跳至主要内容
临床试验/CTRI/2020/12/029965
CTRI/2020/12/029965尚未招募不适用

Investigating the role of nicotinic neuromodulation in levodopa-induced dyskinesias – a multimodal study.

National Brain Research Centre1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2021年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
76
试验地点
1
主要终点
Motor cortical inhibition, Motor cortical plasticity

研究概览

简要总结

Parkinson’sdisease is a progressive neurodegenerative disease characterized mainly byinvoluntary movements in the form of tremors, rigidity, bradykinesia andpostural instability. As of now, there is no permanent cure to this conditiondescribed in the medical literature till date. Even the most effective medication available today (levodopa) can havevery disabling side effects. Many patients receiving treatment for Parkinson’sdisease experience abnormal involuntary movements (levodopa-induced dyskinesias, LID), which isone of the major side effects of the medication they take. In this study, we willinvestigate the cause of such abnormal involuntary movements that occur inParkinson’s disease patients during the course of the treatment. We want tounderstand why this side effect occurs and if nicotine can be used to preventits occurrence or reduce its severity.Wewill determine the structural and functional changes in the brain caused bynicotine skin patch using several non-invasive methods such as transcranialmagnetic stimulation, electroencephalography, and magnetic resonance imagingand correlate them with clinical and behavioral measures. We expect that theresults of this study will help us to understand the disease better and improvecurrent treatment options.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
30.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • non-smoker (>10 years).
  • able to provide informed consent.

排除标准

  • The subjects may not be eligible to participate if he/she.
  • Has any neurological disorder (except PD in the patient group) -Has a current depressive episode, schizophrenia or bipolar disorder (self-declared and screened with GHQ-12 (Goldberg et al., 1978; Qin et al., 2018)) -Has had any head injury with loss of consciousness.
  • Has had any seizures in the past -Has cognitive impairment (Mini Mental Status Examination (MMSE) test score<25) -Abuses drugs/alcohol -Is pregnant or nursing Subjects will not be eligible for MRI scanning if they.
  • Have non-MRI compatible metal in the body such as a cardiac pacemaker, brain stimulator, surgical metal, cochlear implants, artificial heart valves or dental implants. -Are unable to lie flat on the back for the duration of the scan. -Have uncontrollable head movements. -Are claustrophobic. Subjects will not be eligible to undergo TMS if they – -Have metal implants in the body such as brain stimulator, surgical metal, cochlear implants, cardiac pacemaker, intracardiac lines, implanted pumps or stimulators.

结局指标

主要结局

Motor cortical inhibition, Motor cortical plasticity

时间窗: baseline, 4 hours after patch, 1 hour after levodopa medication

次要结局

  • cortical connectivity(cortical reactivity)

研究者

发起方
National Brain Research Centre
申办方类型
Research institution

研究点 (1)

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