Study of Bipolar Disorders and Retinal Electrophysiological Markers

NCT05161546 | Terminated

• 2 other identifiers: RIPH 2021-03IDRCB 2021-A01644-37
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The BIMAR study aims to compare electrophysiological data measured with electroretinogram (ERG) and electroencephalogram (EEG) between a group of euthymic patients with bipolar disorder (BD) and a group of healthy controls subjects. Secondarily, the investigators also want to:

• Compare combined electrophysiological measurements with ERG and EEG between the two groups.
• Identify relations between clinical, neuropsychological and circadian phenotypes in patients with BD and electrophysiological measurements measured with ERG and EEG. The main hypothesis of the investigators is that differences exist in the ERG and EEG measurements between subjects with BD and healthy subjects. Those differences could be identified as candidate markers for BD which, if confirmed in later studies, could be used in current practice to guide the management of patients with BD.

Conditions

Bipolar Disorder

Keywords

bipolar disorder; biomarker; electroretinogram; electroencephalogram; neurocognition; actigraphy; retina

Outcome Measures

Primary Outcomes (2)

• Modification of amplitude measured with flash and pattern electroretinogram

  amplitude in microvolt

  Day 0 (=day of inclusion)

• Modification of implicite time measured with flash and pattern electroretinogram

  implicite time in millisecond

  Day 0 (=day of inclusion)

Secondary Outcomes (10)

• Modification of amplitude measured with electroencephalogram

  Day 0 (=day of inclusion)

• Modification of latency measured with electroencephalogram

  Day 0 (=day of inclusion)

• Actigraphy

  from Day1 to Day21

• Sleep diary

  from Day 1 to Day 21

• Visual Object and Space Perception battery (VOSP)

  visit n ° 2 (=between Day 22 and Day 27)

Other Outcomes (38)

• Mini International Neuropsychiatric Interview (MINI)

  Day 0 (=day of inclusion)

• Montgomery-Asberg Depression Rating Scale (MADRS)

  Day 0 (=day of inclusion)

• Montgomery-Asberg Depression Rating Scale (MADRS)

  at the visit n ° 2 (=between Day 22 and Day 27)

Study Arms (2)

patients with bipolar disorder (BD)

EXPERIMENTAL

Electrophysiological recordings with ERG and EEG will be performed with a virtual reality headset after a standardized clinical evaluation (first visit). Then, an actigraphic monitoring of 21 consecutive days will be carried out. At the end of this period a neuropsychological evaluation will be performed during a second visit. Between day 23 and day 28 (after the second visit), patients will be offered to assess the retinal structure and microvascularization using Spectral Domain Optical Coherence Tomography (SD-OCT) and OCT-Angiography (OCT-A).

Device: EEG and ERG measurements (Retinaute®, BioSerenity); Device: Actigraphy (Motion Watch 8®, CamNtech); Behavioral: Neuropsychological assessments; Device: Optical Coherence Tomography (OCT)

healthy volunteers

ACTIVE COMPARATOR

Electrophysiological recordings with ERG and EEG will be performed with a virtual reality headset after a standardized clinical evaluation (first visit). Then, an actigraphic monitoring of 21 consecutive days will be carried out. At the end of this period a neuropsychological evaluation will be performed during a second visit.

Device: EEG and ERG measurements (Retinaute®, BioSerenity); Device: Actigraphy (Motion Watch 8®, CamNtech); Behavioral: Neuropsychological assessments

Interventions

EEG and ERG measurements (Retinaute®, BioSerenity) DEVICE

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.

healthy volunteers; patients with bipolar disorder (BD)

Actigraphy (Motion Watch 8®, CamNtech) DEVICE

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.

healthy volunteers; patients with bipolar disorder (BD)

Neuropsychological assessments BEHAVIORAL

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.

healthy volunteers; patients with bipolar disorder (BD)

Optical Coherence Tomography (OCT) DEVICE

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.

