Actively Recruiting

Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID06250842

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

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

Long-term Monitoring

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

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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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