Safety and Efficacy of an Accelerated Protocol of Intermittent Theta Burst Transcranial Magnetic Stimulation (TMS) to Enhance Performance and Promote Resilience in Astronauts: Study 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Mean Score of Neurocognitive Performance (Fluid Cognition)
研究概览
简要总结
The purpose of this study is to determine the most effective dose of brief, non-invasive brain stimulation (repetitive transcranial magnetic stimulation, rTMS) for improving cognitive functions such as attention and memory as well as to improve the ability to recover from stressful situations (stress resilience).
详细描述
Repetitive transcranial magnetic stimulation (rTMS) works by rapidly turning a focused magnetic field on-and-off repeatedly over your head, which passes directly through your hair, scalp, and skull and onto your brain, and can temporarily increase brain activity under the magnetic field. Repetitive transcranial magnetic stimulation (rTMS) is an FDA approved treatment for depression, and is used commonly to treat people for their depression. The rTMS treatment regime used in this study is different from the FDA approved treatment because you will receive up to ten treatments per day over five days instead of the FDA approved rTMS treatment regime of 25 treatments over 25 days. This sort of accelerated or high dose protocol has been shown to be safe and effective in the treatment of depression. We are hoping to find out if this treatment can be used as a treatment for improving cognitive function and stress resilience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 22 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No history of mental or physical illness
- •No implanted metal in the body
- •College graduates (Associates degree or higher)
- •Negative urine pregnancy test, if female subject of childbearing potential
- •Able to read and understand questionnaires and informed consent
排除标准
- •Any current psychiatric diagnosis or current Clinical Global Impression ratings of psychiatric illness > 1
- •Current physical illness
- •History of CNS disease, concussion, overnight hospitalization, tumors, seizures, meningitis, encephalitis, abnormal CT/MRI of the brain
- •Moderate to severe traumatic brain injury (TBI)
- •History of a continuing significant laboratory finding
- •Frequent or severe headaches
- •Any history of psychotropic medication prior to study enrollment
- •Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.
- •active participation or plan for enrollment in another evidence-based clinical trial affecting psychosocial function
- •repeated abuse or dependence upon drugs (excluding nicotine and caffeine)
- •implanted devices/ferrous metal of any kind
结局指标
主要结局
Mean Score of Neurocognitive Performance (Fluid Cognition)
时间窗: Baseline (Day 1)
Participants would complete a computerized batteries (Penn Computerized Neuropsychological Battery and NIH Cognition Battery). Tasks would assess the following domains: information-processing speed, executive function, sustained attention/vigilance, verbal memory, working-memory capacity, inhibition/impulsivity, and sensorimotor function. This composite includes all the tests noted above that are fluid ability measures: Flanker, Dimensional Change Card Sort, Picture Sequence Memory, List Sorting and Pattern Comparison. This composite score is derived by averaging the standard scores of each of the measures, and then deriving standard scores based on this new distribution. Higher values (positive changes from baseline) indicate better performance. The T-score has a mean of 50 in the general population and a SD of 10. Scores higher than the mean indicate better performance.
Change From Baseline in Neurocognitive Performance at 1 Week Post Treatment (Fluid Cognition)
时间窗: Post-treatment (within 1 week of completing rTMS)
Participants would complete a computerized batteries (Penn Computerized Neuropsychological Battery and NIH Cognition Battery). Tasks would assess the following domains: information-processing speed, executive function, sustained attention/vigilance, verbal memory, working-memory capacity, inhibition/impulsivity, and sensorimotor function. This composite includes all the tests noted above that are fluid ability measures: Flanker, Dimensional Change Card Sort, Picture Sequence Memory, List Sorting and Pattern Comparison. This composite score is derived by averaging the standard scores of each of the measures, and then deriving standard scores based on this new distribution. The T-score has a mean of 50 in the general population and a SD of 10. Scores higher than the mean indicate better performance.
Change From Baseline in Neurocognitive Performance at 1 Month Post Treatment (Fluid Cognition)
时间窗: Post-treatment (within 1 month of completing rTMS)
Participants would complete a computerized batteries (Penn Computerized Neuropsychological Battery and NIH Cognition Battery). Tasks would assess the following domains: information-processing speed, executive function, sustained attention/vigilance, verbal memory, working-memory capacity, inhibition/impulsivity, and sensorimotor function. This composite includes all the tests noted above that are fluid ability measures: Flanker, Dimensional Change Card Sort, Picture Sequence Memory, List Sorting and Pattern Comparison. This composite score is derived by averaging the standard scores of each of the measures, and then deriving standard scores based on this new distribution. The T-score has a mean of 50 in the general population and a SD of 10. Scores higher than the mean indicate better performance.
次要结局
- Mean Score of Stress Resilience as Assessed by Connor Davidson Resilience Scale(Post-treatment (within 1 month of completing rTMS))
- Mean Score of Stress Resilience as Assessed by Perceived Stress Scale-10(Post-treatment (within 1 month of completing rTMS))
- Mean Score of Stress Resilience as Assessed by Inventory of Depression and Anxiety Symptoms-II(Post-treatment (within 1 month of completing rTMS))
- Mean Score of Neurocognitive Performance (WINSCAT Composite)(Post-treatment (within 1 month of completing rTMS))
- Mean Score of Neurocognitive Performance (Stress Total Score)(Post-treatment (within 1 month of completing rTMS))