patients with bipolar disorder (BD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients:
• been diagnosed with BD according to the Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) diagnostic criteria using the Mini International Neuropsychiatric Interview (MINI)
• currently euthymic for at least 3 months prior to the study, as defined by a score below 10 on the Montgomery-Asberg Depression Rating Scale (MADRS) which assesses depression and by a score below 8 on the Young Mania Rating Scale (YMRS) which assesses mania
• age 18 or more
• Healthy volunteers:
• not suffer from a personal psychiatric pathology verified with the MINI
• age 18 or more

You may not qualify if:

• suffer from psychiatric pathology or substance use disorders according to DSM-IV criteria measured with the MINI, excluding BD for the patient group
• suffer from neurological or retinal pathology
• having a shift work or a get-lag in the last 15 days
• criteria incompatible with the use of the virtual reality headset (Retinaute®,BioSerenity) like having an allergy to one of the components of the textile
• persons treated by sismotherapy during the past year
• persons with an uncorrected visual impairment or disabling hearing impairment that does not allow neuropsychological tests to be performed
• subjects with an intellectual disability making it difficult to participate in the study or to understand and follow informations provided to them
• adults legally protected
• pregnant or breastfeeding women
• subjects already participating in another interventional trial

Sponsors & Collaborators

• Centre Psychothérapique de Nancy: lead
• BioSerenity: collaborator

Study Sites (1)

Centre Psychothérapique de Nancy

Laxou, Nancy, 54520, France

Location

Related Publications (4)

• Schwitzer T, Schwan R, Bubl E, Lalanne L, Angioi-Duprez K, Laprevote V. Looking into the brain through the retinal ganglion cells in psychiatric disorders: A review of evidences. Prog Neuropsychopharmacol Biol Psychiatry. 2017 Jun 2;76:155-162. doi: 10.1016/j.pnpbp.2017.03.008. Epub 2017 Mar 20.

  PMID: 28336492 BACKGROUND

• Tan A, Schwitzer T, Conart JB, Angioi-Duprez K. Study of retinal structure and function in patients with major depressive disorder, bipolar disorder or schizophrenia: A review of the literature. J Fr Ophtalmol. 2020 May;43(5):e157-e166. doi: 10.1016/j.jfo.2020.04.004. Epub 2020 May 4.

  PMID: 32381369 BACKGROUND

• Hebert M, Merette C, Gagne AM, Paccalet T, Moreau I, Lavoie J, Maziade M. The Electroretinogram May Differentiate Schizophrenia From Bipolar Disorder. Biol Psychiatry. 2020 Feb 1;87(3):263-270. doi: 10.1016/j.biopsych.2019.06.014. Epub 2019 Jun 27.

  PMID: 31443935 BACKGROUND

• Gross G, Tursini K, Albuisson E, Angioi-Duprez K, Conart JB, Louis Dorr V, Schwan R, Schwitzer T. Bipolar disorders and retinal electrophysiological markers (BiMAR): Study protocol for a comparison of electroretinogram measurements between subjects with bipolar disorder and a healthy control group. Front Psychiatry. 2022 Sep 8;13:960512. doi: 10.3389/fpsyt.2022.960512. eCollection 2022.

  PMID: 36159928 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Electroencephalography; Actigraphy; Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Physiologic; Accelerometry; Investigative Techniques; Tomography, Optical; Optical Imaging; Diagnostic Imaging; Tomography

Study Officials

• Thomas SCHWITZER, MD, PhD

  Centre Psychothérapique de Nancy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The BiMAR study is an open-label and non-randomized comparative monocentric study applied in psychiatry and neuroscience. This research included two groups of adult subjects: a group of patients with BD in the euthymic phase and a group of healthy control subjects.

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: December 17, 2021
• Study Start: January 18, 2022
• Primary Completion: August 8, 2023
• Study Completion: August 8, 2023
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)