The Bipolar Lithium Imaging Scan Study.
The Bipolar Lithium Imaging Scan Study: Imaging Lithium in the Brains of Subjects with Bipolar Disorder
Leiden University Medical Center
80 participants
Mar 13, 2024
OBSERVATIONAL
Conditions
Summary
The main goal of this study is to determine if brain lithium-concentrations predict clinical lithium treatment-response. Secondary, to study correlations between intracerebral distribution-patterns of lithium with clinical treatment outcome. Brain lithium concentrations will be measured using ultra-high field (7 Tesla) lithium magnetic resonance (MR) imaging, which has recently been introduced. Determining lithium-concentrations in the brain has been difficult so far due to lithium's relatively low concentration (compared to protons, which are targeted in conventional MRI). 7T lithium MR imaging has the potential to produce much more detailed MR images compared with previous studies, for the first time. The BLISS study is expected to yield new insights, helping to better understand why clinical lithium response varies between individuals.
Eligibility
Inclusion Criteria4
- age 18 years or above,
- a clinical diagnosis of bipolar disorder type I or type II ,
- having reached stable therapeutic serum lithium concentrations (reference values 0.6-1.0 mM in age to 65 years; 0.4-0.8 in age 65 years and above) within four weeks prior to study participation, and
- provided written informed consent.
Exclusion Criteria4
- insufficient comprehension of the Dutch language,
- unable to provide informed consent,
- drug or alcohol abuse over a period of two weeks prior to study participation, and
- meeting any exclusion criterium for MR imaging.
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Interventions
After obtaining written informed consent and within four weeks of reaching a stable therapeutic serum lithium concentration, lithium MR imaging will be performed using a 7 Tesla MR system (Achieva, Philips Medical Systems, Eindhoven, The Netherlands) with a dual-tuned 7Li/1H volume head coil (RAPID Biomedical GmbH, Rimpar, Germany). Various approaches, including whole-brain, voxel-wise, parcellation, mean, and regions of interest, will be applied to measure lithium concentrations.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06134349