Effect of High Frequency/Low Intensity Transcranial Magnetic Stimulation in Cognitive Traits of an Elderly Population of Subjects With Mild Cognitive Impairment and Mild Dementia: A Randomized, Double Blind, Parallel Group, Sham Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Proportion of patients suffering any kind of adverse effect
研究概览
简要总结
There are no pharmacological interventions that delay or prevent the transition of mild cognitive impairment to dementia. Several studies have shown that transcranial magnetic stimulation (TMS) could be useful in increasing cognitive traits in dementia.
As TMS is performed in a clinical setting, transportation, mobility and high costs of treatment, limit the number of TMS sessions dementia patients can receive. Most of the trials do not apply more than 20 TMS sessions
Here, a randomized, sham controlled, paralallel group, clinical trial will be performed in order to asess the efficacy at improving cognitive traits of a novel TMS device that uses high frequency and low intensity pulses. As the device is portable and can be used from home without clinical supervision, the stimulation will be applied two times per day for a period of 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IInclusion Criteria:
- •( - ) CDR less or equal to 1 ( - ) Mild cognitive impairment by Petersen criteria ( - ) Conserved or corrected sight ( - ) Enrolled at INCMNSZ for medical care ( - ) Be able to read and write ( - ) Willing and able to provide written informed consent
排除标准
- •( - ) Other neurodegenerative disorder different than mild cognitive impairment or mild dementia ( - ) Metabolic disease without medical care ( - ) Epilepsy ( - ) Deep brain stimulator ( - ) Metalic prosthethics in the skulls ( - ) Major depressive disorder ( - ) Previous utilization of other neuromodulation technique ( - ) Signs or symptoms of increased intracraneal pressure
结局指标
主要结局
Proportion of patients suffering any kind of adverse effect
时间窗: 6 months
次要结局
- Change from baseline of total Katz Index of Independence in Activities of Daily Living at 3 months(3 months)
- Change from baseline of total Katz Index of Independence in Activities of Daily Living at 6 months(6 months)
- Change from baseline of total Lawton Instrumental Activities of Daily Living Scale at 3 months(3 months)
- Change from baseline of total Lawton Instrumental Activities of Daily Living Scale at 6 months(6 months)
- Change from baseline of total Geriatric Depression Scale at 3 months(3 months)
- Change from baseline of total Geriatric Depression Scale at 6 months(6 months)
- Change from baseline of total Montreal Cognitive Assessment at 3 months(3 months)
- Change from baseline of total Montreal Cognitive Assessment at 6 monts(6 months)
- Change from baseline of total Frontal Asessment Battery at 3 monts(3 months)
- Change from baseline Frontal Asessment Battery at 6 monts(6 months)
- Change from baseline ADAS-COG at 6 monts(6 months)
研究者
Alberto José Mimenza Alvarado
Principal Investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran