Study of Bipolar Disorders and Retinal Electrophysiological Markers
- Conditions
- Bipolar Disorder
- Interventions
- Device: EEG and ERG measurements (Retinaute®, BioSerenity)Device: Actigraphy (Motion Watch 8®, CamNtech)Behavioral: Neuropsychological assessmentsDevice: Optical Coherence Tomography (OCT)
- Registration Number
- NCT05161546
- Lead Sponsor
- Centre Psychothérapique de Nancy
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 62
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description patients with bipolar disorder (BD) Actigraphy (Motion Watch 8®, CamNtech) 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 Neuropsychological assessments 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. patients with bipolar disorder (BD) EEG and ERG measurements (Retinaute®, BioSerenity) 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). patients with bipolar disorder (BD) Neuropsychological assessments 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). patients with bipolar disorder (BD) Optical Coherence Tomography (OCT) 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 Actigraphy (Motion Watch 8®, CamNtech) 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. healthy volunteers EEG and ERG measurements (Retinaute®, BioSerenity) 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.
- Primary Outcome Measures
Name Time Method Modification of implicite time measured with flash and pattern electroretinogram Day 0 (=day of inclusion) implicite time in millisecond
Modification of amplitude measured with flash and pattern electroretinogram Day 0 (=day of inclusion) amplitude in microvolt
- Secondary Outcome Measures
Name Time Method Actigraphy from Day1 to Day21 evaluation of sleep/wake cycles
Modification of amplitude measured with electroencephalogram Day 0 (=day of inclusion) amplitude of the P100, N170 and N200 waves amplitude in microvolt
Modification of latency measured with electroencephalogram Day 0 (=day of inclusion) latency of the P100, N170 and N200 waves latency in millisecond
California Verbal Learning Test (CVLT) visit n ° 2 (=between Day 22 and Day 27) assessment of verbal episodic memory
Visual Object and Space Perception battery (VOSP) visit n ° 2 (=between Day 22 and Day 27) test of visual cognition
Continuous Performance Task (CPT-III) visit n ° 2 (=between Day22 and Day27) test of sustained attention
Sleep diary from Day 1 to Day 21 self reported tool of sleeping and waking times
Montreal Cognitive Assessment (MoCA) visit n ° 2 (=between Day 22 and Day 27) screening assessment for detecting cognitive impairment
Test of Attention Assessment (TAP) visit n ° 2 (=between Day 22 and Day 27) test of attentional performance
Verbal Fluency Task visit n ° 2 (=between Day 22 and Day 27) test of verbal functioning
Trial Locations
- Locations (1)
Centre Psychothérapique de Nancy
🇫🇷Laxou, Nancy, France