Actively Recruiting
Assessing the Cognitive Effects of Chronic Benzodiazepine Use in Patients: A Comprehensive Study Using fNIRs and PET/MRI Technologies
Led by The First Affiliated Hospital of Dalian Medical University · Updated on 2025-04-11
100
Participants Needed
1
Research Sites
18 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of long-term benzodiazepine (BZD) use on cognitive function and related brain changes. Benzodiazepines are commonly used to treat anxiety and insomnia, but recent warnings highlight potential risks such as neurocognitive impairment. This study aims to compare brain activity, metabolism, and inflammation between people who use BZDs long-term and those who do not, using advanced brain imaging techniques to better understand how BZDs affect the brain. The study involves three groups: people who have used benzodiazepines continuously for at least three months, individuals who have never used benzodiazepines, and healthy controls. Researchers will use functional near-infrared spectroscopy (fNIRS) to measure brain oxygen levels during cognitive tasks, along with PET/MRI scans to assess brain metabolism and neuroinflammation. These imaging tests will be combined with mood and cognitive assessments to provide a comprehensive view of brain function. Participants will be followed for three years, during which brain hemodynamic activity will be monitored with fNIRS. Neuroimaging biomarkers will be tracked over time using structural, functional, and multimodal MRI and PET scans. Cognitive and mood evaluations include the Mini-Mental State Examination, Hamilton Depression and Anxiety Scales, and the Pittsburgh Sleep Quality Index. This thorough monitoring will help researchers measure changes in brain function related to benzodiazepine use and understand its impact on cognition.
CONDITIONS
Brief Title
Benzodiazepine Impact on Cognitive Function: fNIRs and PET/MRI Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Continuous use of benzodiazepines for 3 months or more, or no prior benzodiazepine use
- At least 6 years of education
- Abstained from alcohol, coffee, and other psychoactive substances in the 24 hours before examination
You will not qualify if you...
- Brain damage from causes such as head trauma, dementia, epilepsy, or brain tumors
- Severe systemic diseases, including malignant tumors
- Acute cerebrovascular disease in the past 3 months
- History of substance abuse other than benzodiazepines
- Inability to cooperate with fNIRS, PET/MRI examinations, and scale assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants undergo neuroimaging assessments including functional near-infrared spectroscopy (fNIRS), FDG-PET/MRI, and DPA-714-PET/MRI to measure brain hemodynamic activity, metabolism, and neuroinflammation, along with cognitive and mood scale assessments.
Annual visits for up to 3 years
Duration - Up to 3 years
Participants are observed over time to track longitudinal changes in brain biomarkers and cognitive function related to benzodiazepine use.
Annual visits for up to 3 years
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China, 116000
Actively Recruiting
Research Team
H
Hui min Zhang
M
Mei chen Liu
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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