Apathy-related Neurobehavioral Markers of Cognitive Decline in Old-age Bipolar Disorders: Proof-of-concept

Sponsor
Hospital Center Guillaume Régnier
Study ID
NCT06914284
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
70 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Actigraphy and MRI — OTHER
    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.

Study Details

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: * Perform an MRI * Complete 3 cognitive tests: verbal memory, verbal fluency and an emotional storytelling task, in which you will be asked to describe a memory orally using positive, negative and neutral emotions. * wear an actimeter on your wrist for 4 days.

Key Dates

First listed
Apr 6, 2025
Start date
Jul 1, 2024
Status verified
Apr 2025
Primary completion
Jan 31, 2026
Completion
Jan 31, 2029

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Old Age Bipolar Disorder
    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)
  • Arm: Healthy Controls
    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)

Primary Outcome Measure

Compare Actigraphic measures acquired by OABD participants and with those of Healthy controls (HC) [ Time Frame: during 4 days ]

Central Contacts

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