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

NCT ID: NCT05808504

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-03
• Study Completion Date: 2026-01-15

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Neuropsychological assessment

Intervention Type: OTHER

interview with a neuropsychologist and carrying out tests measuring overall cognitive abilities, depression, apathy and anxiety (respectively using the MOCA, MADRS, LARS, STAI scales)

Neurological assessment

Intervention Type: OTHER

Only for patients with Parkinson disease. Evaluation consisting in a disease severity assessment using the Hoehn and Yahr and Schwab and England scales, as a well as a measure of levodopa equivalent daily dose.

Cognitive task

Intervention Type: OTHER

The task consists in pressing a left or right button as fast and as accurately as possible according to the direction of an arrow displayed at the center of a screen. On 25 % of the trials, a "stop" signal will occur right after the stimulus, indicating the participant to stop his impending button press. The delay between the presentation of the arrow stimulus and the stop signal will be adjusted to ensure a final 50% accuracy (decreased following an accurate response and increased after an error), which is necessary to comply with the assumptions for a robust calculation of the stop signal reaction time (SSRT).

EEG

Intervention Type: PROCEDURE

A high-resolution (256 channels) electroencephalographic recording will be done at rest and during the Stop task, before and after each real or sham stimulation.

tACS (real or sham)

Intervention Type: PROCEDURE

Real or sham 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 according to standard EEG position, and defined based on dosimetry analyses on averaged head models) 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.

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.

Group Type: EXPERIMENTAL

Neuropsychological assessment

Intervention Type: OTHER

interview with a neuropsychologist and carrying out tests measuring overall cognitive abilities, depression, apathy and anxiety (respectively using the MOCA, MADRS, LARS, STAI scales)

Cognitive task

Intervention Type: OTHER

The task consists in pressing a left or right button as fast and as accurately as possible according to the direction of an arrow displayed at the center of a screen. On 25 % of the trials, a "stop" signal will occur right after the stimulus, indicating the participant to stop his impending button press. The delay between the presentation of the arrow stimulus and the stop signal will be adjusted to ensure a final 50% accuracy (decreased following an accurate response and increased after an error), which is necessary to comply with the assumptions for a robust calculation of the stop signal reaction time (SSRT).

EEG

Intervention Type: PROCEDURE

A high-resolution (256 channels) electroencephalographic recording will be done at rest and during the Stop task, before and after each real or sham stimulation.

tACS (real or sham)

Intervention Type: PROCEDURE

Real or sham 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 according to standard EEG position, and defined based on dosimetry analyses on averaged head models) 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.

Interventions

Neuropsychological assessment

interview with a neuropsychologist and carrying out tests measuring overall cognitive abilities, depression, apathy and anxiety (respectively using the MOCA, MADRS, LARS, STAI scales)

Intervention Type: OTHER

Neurological assessment

Only for patients with Parkinson disease. Evaluation consisting in a disease severity assessment using the Hoehn and Yahr and Schwab and England scales, as a well as a measure of levodopa equivalent daily dose.

Intervention Type: OTHER

Cognitive task

The task consists in pressing a left or right button as fast and as accurately as possible according to the direction of an arrow displayed at the center of a screen. On 25 % of the trials, a "stop" signal will occur right after the stimulus, indicating the participant to stop his impending button press. The delay between the presentation of the arrow stimulus and the stop signal will be adjusted to ensure a final 50% accuracy (decreased following an accurate response and increased after an error), which is necessary to comply with the assumptions for a robust calculation of the stop signal reaction time (SSRT).

Intervention Type: OTHER

EEG

A high-resolution (256 channels) electroencephalographic recording will be done at rest and during the Stop task, before and after each real or sham stimulation.

Intervention Type: PROCEDURE

tACS (real or sham)

Real or sham 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 according to standard EEG position, and defined based on dosimetry analyses on averaged head models) 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Sauleau, MD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

CHU de Rennes

Rennes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Paul Sauleau, MD

Role: CONTACT

paul.sauleau@chu-rennes.fr

+332 99 28 42 58

Julien Modolo, PHD

Role: CONTACT

julien.modolo@inserm.fr

+332 23 23 62 20

Facility Contacts

Paul Sauleau, MD

Role: primary

paul.sauleau@chu-rennes.fr

+332 99 28 42 58

Other Identifiers

2022- A00767-36

Identifier Type: REGISTRY

Identifier Source: secondary_id

C21-76

Identifier Type: -

Identifier Source: org_study_id