Actively Recruiting
A Multi-center Clinical Longitudinal Study of Neuropathic Pain by Collecting Data on Patients' Brain Physiology and Cognitive Function
Led by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2024-11-13
2000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multi-center clinical longitudinal study to better understand neuropathic pain by examining patients' brain activity and cognitive function. The study collects detailed data on pain levels, sleep quality, social support, anxiety, depression, and cognitive tasks using various scales and imaging techniques. This observational research aims to track changes in these factors during acute pain episodes in adults aged 18 to 85 years. Participants diagnosed with neuropathic pain will join the study and receive standard care from the pain department while being observed over time. The study includes evaluations using pain scales like the Visual Analogue Scale (VAS) and digital pain grading (NRS), as well as assessments of sleep, anxiety, cognitive function, and brain activity through electroencephalogram (EEG) and near-infrared brain imaging (fNIRS). Follow-up continues up to three months after enrollment to monitor changes. During the study, participants will undergo various assessments including pain scoring, cognitive tests, emotional tasks, and questionnaires on sleep and social support. Brain function will be monitored using EEG and fNIRS. Researchers will evaluate measures such as pain intensity, sleep quality, anxiety and depression levels, and cognitive abilities at one month. Participants' progress will be closely observed throughout the study period, which lasts at least three months post-enrollment.
CONDITIONS
Brief Title
A Multi-center Clinical Longitudinal Study of Neuropathic Pain by Collecting Data
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must voluntarily agree to join and sign informed consent.
- Age between 18 and 85 years old, any gender.
- Body mass index (BMI) of 45 or less.
- Clinically diagnosed neuropathic pain with a pain VAS score of 4 or higher.
- No participation in drug or medical device trials within the last 3 months.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
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 - 1 month
Participants are observed while receiving routine diagnosis and treatment for neuropathic pain. Various assessments including pain scales, cognitive function tests, and brain imaging are conducted.
Multiple assessments during routine care visits
Duration - Up to 3 months after enrollment
Participants are followed up for additional observation up to 3 months after joining the study to track changes in pain and cognitive function.
Follow-up visits as scheduled up to 3 months
Trial Site Locations
Total: 1 location
1
Ke Ma
Shanghai, Yangpu, China, 200092
Actively Recruiting
Research Team
J
jingting chen, phd
K
ke ma, phd
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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