The Development and Human Translation of Temporal Interference Brain Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Participants With a Change in Their Visual Field
研究概览
简要总结
The primary aim of this study is to translate temporal interference (TI) stimulation methodology into humans and examine its safety, feasibility, steerability, and focality. In the proposed early phase human experiment, the ability to apply TI stimulation will be assessed along spatial dimensions to selectively modulate neural activity and assess the feasibility of selective targeting deep brain structures without exciting overlaying cortex. The overall goal of the study is to advance TI methodology and its translation to humans.
The specific aims in this study are to
- Assess the safety of TI stimulation.
- Assess the feasibility, focality, and steerability of TI stimulation by selectively modulating activity in subregions of a cortical area (calcarine cortex)
It is hypothesized that TI stimulation can be used to impact different regions of the visual field that are represented within the calcarine fissure of the human brain.
It is hypothesized that TI will be well tolerated by human subjects and side effects will be consistent with other forms of transcranial electric current stimulation (tES).
详细描述
This is an investigational early phase testing of temporal interference (TI) stimulation in humans. The overall aim of the study is to assess the safety, feasibility, focality, and steerability of TI stimulation by selectively modulating activity in subregions of a cortical area (calcarine cortex - the primary visual cortex)
Healthy subjects who meet inclusion and exclusion criteria will be entered into the study. The study will recruit up to 20 subjects with the aim to complete 12 subjects.
Study Visits:
The study will consist of up to 6 study visits. The screening and baseline visit, the MRI visit, and up to 4 TI study. The screening and baseline visit and TI visits will occur at Beth Israel Deaconess Medical Center in the Berenson-Allen Center. The MRI visit will take place at the Boston University Cognitive Neuroimaging Center. After Informed Consent is obtained, the following screening and baseline procedures will be completed:
- Inclusion and exclusion criteria review
- Subject demographics
- Handedness assessment
- Medical history and medication review
- Physical and Neurological exam conducted by a Neurologist or Neurologic Nurse Practitioner
- Baseline perimetry assessment
- Baseline EEG
- The Mini International Neuropsychiatric Interview (MINI) assessment
- All female subjects will undergo a pregnancy test and pregnant women will be excluded
- Screening for retinotopic mapping - assessing the participant's ability to hold fixation with their eyes for experimental trials
- MRI safety review
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal healthy volunteer
- •18-35 years of age
- •Normal vision
- •Right handed
排除标准
- •Corrected-to-Normal vision, or visual impairment.
- •Any current or past history of a psychiatric disorder
- •Any current or past history of neurological disorders or acquired neurological disease (e.g. stroke, traumatic brain injury), including intracranial lesions
- •History of head trauma resulting in prolonged loss of consciousness; or a history of >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 elsewhere unless approved by the responsible MD
- •Any medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagal nerve stimulator) unless otherwise approved by the responsible MD
- •Substance abuse or dependence within the past six months
- •Pregnancy; all female participants of child bearing age will be required to have a pregnancy test; any participant who is pregnant will not be enrolled in the study.
- •Not on any medications with the exception of birth control unless approved by the responsible MD.
研究组 & 干预措施
Temporal Interference (TI) Stimulation
Temporal Interference stimulation applied to the head via standard electrodes
干预措施: Temporal Interference (TI) Stimulation (Device)
结局指标
主要结局
Participants With a Change in Their Visual Field
时间窗: Immediately after intervention
Number of participants who had a change in their visual field (scitoma) as assessed by a neurophthalmologist.
次要结局
未报告次要终点
研究者
Daniel Press
Associate Professor of Neurology
Beth Israel Deaconess Medical Center