Repetitive Transcranial Magnetic Stimulation for Apathy in Alzheimer's Dementia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Apathy Evaluation Scale (AES)
研究概览
简要总结
Alzheimer's Dementia (AD) is a major public health problem. Apathy, a profound loss of motivation, is seen in majority of patients with AD. Dysfunction of the front of the brain and loss of dopamine, a type of neurochemical, in this part of brain results in apathy. Presence of apathy is linked to deficits in planning sequential tasks such as keeping a routine. Patients with apathy have poor physical function and their caregivers experience extra burden. Unfortunately there are no good medications to treat apathy. FDA has approved the use of brain stimulation by a magnet known as repetitive transcranial magnetic stimulation (rTMS), for treatment of depression. rTMS increases dopamine when applied to frontal lobe of brain so we propose that rTMS would be a good treatment option for apathy in AD. Study hypotheses include that rTMS to the dorsolateral prefrontal cortex (DLPFC) will improve apathy and executive function better than sham treatment in those with AD.
详细描述
Objective
Alzheimer's Dementia (AD) is a major public health problem. Apathy, a profound loss of motivation, is seen in majority of patients with AD. Dysfunction of the front of the brain and loss of dopamine, a type of neurochemical, in this part of brain results in apathy. Presence of apathy is linked to deficits in planning sequential tasks such as keeping a routine. Patients with apathy have poor physical function and their caregivers experience extra burden. Unfortunately there are no good medications to treat apathy. FDA has approved the use of brain stimulation by a magnet known as repetitive transcranial magnetic stimulation (rTMS), for treatment of depression. rTMS increases dopamine when applied to frontal lobe of brain so we propose that rTMS would be a good treatment option for apathy in AD.
Specific Aims: To determine the efficacy of rTMS to the dorsolateral prefrontal cortex (DLPFC) in treating apathy in mild AD in comparison to sham treatment.
• To compare the efficacy of rTMS to the DLPFC on executive function in mild AD in comparison to sham treatment.
Research Plan: Current study is a prospective randomized sham controlled study of daily rTMS.
Methods: Up to 500 subjects will be pre-screened to enroll 100 subjects for screening and randomizing up to 50 subjects to analyze 20 completers. Subjects with mild AD and apathy will be randomly assigned to rTMS or sham treatment after consent. All subjects will be tested for memory, behavioral problems, functioning and caregiver burden. Apathy will be assessed using the Apathy Evaluation Scale. Memory, executive function, functional status and caregiver burden will be assessed. Subjects will receive daily treatments for 4 weeks with either rTMS or sham coil for a total of 20 treatments. Neither the subject nor the investigators will know which treatment the subject is receiving. Testing will be repeated at the end of 4 weeks and at 8 and 12 weeks 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 91 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects age ≥ 55 years,
- •Diagnosis of Alzheimer's dementia meeting the DSM-IV TR criteria,
- •Apathy Evaluation Scale-Clinician (AES-C) score of ≥ 30,
- •Mini Mental Status Examination (MMSE) ≥ 18,
- •Subjects who clear the TMS adult safety scale (TASS)
- •On stable dose of antidepressants or dementia medicines (if applicable) for at least two months
排除标准
- •Subjects taking medications known to increase the risk of seizures from the 2012 Beers criteria: Bupropion, chlorpromazine, clozapine, maprotiline, olanzapine, thioridazine, thiothixene, and tramadol.
- •Subjects taking medications known to increase seizure threshold not listed in the Beers criteria but in the opinion of PI increase seizure threshold: tricyclic antidepressants, theophylline, methylphenidate, and high-dose thyroid supplementation.
- •Subjects taking ototoxic medications: Aminoglycosides, Cisplatin.
- •Subjects in current episode of major depression
- •History of bipolar disorder
- •Subjects with history of seizure or first degree relative with seizure disorder
- •Subjects with implanted device: wearable or implantable cardioverter defibrillators, conductive, ferromagnetic, or other magnetic sensitive metals that are implanted or are non-removable within 30 cm of the treatment coil or those with cochlear implants
- •Subjects with diagnosis of current alcohol related problems
- •Subjects with history of stroke , aneurysm, or cranial neurosurgery
- •Any condition that in the opinion of the study physician is likely to compromise their ability to safely participate in the study
结局指标
主要结局
Apathy Evaluation Scale (AES)
时间窗: 4 weeks
AES is an 18-item scale that assesses apathy in behavioral, cognitive and emotional domains over the previous four weeks.
次要结局
- Trials making test(4 weeks)
研究者
Prasad R. Padala
Associate Director for clinical programs, GRECC
Central Arkansas Veterans Healthcare System