Clinical trial NCT05808504: Investigation of the Benefits of Electrical Non-invasive Stimulation on Cognitive Symptoms in Parkinson's Disease
Official title: Investigation of the Benefits of Electrical Non-invasive Stimulation on Cognitive Symptoms in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Transcranial alternating current stimulation
Inhibition
Cognitive symptom
High resolution encephalography
Parkinson disease
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2023-04-11
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The experimental phase will consist of 3 visits. A first one will consist of a neuropsychological exam with the MoCA, STAI, MADRS and LARS scales. Participants will also perform the Stop Task with an EEG recording. V1 has several purposes: check for inclusion criteria, define subject-specific frequency used for the stimulation, based on EEG analysis. With V1 we will also make sure that PD patients (recruited after controls), have an impaired performance at the task compared to controls. After V1, two other visits will be carried out with a 3 month interval. At V2, participants will be offered in a pseudo-randomized order either the real stimulation or the sham stimulation, with inhibition and EEG assessment (total time 45 min) before and after stimulation. The stimulation condition will be reversed during V3. V2 or V3 will also be accompanied by a brief neurological exam using the Hoehn and Yahr, and Schwab and England evaluations, and a measure of the levodopa equivalent daily dose.
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Difference in cognitive performance measured by the stop signal reaction time (SSRT) compared between real and sham stimulation conditions
timeFrame: 5 months
Secondary outcomes:
measure: The difference in the dynamic changes in functional networks during the task between real and sham stimulation.
timeFrame: 5 months
measure: The difference in network parameters derived from graph theory between real and sham stimulation.
timeFrame: 5 months
measure: 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.
timeFrame: 5 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
affiliation: Rennes University Hospital
name: Paul Sauleau, MD
role: PRINCIPAL_INVESTIGATOR
References: