Effect of Non-invasive Vagus Nerve Stimulation on Cognitive Functions in Diabetic Polyneuropathy Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Attention/ concentration score
研究概览
简要总结
Diabetic peripheral neuropathy (DPN) occurs due to long standing hyperglycemia and associated metabolic derangements. Cognitive impairment is a common complication in diabetes mellitus. It is associated with a faster rate of cognitive decline.
详细描述
This research aims to
- determine the effect of non-invasive Vagus nerve stimulation on cognitive functions in diabetic peripheral neuropathy.
- investigate the correlation between cognitive function and severity of diabetic neuropathy.
- investigate the correlation between cognitive function and quality of life in diabetic peripheral neuropathy.
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients with diabetic polyneuropathy
- •Female patients.
- •age ranges from 40 to 55 years old.
- •Duration of diabetic illness started since at least three years.
- •Patients with mild to moderate neuropathy according to Toronto clinical neuropathy score
- •Patients with cognitive function ranges from 24 - 15 score according to Mini mental state examination
- •Patients with HbA1c ranges from seven to nine score.
- •Ambulant patients with or without walking aids.
- •Medically and psychologically stable patients without cardiac problems, confirmed by Electro Cardiogram (ECG).
- •able to understand instructions.
排除标准
- •Type I diabetes mellitus.
- •Severe visual, verbal or acoustic impairments.
- •Sever cognitive dysfunctions or that caused by other cause rather than diabetes mellitus.
- •Polyneuropathy caused by other cause rather than diabetes mellitus.
- •Other neurological problem as stroke.
- •Cardiovascular problems.
- •Metallic implants
- •Illiterate patients.
- •Uncooperative patients.
结局指标
主要结局
Attention/ concentration score
时间窗: post intervention (after one month)
Rehacom will be used to assess score of attention/ concentration domain of cognitive function
Executive function score
时间窗: at baseline
Rehacom will be used to assess score of executive function domain of cognitive function
working memory score
时间窗: post intervention (after one month)
Rehacom will be used to assess score of working memory domain of cognitive function
Executive function
时间窗: post intervention (after one month)
Rehacom will be used to assess score of executive function domain of cognitive function
次要结局
未报告次要终点
研究者
heba ahmed khalifa
Ass. Prof. Dr of Physical therapy for Neurology
Cairo University