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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB 2021-A01644-37 | Other Identifier | ANSM |
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Malfunctions of the Retinaute® but no adverse effects on participants. Study interrupted for BioSerenity to make technical corrections. Long immobilization of the device and conditions for reusing it not adapted to the continuation of the study.
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| Name | Class |
|---|---|
| BioSerenity | INDUSTRY |
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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:
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.
Bipolar disorders (BD) is a common, chronic and disabling psychiatric condition. In addition to being characterized by significant clinical heterogeneity, notable disturbances of sleep and cognitive function are frequently observed in all phases of the disease. Currently, there is no readily available biomarker in current clinical practice to help diagnose or predict the disease course. Thus, identification of biomarkers in BD is today a major challenge. In this context, the study of electrophysiological biomarkers based on electroretinogram (ERG) and electroencephalogram (EEG) measurements in BD seems highly promising. The BiMAR study aims to compare electrophysiological data measured with ERG and EEG between a group of euthymic patients with BD and a group of healthy control subjects. Secondarily, the investigators will also describe the existing potential relationship between clinical, sleep and neuropsychological phenotypes of patients and electrophysiological data.
The BiMAR study is a comparative and monocentric study carried out at the Expert Center for BD in Nancy, France. In total, 70 euthymic adult patients with BD and 70 healthy control subjects will be recruited. Electrophysiological recordings with ERG and EEG will be performed with a virtual reality headset after a standardized clinical evaluation to all participants. 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. The primary outcome will be electrophysiological measurements with ERG flash and pattern. Secondary outcomes will be EEG data, sleep settings, clinical and neuropsychological assessments. For patients only, a complementary ancillary study, carried out at the University Hospital of Nancy, will be proposed to assess the retinal structure and microvascularization using Optical Coherence Tomography. Recruitment will begin in December 2021 and will continue until the end of June 2023.
The BiMAR study will contribute to identifying candidate ERG electrophysiological markers for helping the diagnosis of BD and identify subgroups of patients with different clinical profiles. Eventually, this would allow earlier diagnosis and personalized therapeutic interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Modification of amplitude measured with electroencephalogram | amplitude of the P100, N170 and N200 waves amplitude in microvolt | Day 0 (=day of inclusion) |
| Modification of latency measured with electroencephalogram |
| Measure | Description | Time Frame |
|---|---|---|
| Mini International Neuropsychiatric Interview (MINI) | questionnaire to diagnose psychiatric disorders | Day 0 (=day of inclusion) |
| Montgomery-Asberg Depression Rating Scale (MADRS) | rating scale measuring depressive symptoms |
Inclusion criteria :
Patients:
Healthy volunteers:
Exclusion criteria for all participants (patients and healthy volunteers):
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| Name | Affiliation | Role |
|---|---|---|
| Thomas SCHWITZER, MD, PhD | Centre Psychothérapique de Nancy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Psychothérapique de Nancy | Laxou | Nancy | 54520 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28336492 | Background | 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. | |
| 32381369 | Background |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004569 | Electroencephalography |
| D056044 | Actigraphy |
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D003943 | Diagnostic Techniques, Neurological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
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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.
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|
| 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. |
|
| 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. |
|
| 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. |
|
latency of the P100, N170 and N200 waves latency in millisecond
| Day 0 (=day of inclusion) |
| Actigraphy | evaluation of sleep/wake cycles | from Day1 to Day21 |
| Sleep diary | self reported tool of sleeping and waking times | from Day 1 to Day 21 |
| Visual Object and Space Perception battery (VOSP) | test of visual cognition | visit n ° 2 (=between Day 22 and Day 27) |
| California Verbal Learning Test (CVLT) | assessment of verbal episodic memory | visit n ° 2 (=between Day 22 and Day 27) |
| Continuous Performance Task (CPT-III) | test of sustained attention | visit n ° 2 (=between Day22 and Day27) |
