Establishing Functional Biomarkers for Spaced Theta-Burst Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Changes in Motor Evoked Potential
研究概览
简要总结
The investigators plan to use functional magnetic resonance imaging (fMRI) methods to assess brain changes following spaced theta burst stimulation (TBS), a new form of repetitive transcranial magnetic stimulation (rTMS), in 10 healthy participants. The investigators will measure the effects of both excitatory (intermittent, iTBS) and inhibitory (continuous, cTBS) TBS applied to the motor cortex, a system that when stimulated produces a readily observable behavioral response (e.g., movement of a given body regions). In addition to brain activity, we will assess the effects of TBS on motor responses and pain perception. The goal is to determine how brain activity and blood flow during tasks and at rest change following the applications of spaced cTBS and iTBS. Additionally, the aim is to determine the duration of the spaced TBS effects on brain activity and behavior. This study will provide an understanding of the functional brain and behavioral changes that occur following spaced TBS to the motor cortex and has implications for reducing the long treatment schedules associated with classical rTMS protocols.
详细描述
Overall study design:
The investigators propose a functional MRI study of 10 healthy participants recruited from the community using a cross-over design over two days. On day 1, half of the participants will be randomized to receive iTBS and half will receive cTBS. On scan day 2 the alternate form of TBS will be applied such that all participants will have completed iTBS and cTBS sessions at the end of the two study days.
MRI scan days 1 and 2 will be identical except that iTBS will be applied on one day and cTBS on the other. The duration of the MRI scan session will be approximately 120 minutes each day. The iTBS and cTBS scans sessions will be separated by at least 3 days to ensure that the effects of scan day 1 are not carried over to scan day 2.
Each scan day will consist of the following sessions:
- Pre-scan session
- Baseline scan
- TBS (individually targeted to M1)
- Post-TBS scan
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 or older
- •Right-handed
- •Agree to having fMRI scan
- •Willingness to suspend use of analgesic drugs or cough suppressants for 24 hours prior to the scans
- •Proficiency in English sufficient to complete questionnaires/follow instructions during fMRI assessments
- •US Citizen or resident able to receive payment legally
排除标准
- •A medical condition that would contraindicate the use of rTMS
- •Any condition that would contraindicate MRI (like ferromagnetic metal in the body)
- •Pregnancy or breast feeding
- •Any significant neurologic disease, including dementia, multi-infarct dementia, Parkinson's or Huntington's disease, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, history of significant head trauma
- •Current antidepressant use (must be washed out for two weeks prior to starting protocol)
- •Inability to stop taking medication contraindicated with treatment
结局指标
主要结局
Changes in Motor Evoked Potential
时间窗: Prior to and and immediately after TBS sessions on each day (separated by 3+ days)
To determine the duration of effect of an application of a spaced TBS stimulation session (both inhibitory, cTBS and excitatory, iTBS) as measured by duration of change in motor evoked potential.
次要结局
- Changes in Arterial Perfusion(Prior to and and immediately after TBS sessions on each day (separated by 3+ days))
- Change From Baseline Motor Cortex Activity as Assessed by the BOLD Signal Immediately Post-TBS(Prior to and and immediately after TBS sessions on each day (separated by 3+ days))
- Change From Baseline Resting-state Functional Connectivity Between the M1 Hotspot and Other Motor Areas Immediately Post-TBS(Prior to and and immediately after TBS sessions on each day (separated by 3+ days))
研究者
Nolan R
Instructor of Psychiatry and Behavioral Sciences
Stanford University