Study of Bipolar Disorders and Retinal Electrophysiological Markers

NATerminatedINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

January 18, 2022

Primary Completion Date

August 8, 2023

Study Completion Date

August 8, 2023

Conditions
Bipolar Disorder
Interventions
DEVICE

EEG and ERG measurements (Retinaute®, BioSerenity)

"The Retinaute® is a portable medical device developed by BioSerenity, France, for performing flash and pattern ERG. It comes in the form of a virtual reality headset, which can be used in outpatient facilities. It is non-invasive and uses skin electrodes for the collection of parameters.~ERG signals will be supplemented with 4 EEG channels, via cup electrodes applied to the skull and allowing the concomitant performance of an EEG."

DEVICE

Actigraphy (Motion Watch 8®, CamNtech)

"Actigraphy is an ecological and non-invasive method allowing a reliable characterization of the sleep/wake cycle. It is a portable system for continuously measuring the motor activity of an individual and appreciating the alternation of activity periods (wakefulness) and rest periods (sleep).~An actigraph (MotionWatch8®, CamNtech) looks like a wristwatch that will be worn continuously, by convention on the wrist of the non-dominant hand, over periods ranging from several days to several weeks (here 21 days). Actigraphy does not present a known risk."

BEHAVIORAL

Neuropsychological assessments

The purpose of this assessment is to establish a cognitive profile for each participant. It uses a series of tests widely described in the literature and commonly used today.

DEVICE

Optical Coherence Tomography (OCT)

The Spectral Domain Optical Coherence Tomography (SD-OCT) is a modern ocular imaging process using infrared radiation and allowing to obtain in a few seconds, and in a non-invasive way, images in section of the eye. The OCT-Angiography (OCT-A) module increments on the OCT. It can detect the movement of the blood elements from sequential SD-OCT slices taken at the same location of the retina and obtain a map of the retinal and choroidal vessels, without injection of fluorescent dye. The device used for both exams will be the OCT spectral RS 3000 Advance 2 + Angioscan (NIDEK, Gamagori, Japan). SD-OCT and OCT-A examinations are fast, painless, non-contact and last less than a minute. There is no particular risk.

Trial Locations (1)

54520

Centre Psychothérapique de Nancy, Laxou

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

BioSerenity

INDUSTRY

lead

Centre Psychothérapique de Nancy

OTHER

NCT05161546 - Study of Bipolar Disorders and Retinal Electrophysiological Markers | Biotech Hunter | Biotech Hunter