| Verbal Fluency Task | test of verbal functioning | visit n ° 2 (=between Day 22 and Day 27) |
| Test of Attention Assessment (TAP) | test of attentional performance | visit n ° 2 (=between Day 22 and Day 27) |
| Montreal Cognitive Assessment (MoCA) | screening assessment for detecting cognitive impairment | visit n ° 2 (=between Day 22 and Day 27) |
| Day 0 (=day of inclusion) |
| Montgomery-Asberg Depression Rating Scale (MADRS) | rating scale measuring depressive symptoms | at the visit n ° 2 (=between Day 22 and Day 27) |
| Young Mania Rating Scale (YMRS) | rating scale measuring manic symptoms | Day 0 (=day of inclusion) |
| Young Mania Rating Scale (YMRS) | rating scale measuring manic symptoms | at the visit n ° 2 (=between Day 22 and Day 27) |
| Pittsburgh Sleep Quality Index (PSQI) | assess the subjective quality of sleep during the past month | Day 0 (=day of inclusion) |
| Pittsburgh Sleep Quality Index (PSQI) | assess the subjective quality of sleep during the past month | at the visit n ° 2 (=between Day 22 and Day 27) |
| Insomnia Severity Index (ISI) | assess the severity of insomnia | Day 0 (=day of inclusion) |
| Insomnia Severity Index (ISI) | assess the severity of insomnia | at the visit n ° 2 (=between Day 22 and Day 27) |
| Epworth sleepiness scale (ESS) | assess the daytime sleepiness | Day 0 (=day of inclusion) |
| Epworth sleepiness scale (ESS) | assess the daytime sleepiness | at the visit n ° 2 (=between Day 22 and Day 27) |
| Horne and Ostberg circadian typology questionnaire | assess the circadian rhythm type by evaluating the daily sleep-wake habits and the times of day when certain activities are performed with preferences | Day 0 (=day of inclusion) |
| Horne and Ostberg circadian typology questionnaire | assess the circadian rhythm type by evaluating the daily sleep-wake habits and the times of day when certain activities are performed with preferences | at the visit n ° 2 (=between Day 22 and Day 27) |
| Composite Scale of Morningness (CSM) | measure of behavioral temporal preference | Day 0 (=day of inclusion) |
| Composite Scale of Morningness (CSM) | measure of behavioral temporal preference | at the visit n ° 2 (=between Day 22 and Day 27) |
| Circadian Type Inventory (CTI) | assess of amplitude and stability of rhythms | Day 0 (=day of inclusion) |
| Circadian Type Inventory (CTI) | assess of amplitude and stability of rhythms | at the visit n ° 2 (=between Day 22 and Day 27) |
| The Berlin Questionnaire | estimate the risk of Obstructive Sleep Apnea syndrome | Day 0 (=day of inclusion) |
| The Berlin Questionnaire | estimate the risk of Obstructive Sleep Apnea syndrome | at the visit n ° 2 (=between Day 22 and Day 27) |
| Quick Inventory of Depressive Symptomatology self-report (QIDS-SR) | self reported rating scale measuring depressive symptoms | Day 0 (=day of inclusion) |
| Altman Self-Rating Mania Scale (ALTMAN) | self reported rating scale measuring manic symptoms | Day 0 (=day of inclusion) |
| State Trait Inventory Anxiety (STAI-A) | self reported rating scale measuring anxiety symptoms | Day 0 (=day of inclusion) |
| Multidimensional Assessment of Thymic States (MATHYS) | self reported assessment of emotional reactivity | Day 0 (=day of inclusion) |
| Patient Rated Inventory of Side Effects (PRISE-M) | self reported assessment of tolerance to treatments | Day 0 (=day of inclusion) |
| Medication Adherence Rating (MARS) | self reported assessment of adherence to treatments | Day 0 (=day of inclusion) |
| Alda Scale | assess response to lithium treatment | Day 0 (=day of inclusion) |
| Functioning Assessment Short Test (FAST) | assess patient's functioning | Day 0 (=day of inclusion) |
| Clinical Global Impression Scale (CGI) | assess patient's functioning | Day 0 (=day of inclusion) |
| Affective Instability Measure (AIM) | assess oscillations of intense affect | Day 0 (=day of inclusion) |
| Affective Lability Scale (ALS) | assess the emotional lability | Day 0 (=day of inclusion) |
| Buss-Durkee Hostility Inventory (BDHI) | assess the hostility | Day 0 (=day of inclusion) |
| Barrat Impulsivity Scale (BIS-10) | assess the impulsivity | Day 0 (=day of inclusion) |
| Wender Utah Rating Scale (WURS) | check for a history of attention deficit hyperactivity disorder | Day 0 (=day of inclusion) |
| Childhood Trauma Questionnaire (CTQ) | check for trauma in childhood | Day 0 (=day of inclusion) |
| Fagerström test | assess the tobacco addiction | Day 0 (=day of inclusion) |
| Edinburgh Handedness Inventory | assess the manual preference | Day 0 (=day of inclusion) |
| Spectral Domain Optical Coherence Tomography (SD-OCT) | evaluation of retinal structure | between Day 23 and Day 28 |
| Optical Coherence Tomography Angiography (OCT-A) | evaluation of retinal vascularity | between Day 23 and Day 28 |
| 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. |
| 31443935 | 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. |
| 36159928 | Derived | 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. |
| D008991 | Monitoring, Physiologic |
| D061725 | Accelerometry |
| D008919 | Investigative Techniques |
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D014054 | Tomography |