Temporal Interference Methods for Non-invasive Deep Brain Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
This grant aims to develop a line of research using temporal interference (TI) electrical neurostimulation technology to understand the causal role of deep brain structures in cognition. In the short term, the investigators aim to validate and characterize the effects of TI on brain activity as measured by fMRI and demonstrate its ability to focally stimulate deep brain regions without affecting overlying cortex. In the longer term, investigators aim to use these data to resolve longstanding debates about the function of deeper brain regions and lay the foundation for future clinical applications of TI for treating addiction, Obsessive-Compulsive Disorder (OCD), Parkinson's disease, and other disorders involving deep brain dysfunction. The grant supports 2 distinct aims, each of which will be evaluated through a series of independent studies.
详细描述
Through the grant's duration, the investigators hypothesize that temporal interference (TI) electrical neurostimulation will be well tolerated and effective at focally manipulating deep brain activity as measured by functional MRI (fMRI) BOLD signals. The investigators will investigate whether TI stimulation can increase BOLD activity in targeted deep brain regions including the nucleus accumbens (NAcc) and dorsal anterior cingulate cortex (dACC), and whether this stimulation can influence cognitive functions controlled by these regions. TI works by applying alternating currents of slightly different frequencies through multiple electrode pairs, creating an interference pattern that can stimulate deep brain regions without significantly affecting superficial cortical areas. This method is similar to traditional transcranial direct current stimulation (tDCS), however TI can stimulate deeper brain structures that tDCS cannot reach effectively. The study is broken up into two main aims with multiple sub-studies. In Aim 1, the investigators will characterize the effects of TI on fMRI BOLD signals, test different beat frequencies, and compare TI effects in the nucleus accumbens versus dorsal anterior cingulate cortex. In Aim 2, the investigators will apply TI to the dorsal anterior cingulate cortex to test causal theories about its role in cognitive control, conflict monitoring, risk avoidance, and foraging behavior using established cognitive tasks while subjects undergo fMRI scanning.
Study 1.3 (Aim 1, Study 1.3) will test whether TI can focally modulate activity in the dorsal anterior cingulate cortex, around MNI coordinates 0, 30, 30, as measured by fMRI BOLD signal. Healthy subjects (n=30) will complete a single study visit during which they will undergo fMRI while receiving TI stimulation through carbon fiber electrodes attached to the scalp with conductive gel. Electrode placement may vary by participant to optimize dACC targeting using individualized finite element modeling.
Participants will receive active and sham TI stimulation at a selected beat frequency potentially including 5 Hz, 30 Hz, 40 Hz, or another frequency in the 1-100 Hz range. Stimulation will follow an on/off sequence of 2 minutes on, 2 minutes off, 2 minutes on, and 2 minutes off, with 30-second ramp up and ramp down periods beginning at the start of each 2-minute stimulation period. Study 1.3 will also examine whether increased stimulation intensity improves modulation of BOLD activity in the dACC. Stimulation may be delivered up to ±5 mA per channel, corresponding to 10 mA peak-to-peak, with the second stimulation channel linearly scaled based on individualized modeling to maintain optimal targeting. Active and sham stimulation blocks will be counterbalanced across subjects.
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
- •Between the ages of 18 and 50
- •Must have at least a 6th grade education
- •Ability to speak and read English for all phases
排除标准
- •Currently taking psychotropic medications for ADHD, other mental illness, or medications for cancer
- •History of epilepsy or seizure disorders
- •History of migraines or other neurological syndromes
- •History of AIDS (due to potential cognitive deficits)
- •History of head trauma or cognitive impairments
- •Personal experiences consistent with symptoms of psychosis (e.g., hallucinations, delusions of control or special powers)
- •History of skull defects (e.g., holes bored into the skull or known cranial fissures)
- •Metal implants in the head or under the scalp
- •Does not meet fMRI safety screening criteria (e.g., metal implants in the body, permanent jewelry, tattoos on the head or neck)
- •Uses an intrauterine device (IUD) for birth control and cannot provide documentation to verify MRI safety
- •Pregnancy (self-reported; no pregnancy test administered)
- •Weight over 440 lbs (scanner weight limit)
- •Presence of pacemakers
研究组 & 干预措施
dACC 20Hz Sham then Active; Comparison Frequency Sham then Active
Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using scalp electrodes. The stimulation order is: 20 Hz TI Sham, 20 Hz TI Active, selected comparison frequency TI Sham, then selected comparison frequency TI Active. The comparison frequency will be in the 1-100 Hz range.
干预措施: Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Active (Device)
dACC 20Hz Sham then Active; Comparison Frequency Sham then Active
Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using scalp electrodes. The stimulation order is: 20 Hz TI Sham, 20 Hz TI Active, selected comparison frequency TI Sham, then selected comparison frequency TI Active. The comparison frequency will be in the 1-100 Hz range.
