Investigation of the Benefits of Electrical Non-invasive Stimulation on Cognitive Symptoms in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Difference in cognitive performance measured by the stop signal reaction time (SSRT) compared between real and sham stimulation conditions
研究概览
简要总结
Parkinson's disease is the second most common neurodegenerative disease after Alzheimer's disease.
It is mostly characterized by the presence of motor difficulties. However, it can also be accompanied by cognitive disorders which have an equally significant impact on the quality of life of patients and which are not relieved by any treatment.
Among the functions affected by Parkinson's disease, inhibition is an essential process for adapting our behaviors in daily life. Inhibition allows us to stop an action that is no longer required or appropriate to the situation in which we find ourselves in. For example, it comes into play when we have to stop at a "stop" sign while driving.
Recent studies suggest that it could be possible to improve the functioning of these processes by using non-invasive brain stimulation tools. Transcranial alternating current electrical stimulation has thus showed promising results in improving functions such as working memory. This technique is completely painless and non-invasive and consists in applying an electric current of very low intensity (barely perceptible) at the level of the scalp, using electrodes.
The investigators are conducting a study to test whether transcranial alternating current electrical stimulation could improve the functioning of the inhibition process which is altered in patients. For this, the investigators will measure this process using a task performed on a computer (the Stop Signal Reaction Time Task), as well as brain activity using a method called "electroencephalography", before and after stimulation. For this study, the investigators will include 50 patients and 40 healthy participants to investigate the effect of the stimulation on inhibition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
盲法说明
Sham and real tACS will be applied with the same equipment (StarStim, Neuroelectrics). The stimulation will consist in applying a current (max 2 mA) at frontal sites (F8 and Cz) for 12-15 minutes during the task. A 10 s ramp (fade-in/fade-out) will be used to avoid current perception of the stimulation and optimize blinding. Sham stimulation will be done using the same protocol, but with no stimulation in between onset and offset. According to the most recent literature (Russo et al., 2013), tACS does not usually cause other sensations, allowing to distinguish it from sham. EEGs will be performed with the same chronology and monitoring. As a whole V2 and V3 will consist of this pattern : task+EEG before stimulation, then task+stimulation, then task+EEG. Blinding of the experimenter will be made possible because it is the PI who will start the stimulation program and he will not be involved in the analysis of the raw data and a random number will be given to the participant.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For all participants:
- •Affiliation to a social security scheme or beneficiary of such a scheme.
- •Age over 18 years old.
- •Age less than 75 years old
- •Correct or correctly corrected view (on simple declaration by the patient).
- •Subject having received information on the protocol and having provided informed and written consent to participate.
- •Criteria exclusive to patients:
- •- Idiopathic Parkinson's disease according to United Kingdom Parkinson's criteria Brain Bank disease (Hughes et al., 1992).
排除标准
- •For all participants:
- •Major cognitive impairment (Moca < 22) or severe neurocognitive disorder according to DSM-V (Diagnostic and statistical manual of mental disorders -V);
- •Motor difficulties preventing the achievement of the task.
- •Drug or alcohol addiction.
- •Adult subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.
- •Present or past moderate to severe psychiatric pathology (obsessive compulsive, bipolar disorder, schizophrenia, etc.).
- •Potential for pregnancy or confirmed pregnancy. A pregnancy test will be performed on inclusion.for women of childbearing age.
- •Criteria exclusive to patients:
- •Present or past neurological pathology other than Parkinson's disease (accident stroke, head trauma, etc.).
- •Deep brain stimulation treatment.
- •Exclusive to healthy participants:
- •- Present or past neurological pathology.
研究组 & 干预措施
Patients with Parkinson disease
Patients with idiopathic PD. Will receive real or sham transcranial alternating current stimulation at the second visit according to the randomization order. The other stimulation condition will be applied at the third visit.
干预措施: Neuropsychological assessment (Other)
Patients with Parkinson disease
Patients with idiopathic PD. Will receive real or sham transcranial alternating current stimulation at the second visit according to the randomization order. The other stimulation condition will be applied at the third visit.
干预措施: Neurological assessment (Other)
Patients with Parkinson disease
Patients with idiopathic PD. Will receive real or sham transcranial alternating current stimulation at the second visit according to the randomization order. The other stimulation condition will be applied at the third visit.
干预措施: Cognitive task (Other)
Patients with Parkinson disease
Patients with idiopathic PD. Will receive real or sham transcranial alternating current stimulation at the second visit according to the randomization order. The other stimulation condition will be applied at the third visit.
干预措施: EEG (Procedure)
Patients with Parkinson disease
Patients with idiopathic PD. Will receive real or sham transcranial alternating current stimulation at the second visit according to the randomization order. The other stimulation condition will be applied at the third visit.
干预措施: tACS (real or sham) (Procedure)
Healthy volunteers
Healthy volunteers with no major cognitive impairment. Will receive real or sham transcranial alternating current stimulation at the second visit according to the randomization order. The other stimulation condition will be applied at the third visit.
干预措施: tACS (real or sham) (Procedure)
Healthy volunteers
Healthy volunteers with no major cognitive impairment. Will receive real or sham transcranial alternating current stimulation at the second visit according to the randomization order. The other stimulation condition will be applied at the third visit.
干预措施: Neuropsychological assessment (Other)
Healthy volunteers
Healthy volunteers with no major cognitive impairment. Will receive real or sham transcranial alternating current stimulation at the second visit according to the randomization order. The other stimulation condition will be applied at the third visit.
干预措施: Cognitive task (Other)
Healthy volunteers
Healthy volunteers with no major cognitive impairment. Will receive real or sham transcranial alternating current stimulation at the second visit according to the randomization order. The other stimulation condition will be applied at the third visit.
干预措施: EEG (Procedure)
结局指标
主要结局
Difference in cognitive performance measured by the stop signal reaction time (SSRT) compared between real and sham stimulation conditions
时间窗: 5 months
次要结局
- The difference in the dynamic changes in functional networks during the task between real and sham stimulation.(5 months)
- The difference in network parameters derived from graph theory between real and sham stimulation.(5 months)
- The existence of correlations between the changes in network measures between real and sham stimulation mentioned above and the behavioral differences measured between real and sham stimulation.(5 months)