Effect of Excitatory Theta-Burst Transcranial Magnetic Stimulation on Cognition in Patients With Both Parkinson's Disease and Mild Cognitive Impairment and Analysis of Functional and Structural Brain Changes After Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- TMS stimulation applied to the left DLPFC has a quantifiable effect on cognition
研究概览
简要总结
Parkinson's disease (PD) affects more than 100,000 Canadians and results in symptoms affecting both motor and cognitive (thinking and memory) functions. Parkinson's disease with Mild Cognitive Impairment (MCI) frequently results in development of dementia for which few treatment options exist. Transcranial Magnetic Stimulation (TMS) is used to alter activity in the outer regions of the brain and has been shown in previous studies to increase cognitive performance in patients with different disorders. This study will investigate the effectiveness of TMS as a clinical treatment for the cognitive deficits associated with Parkinson's disease. 64 male and female participants between the ages of 50 and 90 will attend eight study visits over a period of 63 to 66 days. This study is a double-blind randomized clinical trial meaning the participant will be assigned by chance to either the TMS-treatment group or the Sham-treatment group. Additionally, a combination of memory and thinking tests and Magnetic Resonance Imaging (MRI) will be used to see if there are structural and functional changes within the brain. Genotyping and blood analysis before and after treatment for different biomarkers will also be performed and these data will be compared to the TMS data. Initially, this research will increase knowledge about the effects of TMS on various brain regions. Ultimately, we will be able to determine if TMS can be used as a complementary therapy for PD to improve cognitive performance and to reduce progression into dementia.
详细描述
Visit 1:
Informed Consent Neuropsychological Battery
Visit 2: (1-2 days later) Blood Draw Neuropsychiatric Assessment Questionnaires Companion Questionnaire to take home UPDRS
Visit 3: (up to a week after visit 2) MRI Scan while performing Executive Task
Visit 4: (1-3 days after visit 3) TMS- or Sham-Treatment (two sessions , 20 min each, 1 hour apart)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The participant and investigator do not know what treatment is applied (TMS stimulation or Sham-TMS stimulation with a different coil).
The outcomes assessor will also be blinded.
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic Parkinson's disease any stage
- •Mild Cognitive Behaviour confirmed through neuropsychological assessment
- •MRI Compatibility
排除标准
- •Alcohol-dependency
- •Severe psychiatric disorder, neurological disorder, epilepsy or stroke
- •General anaesthesia in the past six months
- •History of cerebrovascular disorders
- •Colour-blindness
结局指标
主要结局
TMS stimulation applied to the left DLPFC has a quantifiable effect on cognition
时间窗: Neuropsychological Assessments: Baseline, one day after and one month after TMS stimulation
Changes in one or more of the five assessed brain domains at baseline and one day after stimulation will be measured by comparing the scores for the different neuropsychological tests. The same neuropsychological assessment one month after TMS stimulation will show, if possible changes from one day after are longer lasting and can still be seen.
次要结局
- Change in structural grey and white matter in the brain at baseline compared to after TMS stimulation(MRI: Baseline and two days after TMS stimulation)
- Change in executive functioning measured as BOLD fMRI sequence(MRI: Baseline and two days after TMS stimulation)
- Change in levels of biomarkers of interest (alpha-synuclein and BDNF) in serum after TMS stimulation compared to baseline.(Blood draws: Baseline and two days after TMS stimulation)
- Genotyping(Blood draw for DNA analysis: Baseline)
研究者
Oury Monchi
Professor and Tourmaline Chair in Parkinson's Disease
University of Calgary