primary contrast: STIM-PRE), and estimating effect sizes to inform future study design.
- Characterize envelope-frequency dependence of in-phase mTI effects by comparing EEG spectral power changes across 10, 50, and 130 Hz conditions (each relative to SHAM; primary contrast: STIM-PRE).
Secondary Objectives: 4. Assess persistence of stimulation-related EEG changes by quantifying post-stimulation effects (POST-PRE) across conditions (in-phase, mixed unipolar+HF, HF, unipolar) and sessions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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
- •Medically healthy (based on self-report and study team review)
- •U.S. citizen or holding permanent resident status
- •English-speaking (able to provide consent and complete questionnaires)
排除标准
- •Current or past history of clinically significant neurological disorder or acquired neurological disease (e.g., stroke, traumatic brain injury), including intracranial lesions (including clinically significant findings identified on the structural MRI)
- •History of inpatient psychiatric hospitalization
- •History of head trauma resulting in prolonged loss of consciousness; or a history of >3 grade I concussions
- •Current poorly controlled headaches, including intractable or frequent 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 or body
- •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
- •Current use of medications known to substantially lower seizure threshold, specifically chlorpromazine, clozapine, bupropion, clomipramine, or maprotiline; or other medications at doses known to substantially lower seizure threshold in the judgment of the PI
- •Active scalp lesions, broken skin, or skin conditions at planned electrode sites that would preclude safe electrode application
- •Claustrophobia (a fear of small or closed places)
- •Back problems that would prevent lying flat for up to two hours
研究组 & 干预措施
Session A: Amplitude Modulation Specificity
hdEEG setup; eyes-closed wakefulness 4 conditions in randomized order:
- in-phase mTI (10 Hz)
- mixed unipolar+HF
- HF control (no envelope)
- SHAM PRE 3 min / STIM 3 min / POST 3 min per condition
Adverse events assessment
干预措施: TES-TI with hdEEG (Device)
Session B: Benchmarking
hdEEG setup; eyes-closed wakefulness 4 conditions in randomized order:
- in-phase mTI (10 Hz)
- unipolar TES-TI 5 mA
- unipolar TES-TI 8 mA
- SHAM PRE 3 min / STIM 3 min / POST 3 min per condition
Adverse events assessment
干预措施: TES-TI with hdEEG (Device)
Session C: Frequency Dependence
hdEEG setup; eyes-closed wakefulness 4 conditions in randomized order:
- in-phase mTI at 10 Hz
- in-phase mTI at 50 Hz
- in-phase mTI at 130 Hz
- SHAM PRE 3 min / STIM 3 min / POST 3 min per condition
Adverse events assessment
干预措施: TES-TI with hdEEG (Device)
结局指标
主要结局
Change in band-limited, topography-resolved EEG spectral power during stimulation for conditions in Session A
时间窗: data collected for 3 minutes prior to stimulation and 3 minutes during stimulation for each of 4 conditions during Session A (approximately 3 hours long)
Change in band-limited, topography-resolved EEG spectral power during stimulation (STIM-PRE) for in-phase mTI compared to SHAM, HF control, and the mixed unipolar+HF condition.
Change in band-limited, topography-resolved EEG spectral power during stimulation for conditions in Session B
时间窗: data collected for 3 minutes prior to stimulation and 3 minutes during stimulation for each of 4 conditions during Session B (approximately 3 hours long)
Change in band-limited, topography-resolved EEG spectral power during stimulation (STIM-PRE) for in-phase mTI compared to unipolar TES-TI at 5 mA, and 8 mA, relative to SHAM.
Change in band-limited, topography-resolved EEG spectral power during stimulation for conditions in Session C
时间窗: data collected for 3 minutes prior to stimulation and 3 minutes during stimulation for each of 4 conditions during Session C (approximately 3 hours long)
Change in band-limited, topography-resolved EEG spectral power during stimulation (STIM-PRE) for in-phase mTI at 10 Hz, 50 Hz, and 130 Hz, relative to SHAM.
次要结局
- Change in band-limited, topography-resolved EEG spectral power in the post-stimulation interval (POST-PRE) across all tested conditions(data collected for 3 minutes prior to stimulation and 3 minutes post stimulation for each of 4 conditions during each of 3 sessions (each session is approximately 3 hours long, with at least one week between sessions))