Effect of Transcranial Magnetic Stimulation as an Enhancer of a Cognitive Stimulation Maneuver in Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Montreal Cognitive Assessment (MoCA)
研究概览
简要总结
This study evaluates the effect of 5Hertz (Hz) repetitive Transcranial Magnetic Stimulation (rTMS) on Left Dorsolateral Prefrontal Cortex enhancing Cognitive Stimulation in Mild Cognitive Impairment.
详细描述
Mild Cognitive Impairment (MCI) is defined as an intermediate state between normal aging and an early stage of neurodegenerative diseases. It is estimated that exist 24.3 million people worldwide with neurocognitive disorders. Cognitive Stimulation (CS) is defined as the set of techniques and strategies that optimize the effectiveness in various functions of different cognitive abilities throughout its use in rehabilitation on MCI. Transcranial Magnetic Stimulation (rTMS) is a safe neuromodulation technique that modifies brain electrical activity through electromagnetic fields. There is evidence of the relationship between CS and rTMS for the improvement in MCI levels and cognitive functions; it´s important to deepen the knowledge of the therapeutic potential of both techniques combined on MCI
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Single
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of both genders.
- •Subjects from 60 to 85 years old.
- •Meet Diagnostic and Statistical Manual, 5th edition (DSM-5) diagnostic criteria for Mild Cognitive Impairment.
- •Patients must provide their oral and written informed consent.
排除标准
- •Subjects with history of traumatic brain injury with loss of consciousness.
- •Subjects with intracranial metallic objects or metal plates in the skull.
- •Subjects diagnosed with uncontrolled chronic (for example: hypertension, diabetes) or neurological diseases.
- •Comorbidity with other mental illness.
- •Presence of psychotic symptoms, Bipolar Disorder and Substance abuse.
- •Alterations in the electroencephalogram (epileptiform activity).
研究组 & 干预措施
5 Hz Stimulation
This group will receive 5Hz (Hertz) Left Dorsolateral Prefrontal Cortex repetitive Transcranial Magnetic Stimulation with 1500 pulses per session, three per weekday, with a final result of 30 sessions in this modality with a 30 minutes Cognitive Stimulation after session.
干预措施: Repetitive Transcranial Magnetic Stimulation (Device)
5 Hz Stimulation
This group will receive 5Hz (Hertz) Left Dorsolateral Prefrontal Cortex repetitive Transcranial Magnetic Stimulation with 1500 pulses per session, three per weekday, with a final result of 30 sessions in this modality with a 30 minutes Cognitive Stimulation after session.
干预措施: Cognitive Stimulation (Behavioral)
Placebo Stimulation
This group will receive the Sham modality simulating 1500 pulses of 5Hz Transcranial Magnetic Stimulation for 30 sessions, three per weekday with a 30 minutes Cognitive Stimulation afterwards.
干预措施: Repetitive Transcranial Magnetic Stimulation (Device)
Placebo Stimulation
This group will receive the Sham modality simulating 1500 pulses of 5Hz Transcranial Magnetic Stimulation for 30 sessions, three per weekday with a 30 minutes Cognitive Stimulation afterwards.
干预措施: Cognitive Stimulation (Behavioral)
结局指标
主要结局
Montreal Cognitive Assessment (MoCA)
时间窗: 24 weeks.
MoCA is a test that evaluates the presence of Mild Cognitive Impairment.
Attention and Memory Neuropsychological Battery (NEUROPSI)
时间窗: 24 weeks
NEUROPSI is a battery that evaluates the level of the Cognitive Impairment.
Mini Mental State Examination (MMSE)
时间窗: 24 weeks
MMSE is a test that seeks the presence of Mild Cognitive Impairment
次要结局
- Changes in impulsive behavior evaluated by Barratt Impulsivity Scale (BIS-11)(1 week)
- Changes in Depressive symptoms evaluated by Geriatric Depression Scale (GDS - Yesavage - Brink)(2 Weeks)
研究者
Dr. Julian Reyes López
Clinical Professor
Universidad Autonoma de Queretaro