干预措施: Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI Sham (Device)
dACC Comparison Frequency Sham then Active; 20Hz Sham then Active
Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using scalp electrodes. The stimulation order is: selected comparison frequency TI Sham, selected comparison frequency TI Active, 20 Hz TI Sham, then 20 Hz TI Active. The comparison frequency will be in the 1-100 Hz range.
干预措施: Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI Sham (Device)
dACC Comparison Frequency Sham then Active; 20Hz Sham then Active
Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using scalp electrodes. The stimulation order is: selected comparison frequency TI Sham, selected comparison frequency TI Active, 20 Hz TI Sham, then 20 Hz TI Active. The comparison frequency will be in the 1-100 Hz range.
干预措施: Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Sham (Device)
dACC Comparison Frequency Active then Sham; 20Hz Active then Sham
Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using scalp electrodes. The stimulation order is: selected comparison frequency TI Active, selected comparison frequency TI Sham, 20 Hz TI Active, then 20 Hz TI Sham. The comparison frequency will be in the 1-100 Hz range.
干预措施: Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Sham (Device)
dACC 20Hz Sham then Active; Comparison Frequency Sham then Active
Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using scalp electrodes. The stimulation order is: 20 Hz TI Sham, 20 Hz TI Active, selected comparison frequency TI Sham, then selected comparison frequency TI Active. The comparison frequency will be in the 1-100 Hz range.
干预措施: Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Sham (Device)
dACC 20Hz Sham then Active; Comparison Frequency Sham then Active
Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using scalp electrodes. The stimulation order is: 20 Hz TI Sham, 20 Hz TI Active, selected comparison frequency TI Sham, then selected comparison frequency TI Active. The comparison frequency will be in the 1-100 Hz range.
干预措施: Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI Active (Device)
dACC Comparison Frequency Sham then Active; 20Hz Sham then Active
Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using scalp electrodes. The stimulation order is: selected comparison frequency TI Sham, selected comparison frequency TI Active, 20 Hz TI Sham, then 20 Hz TI Active. The comparison frequency will be in the 1-100 Hz range.
干预措施: Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI Active (Device)
dACC Comparison Frequency Sham then Active; 20Hz Sham then Active
Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using scalp electrodes. The stimulation order is: selected comparison frequency TI Sham, selected comparison frequency TI Active, 20 Hz TI Sham, then 20 Hz TI Active. The comparison frequency will be in the 1-100 Hz range.
干预措施: Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Active (Device)
dACC Comparison Frequency Active then Sham; 20Hz Active then Sham
Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using scalp electrodes. The stimulation order is: selected comparison frequency TI Active, selected comparison frequency TI Sham, 20 Hz TI Active, then 20 Hz TI Sham. The comparison frequency will be in the 1-100 Hz range.
干预措施: Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Active (Device)
dACC 20Hz Active then Sham; Comparison frequency Active then Sham
Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using two pairs of carbon fiber electrodes in the following order: 20 Hz TI Active, 20 Hz TI Sham, selected comparison frequency TI Active, then selected comparison frequency TI Sham. The comparison frequency will be within the 1-100 Hz range.
干预措施: Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Active (Device)
dACC 20Hz Active then Sham; Comparison frequency Active then Sham
Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using two pairs of carbon fiber electrodes in the following order: 20 Hz TI Active, 20 Hz TI Sham, selected comparison frequency TI Active, then selected comparison frequency TI Sham. The comparison frequency will be within the 1-100 Hz range.
干预措施: Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Sham (Device)
dACC 20Hz Active then Sham; Comparison frequency Active then Sham
Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using two pairs of carbon fiber electrodes in the following order: 20 Hz TI Active, 20 Hz TI Sham, selected comparison frequency TI Active, then selected comparison frequency TI Sham. The comparison frequency will be within the 1-100 Hz range.
干预措施: Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI Active (Device)
dACC 20Hz Active then Sham; Comparison frequency Active then Sham
Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using two pairs of carbon fiber electrodes in the following order: 20 Hz TI Active, 20 Hz TI Sham, selected comparison frequency TI Active, then selected comparison frequency TI Sham. The comparison frequency will be within the 1-100 Hz range.
干预措施: Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI Sham (Device)
dACC Comparison Frequency Active then Sham; 20Hz Active then Sham
Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using scalp electrodes. The stimulation order is: selected comparison frequency TI Active, selected comparison frequency TI Sham, 20 Hz TI Active, then 20 Hz TI Sham. The comparison frequency will be in the 1-100 Hz range.
干预措施: Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI Active (Device)
dACC Comparison Frequency Active then Sham; 20Hz Active then Sham
Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using scalp electrodes. The stimulation order is: selected comparison frequency TI Active, selected comparison frequency TI Sham, 20 Hz TI Active, then 20 Hz TI Sham. The comparison frequency will be in the 1-100 Hz range.
干预措施: Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI Sham (Device)
研究者
Joshua Brown, PHD
Professor of Pyschological and Brain Science
Indiana University