An observational study in Apathy and Bipolar Disorder, sponsored by Hospital Center Guillaume Régnier. Recruiting at 1 site in France. Open to participants aged 70 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-06.
Sponsored by Hospital Center Guillaume Régnier · Observational
The goal of this clinical trial is to identify reliable markers of apathy in elderly subjects with bipolar disorder, age between 70 and 85 years, in order to accurately identify subjects at high risk of progressing to dementia by measuring motor activity (actimetrics), recorded language and analysing brain changes (MRI).
Actimetry is the measurement and recording of body movements using an actimeter. This device is worn on the wrist and contains sensors capable of measuring and recording all movements, including those of very low intensity. An automated speech analysis using artificial intelligence is used to detect low-intensity anomalies, and we want to test whether individual differences correspond to individual differences in brain anatomy and function.
Researchers will compare elderly subjects with bipolar disorder and healthy volunteer, age between 70 and 85 years.
Participants will be asked to:
1,683 studies on the registry are indexed under Bipolar Disorder; 266 are open to participants now.
This study's planned enrollment of 30 is below the median of 159 across 348 observational studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →Hospital Center Guillaume Régnier is the lead sponsor of 8 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients treated in the old-age psychiatry department of the Pôle Hospitalo-Universitaire de Psychiatrie Adulte (PHUPA) for OABD may be offered participation in the study. Eligible patients according to the inclusion criteria will be recruited during standard visits at CHGR. Informed consent along with a document describing the study will be presented during visit.
Healthy volunteers will be recruited from the patient's relatives and/or via posters and/or the CHGR's internal networks.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Psychiatric conditions and or co-morbidities
Neurological and cerebral co-morbidities
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
the strategy procedure will consist of using actigraphy and MRI. The wGT3X-BT actigraph (wGT3x-BT) will be worn on the wrist for 5 days. The set up is made at Day 1. The actigraph will be programmed to automatically switch off after 4 full days of use (96 hours). After 5 full days (120 hours), the participant returns to the research center so the data are downloaded on a secured computer dedicated to store and analyse the data. At day 5, a MRI will be perform.The total acquisition time is about 45 minutes: * Degenerative: anatomical 3DT1 (\~5 minutes acquisition). * Inflammation: multicompartment imaging models (\~15 minutes acquisition) such as the Neurite Orientation and Dispersion Index (NODDI) are used to quantify in-vivo microstructure inflammation. * Vascular: 3D Fluid-attenuated inversion recovery (FLAIR \~5 minutes acquisition) and Arterial Spin labelling (ASL, \~8 minutes acquisition) * Functional connectivity: rs BOLD (\~10 minutes acquisition)
Other: Actigraphy and MRI
the strategy procedure will consist of using actigraphy and MRI. The wGT3X-BT actigraph (wGT3x-BT) will be worn on the wrist for 5 days. The set up is made at Day 1. The actigraph will be programmed to automatically switch off after 4 full days of use (96 hours). After 5 full days (120 hours), the participant returns to the research center so the data are downloaded on a secured computer dedicated to store and analyse the data. At day 5, a MRI will be perform.The total acquisition time is about 45 minutes: * Degenerative: anatomical 3DT1 (\~5 minutes acquisition). * Inflammation: multicompartment imaging models (\~15 minutes acquisition) such as the Neurite Orientation and Dispersion Index (NODDI) are used to quantify in-vivo microstructure inflammation. * Vascular: 3D Fluid-attenuated inversion recovery (FLAIR \~5 minutes acquisition) and Arterial Spin labelling (ASL, \~8 minutes acquisition) * Functional connectivity: rs BOLD (\~10 minutes acquisition)
Other: Actigraphy and MRI
All participants will wear a wGT3X-BT actigraph (wGT3x-BT) for 4 days. Actigraphs are collected back at Day 4, after full 96 hours, when coming to the MRI platform. There, they will undergo 45 minutes MRI that acquire MRI signals to quantify degenerative, inflammatory, vascular and functional cerebral features.
Compare Actigraphic measures acquired by OABD participants and with those of Healthy controls (HC)
These very complex and highly dimensional signals are reduced to a sum, for a given period of time, of the variations in acceleration (in g/sec) after pre-processing (band-pass filtering) for each participants (OABD and healthy controls
Time frame: during 4 days
speech biomarkers :Temporal, Source, Prosodic and Spectral speech features automatically derived from the audio recordings of 3 cognitive tasks.
To identify a set of speech biomarkers, specific to OABD (compared to HC), 3 cognitive tasks , verbal learning (with the Rey Auditory Verbal Learning Task), semantic verbal fluency task and narrative storytelling are implemented on the Milli® platform. Each of these tasks enable to derive temporal, source, prosodic and spectral features from remote recordings.
Time frame: baseline and only for OABD participants at 12 month and 36 month
MRI derived cerebral features, specific to OABD participants compared to Healthy control
measure cortical thickness and sub-cortical volumes to identify degenerative alterations measure water diffusion in several cellular compartments and appropriate multi compartment modeling (MCM) such as Neurite Orientation Diffusion and Dispersion Index (NODDI) to identify Inflammation Measure tissue blood flow Using arterial spin labeling (ASL) to identify Vascular health
Time frame: at Day 4
Plan to share: Undecided
Started Jul 2024 (actual). Primary completion is estimated for Jan 2026, 18 months after the start.
Of 95 non-industry observational studies under Bipolar Disorder, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 119. This study's planned 18 months is below that.
Counting every sponsor, half of 105 studies reached it within 64 months; a quarter within 31 and three quarters within 118.
How these figures are worked out, and which studies are left out of them.
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Hospital Center Guillaume Régnier