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

NARecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

May 3, 2023

Primary Completion Date

January 15, 2026

Study Completion Date

January 15, 2026

Conditions
Parkinson Disease
Interventions
OTHER

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)

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.

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)."

PROCEDURE

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.

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.

Trial Locations (1)

Unknown

RECRUITING

CHU de Rennes, Rennes

All Listed Sponsors
lead

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

OTHER_GOV