Investigation of the Benefits of Electrical Non-invasive Stimulation on Cognitive Symptoms in Parkinson's Disease (STIMPARK)

Institut National de la Santé Et de la Recherche Médicale, France

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Procedure: EEG; Other: Neuropsychological assessment; Other: Neurological assessment; Procedure: tACS (real or sham); Other: Cognitive task

Study type: Interventional

Funder types: Other

Identifiers

NCT05808504

2022- A00767-36 (Registry Identifier)

C21-76

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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90 participants in 2 patient groups

Patients with Parkinson disease

Experimental group

Description:

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.

Treatment:

Other: Cognitive task

Procedure: tACS (real or sham)

Other: Neurological assessment

Other: Neuropsychological assessment

Procedure: EEG

Healthy volunteers

Experimental group

Description:

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.

Treatment:

Other: Cognitive task

Procedure: tACS (real or sham)

Other: Neuropsychological assessment

Procedure: EEG