Investigation of the Benefits of Electrical Non-invasive Stimulation on Cognitive Symptoms in Par… (NCT05808504) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Investigation of the Benefits of Electrical Non-invasive Stimulation on Cognitive Symptoms in Parkinson's Disease
France90 participantsStarted 2023-05-03
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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).
Exclusion Criteria:
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in cognitive performance measured by the stop signal reaction time (SSRT) compared between real and sham stimulation conditions
Timeframe: 5 months
Trial details
NCT IDNCT05808504
SponsorInstitut National de la Santé Et de la Recherche Médicale, France