Benzodiazepine Impact on Cognitive Function: fNIRs and PET/MRI Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorThe First Affiliated Hospital of Dalian Medical University
About this trial
This study explores the impact of long-term benzodiazepine (BZDs) use on cognitive function and associated neuroimaging markers. While BZDs are established treatments for conditions like anxiety and insomnia, recent warnings highlight risks, including neurocognitive effects. Neuroimaging studies indicate potential neuroprotective effects of BZDs. Functional near-infrared spectroscopy (fNIRS) measures cerebral cortex function during cognitive tasks. Combining fNIRS with mood and cognitive scales, this study assesses cortical activation. 2-deoxy-2-fluoro-D-glucose-positron emission tomography (FDG-PET) evaluates brain metabolism. DPA-714 PET assesses neuroinflammation. The primary objective is to compare brain functional activation, metabolism, and neuroinflammatory levels between long-term BZD users and non-users. This comprehensive approach aims to provide insights into BZD effects on cognition and associated brain markers.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Continuous use of benzodiazepines for ≥3 months, matched with participants who have not taken benzodiazepines.
Education time ≥6 years.
Abstained from alcohol, coffee, and other psychoactive substances in the 24 hours before the examination.
Disqualifiers
Brain damage due to various reasons (such as head trauma, dementia, epilepsy, brain tumors, etc.).
Severe systemic diseases (such as malignant tumors, etc.).
Acute cerebrovascular disease in the past 3 months. History of substance abuse other than benzodiazepines (such as alcohol, opioids, etc.).
Inability to cooperate with fNIRS, PET/MRI examinations, and scale assessments.
Trial population
The First Affiliated Hospital of Dalian Medical University
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 3 trial groupsGroup A: Long-term benzodiazepine use group
Group B: Non-benzodiazepine use group
Group C: Healthy Controls
Trial outcomes
Primary outcomes
1
Brain hemodynamic activity with fNIRS
This includes changes in the concentration of oxygenated and deoxygenated hemoglobin as measured by the change in light absorption, along with comprehensive analyses of activation values and functional connectivity.
Time frame
for 3 years2
Longitudinal evolution of biomarkers measured from neuroimaging (including structural, functional, and multimodal MRI) and molecular neuroimaging (18F-FDG PET/MRI、DPA-714-PET/MRI)
Estimates of brain TSPO concentrations measured with PET will serve as a marker for neuroinflammation. Variation of the regional cerebral glucose consumption and TSPO-PET measures, derived from neuroimaging (including structural, functional, and multimodal MRI), will be compared between three groups.
Time frame
for 3 yearsSecondary outcomes
1
Mini-Mental State Evaluation (MMSE)
Clinician-administered screening tool used to systematically and thoroughly assess mental status through five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. Scores range between 0-30. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment.
Time frame
About 15 min during the study visit2
Scores of Hamilton Depression Scale
Using to assess depressive symptoms. With higher scores associated with more severe depression symptoms. Total scores \<7 is normal; Mild depression with total scores of 7～17; Moderate depression with total scores of 18～24; Total scores \>24 for severe depression.
Time frame
About 15 min during the study visit3
Scores of Hamilton Anxiety Scale
Using to assess anxiety symptoms. With higher scores associated with more severe anxiety symptoms. Total scores\< 7 indicates no anxiety; Total scores≥7 indicates possible anxiety; Total scores≥14 indicates anxiety; Total scores≥21 indicates obvious anxiety; Total scores≥29 points indicates serious anxiety.
Time frame
About 15 min during the study visit4
Pittsburgh Sleep Quality Index
Using to assess the sleep quality. Total scores of 0-5 indicates that the quality of sleep is very good, 6～10 indicates that the quality of sleep is OK, 11～15 indicates that the quality of sleep is average, and 16～21 indicates that the quality of sleep is poor.
Time frame
About 15 min during the study visitSponsors and contacts
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Source ClinicalTrials.gov