Effect of Transcutaneous Electrical Nerve Stimulation on Cognitive Disorders in Multiple Sclerosis Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- change in the level of cognition measured by Addenbrooke's cognitive examination
研究概览
简要总结
The aim of this study is to evaluate whether the Transcutaneous Electrical Nerve Stimulation (TENS) is effective on improvement of cognitive disorders in Multiple sclerosis patients.
详细描述
Multiple sclerosis (MS) is one of the most common autoimmune diseases in the world. One of the complications of MS, is cognitive disorder.
In some studies on rats, stimulation of somatosensory neurons has improved the hippocampus activity by increasing the amount of acetylcholine. Hippocampus has a major role in cognition and behavior.
TENS is a non-invasive method in which the electrical pulses are sent to the body trough skin by electrodes. This device can stimulate the somatosensory neurons by electrical impulses. In several studies, the effect of TENS has been proved on short term memory and verbal fluency in patients with mild stages of Alzheimer disease. Also it has been effective on some aspects of cognition on old people suffering from forgetfulness.
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
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with confirmed multiple sclerosis by McDonald criteria;
- •score 25 or less in mini mental state examination (MMSE)
排除标准
- •MMSE score greater than 25;
- •the history of psychiatric problems;
- •addiction to alcohol; head trauma; cerebrovascular disease; hydrocephalus; neoplasm; epilepsy; renal or respiratory diseases; impaired consciousness
结局指标
主要结局
change in the level of cognition measured by Addenbrooke's cognitive examination
时间窗: 6 weeks
Addenbrooke's cognitive examination has 100 parts and measures different aspects of cognition including memory, concentration, language, verbal fluency and visuospatial skills. The patients will take the test before and after using the TENS device
次要结局
未报告次要终点
研究者
Leila Dehghani
assistant prof
Isfahan University of Medical Sciences