Non-invasive Neurostimulation as a Tool for Diagnostics and Management for Neurodegenerative Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Changes in Rey Auditory Verbal Learning Test score
研究概览
简要总结
Double blinded, sham-controlled, randomized trial on repeated transcranial alternating current brain stimulation (tACS) in neurodegenerative diseases. The investigators will evaluate whether a 4-times daily repeated stimulation with gamma tACS on the posterior parietal cortex can improve symptoms in patients with neurodegenerative diseases, including dementia with Lewy Bodies, Alzheimer's disease, idiopathic normal pressure hydrocephalus and Frontotemporal dementia.
详细描述
Double blinded, sham-controlled, randomized trial on repeated transcranial alternating current brain stimulation (tACS) in neurodegenerative diseases. The investigators will evaluate whether a 4-times daily repeated stimulation with gamma tACS on the posterior parietal cortex can improve symptoms in patients with neurodegenerative diseases, including dementia with Lewy Bodies, Alzheimer's disease, idiopathic normal pressure hydrocephalus and Frontotemporal dementia.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild Cognitive Impairment due to Alzheimer's disease
- •Dementia with Lewy Bodies
- •Frontotemporal dementia
- •Idiopathic normal pressure hydrocephalus (iNPH)
排除标准
- •History of seizures
- •Pregnancy
- •Metal implants in the head (except dental fillings)
- •Electronic implants (i.e. pace-maker, implanted medical pump)
- •Age <18 years
结局指标
主要结局
Changes in Rey Auditory Verbal Learning Test score
时间窗: Baseline (immediately before the intervention), immediately after the first intervention, immediately after the 4th intervention, 4 weeks after the last intervention
Participants are given a list of 15 unrelated words repeated over five different trials and are asked to repeat. Another list of 15 unrelated words are given and the patient must again repeat the original list of 15 words and then again after 30 minutes. The examiner reads aloud 15 unrelated words and the participant is asked to recall the words after each of the five trials. After a 15 minute delay, the participant is asked again to recall the words. The score ranges from 0 (worst performance) to 75 (best performance).
Changes in Rey Auditory Verbal Learning Test, recognition
时间窗: Baseline (immediately before the intervention), immediately after the first intervention, immediately after the 4th intervention, 4 weeks after the last intervention
Participants are given a list of 15 unrelated words repeated over five different trials and are asked to repeat. After a 15 minute delay, the participant is asked to recognise the original 15 words intermixed with 31 distractor words. The score of the recognition part ranges from 0 (worst performance) to 46 (best performance).
Changes in orientation to time and place (MMSE questions 1-10)
时间窗: Baseline (immediately before the intervention), immediately after the last intervention, 4 weeks after the last intervention
10 questions about the orientation. The score ranges from 0 (worse performance) to 10 (best performance).
Changes in Trail Making A & B tests
时间窗: Baseline (immediately before the intervention), immediately after the 4th intervention, 4 weeks after the last intervention
TMT A \& B tests. Time to perform set is recorded.
Changes in INECO Frontal Screening test
时间窗: Baseline (immediately before the intervention), immediately after the 4th intervention, 4 weeks after the last intervention
Test battery assessing frontal lobe functions. The score ranges from 0 (worse performance) to 30 (best performance)
Changes in phonemic fluency
时间窗: Baseline (immediately before the intervention), immediately after the first intervention, immediately after the 4th intervention, 4 weeks after the last intervention
Person is requested to provide as many words as possible starting with certain letter. The score is the sum of all acceptable words produced in one minute.
次要结局
- Change in SAI measurements(Baseline (immediately before the intervention), immediately after the last intervention)
- Change in SICI measurements(Baseline (immediately before the intervention), immediately after the last intervention)
- Change in ICF measurements(Baseline (immediately before the intervention), immediately after the last intervention)
研究者
Eino Solje
MD PhD adj. prof.
Kuopio University Hospital