Repetitive Transcranial Magnetic Stimulation for Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Changes From Baseline CVLT Scores After Treatment and 4 Month Later
研究概览
简要总结
The purpose is to is to study if repetitive transcranial magnetic stimulation (rTMS) improves cognitive function in patients with neurodegenerative conditions which may manifest as mild to moderate cognitive impairment and, in late phase, dementia. This study also intends to investigate if the responses to rTMS intervention are either positively or negatively correlated with the initial severity of cognitive impairment.
详细描述
The primary hypothesis is that rTMS applied to the dorsolateral prefrontal cortex will lead to improved memory, language and executive function compared to patients who receive a sham, control treatment. The improvement is defined as having higher performance on the California Verbal Learning Test (CVLT-II). Secondary Hypotheses are that:
- 1: rTMS- will lead to higher performance on secondary cognitive measures relating to executive function and naming compared to performance by participants in the sham treatment group at the termination of treatment; and that
- 2: rTMS-induced memory improvement parallels changes in serum and cerebrospinal fluid (CSF) brain-derived neurotrophic factor (BDNF) levels after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veterans aged 55 years or older
- •Diagnosed with Mild Cognitive Impairment (MCI) or dementia likely due to Alzheimer's disease.
- •Ability to obtain a Motor Threshold, determined during the screening process.
- •With an adequately stable condition and living environment to enable attendance at scheduled clinic visits.
- •If on a prescription medication for cognition that medication dose will be stable for at least 4 weeks prior to randomization into the study and participant will be willing to remain on a stable regimen during the acute treatment phase.
- •Able to read, verbalize understanding, and voluntarily sign the Informed Consent Form to be signed by the participant, or a designated legal representative when the participant lacks decision making capacity prior to participating in any study- specific procedures or assessments.
排除标准
- •Patients with prior exposure to rTMS or electroconvulsive therapy (ECT).
- •Unable to safely withdraw, at least two weeks prior to treatment commencement, from medications that substantially increase the risk of having seizures.
- •Have a cardiac pacemaker or a cochlear implant.
- •Have an implanted device deep brain stimulation or metal in the brain
- •Current substance abuse not including caffeine or nicotine as determined by patient report or chart review.
- •Active current suicidal intent or plan as determined by patient report or chart review.
- •Current or Prior history of a seizure disorder as determined by patient report or chart review
- •Traumatic brain injury within the last two months
- •Participation in another concurrent interventional clinical trial
- •Known current psychosis as determined by patient report or chart review.
- •Current or prior history of a mass lesion, cerebral infarct or other non-cognitive, active central nervous system (CNS) disease that would increase the risk for seizure.
- •Not fluent in English or a hearing impairment severe enough to impair comprehension
结局指标
主要结局
Changes From Baseline CVLT Scores After Treatment and 4 Month Later
时间窗: Assessed at baseline, end of treatment, and 4-month post-treatment follow up
Changes of California verbal learning test scores (CVLT) from baseline after treatment and 4 months later. CVLT is 16 points scoring system. (minimum=0, maximum=16, higher the better memory).
次要结局
- Changes in Boston Naming After Treatment(Assessed at baseline, end of treatment, and 4-month post-treatment follow up)
- Changes in Plasma BDNF Levels After Treatment(within a week following the last treatment session and 4 months later)
- Changes in Animal Fluency After Treatment and 4 Months Later(Assessed at baseline, end of treatment, and 4-month post-treatment follow up)
- Changes in Trail Making B Test Score After Treatment and 4 Months Later(Assessed at baseline, end of treatment, and 4-month post-treatment follow up)
- Montreal Cognitive Assessment (MoCA)(Assessed at baseline, end of treatment, and 4-month post-treatment follow up)
- Brief Visual Memory Test (BVMT)(assessed at baseline, end of treatment and 4-month post-treatment follow up)