A Randomized Controlled Pilot Study of TMS Enhancement of Associative Memory Networks in Healthy Subjects and Epilepsy Patients
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
- Mean Change in Face-Object Pair Association Task Score During Motor Cortex Stimulation
研究概览
简要总结
This is a randomized, single-blinded, controlled phase 1 study to demonstrate feasibility and explore the neurophysiologic and clinical effects of repetitive transcranial magnetic stimulation (TMS) interventions in epilepsy patients and healthy controls. The inclusion of a control group will be used to see whether epilepsy patients, who suffer from a higher degree of comorbid memory difficulty presumably from entorhinal-hippocampal dysfunction, can benefit from a TMS intervention can benefit as much as a healthy matched population. Investigators will also be looking at functional connectivity between the hippocampus and cortical regions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fluent in English
- •Right-handed
- •Score at least 26 out of 30 on the Montreal Cognitive Assessment (MOCA). Healthy subjects will be matched to age, handedness, and education compared to epilepsy subjects.
- •Must be able to provide informed consent.
排除标准
- •Any history of a neurological disorder
- •Chronic or progressive medical condition
- •Any history of severe traumatic brain injury or skull defect
- •Metal or devices in the head, including neurostimulators of metal foreign bodies
- •Any other implanted metal device, including pacemaker, spinal cord stimulator, VNS.
- •Any other ferromagnetic substance in the body (including tattoos, dental prosthetics, etc).
- •Taking a medication which may lower the seizure threshold within the 4 weeks prior to the start of the study, including use of neuroleptic (esp. clozapine), antibiotic (penicillin, cephalosporins), and bronchodilating medications.
- •Pregnancy
研究组 & 干预措施
Healthy Subjects
干预措施: MagStim RapidStim2 (Diagnostic Test)
Temporal Lobe Epilepsy Patients
干预措施: MagStim RapidStim2 (Diagnostic Test)
结局指标
主要结局
Mean Change in Face-Object Pair Association Task Score During Motor Cortex Stimulation
时间窗: Immediately before Motor Cortex Stimulation, Immediately after Motor Cortex Stimulation (20 minute procedure; Up to Week 6)
A face-object pair association task will be administered before and after rTMS treatment at each treatment session. This measure is evaluating the mean change in the task score from immediately before rTMS is applied to the motor cortex to immediately after treatment.
Mean Change in Face-Object Pair Association Task Score During Left Lateral Parietal Site Stimulation
时间窗: Immediately before Left Lateral Parietal Site Stimulation, Immediately after Left Lateral Parietal Site Stimulation (20 minute procedure; Up to Week 6)
A face-object pair association task will be administered before and after rTMS treatment at each treatment session. This measure is evaluating the mean change in the task score from immediately before rTMS is applied to the left lateral parietal site to immediately after treatment.
次要结局
- Mean Change in Word-Pair Association Task Score During Left Lateral Parietal Site Stimulation(Immediately before Left Lateral Parietal Site Stimulation, Immediately after Left Lateral Parietal Site Stimulation (20 minute procedure; Up to Week 6))
- Change in fMRI-based Functional Connectivity Between Hippocampus and Cortical Regions(Baseline, Week 6)
- Mean Change in Word-Pair Association Task Score During Motor Cortex Stimulation(Immediately before Motor Cortex Stimulation, Immediately after Motor Cortex Stimulation (20 minute procedure; Up to Week 6))