Repetitive Transcranial Magnetic Stimulation for Apathy Clinical Trial (REACT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Neuropsychiatric Inventory-apathy
研究概览
简要总结
Apathy is a common, early, and disabling symptom in dementias and mild behavioural impairment such as Alzheimer's disease (AD) and is characterized by lack of interest and enthusiasm. Both repetitive transcranial magnetic stimulation (rTMS), a form of non-invasive brain stimulation, and methylphenidate, a medication, have been shown to improve apathy. This pilot study will investigate rTMS as a treatment for apathy in neurocognitive disorders and mild behavioural impairment in individuals receiving methylphenidate and individuals not receiving medication for apathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mild or major neurocognitive disorder OR mild behavioural impairment
- •Apathy for at least 4 weeks
- •Stable dose of medication (>4 weeks) that may affect cognition or behaviour
- •Care partner who spends at least 10 hours a week with the subject
排除标准
- •Current major depressive episode
- •Agitation, delusions, hallucination
- •Medical contraindications to rTMS
- •Currently taking an amphetamine product
- •Central nervous system abnormalities, Tourette's syndrome, or motor tics
- •Current participation in another clinical trial
研究组 & 干预措施
rTMS + methylphenidate
repetitive transcranial magnetic stimulation (rTMS) and methylphenidate
干预措施: methylphenidate (Drug)
rTMS + methylphenidate
repetitive transcranial magnetic stimulation (rTMS) and methylphenidate
干预措施: rTMS (Device)
rTMS only
repetitive transcranial magnetic stimulation (rTMS) only
干预措施: rTMS (Device)
结局指标
主要结局
Neuropsychiatric Inventory-apathy
时间窗: 2 weeks
Measure of apathy on a scale from 0 to 12 with a higher score indicating greater apathy
次要结局
未报告次要终点