Actively Recruiting
Analysis of the Analgesic Mechanism of TENS-WAA During Non-anesthetized Colonoscopy Using EEG-fNIRS System
Led by First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University · Updated on 2025-08-08
60
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
Sponsors
F
First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
Lead Sponsor
S
Shanghai Shuli Intelligent Technology Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a single-center, randomized controlled trial aiming to evaluate the analgesic mechanism of Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture (TENS-WAA) during unsedated colonoscopy using EEG-fNIRS technology to assess neural activity in brain regions associated with pain perception. Sixty patients aged 18-75 years, with stable cardiopulmonary function and a baseline visual analog scale (VAS) pain score \<3, will be enrolled and randomly allocated into the intervention and control groups. The intervention group will receive TENS stimulation based on the Wrist-Ankle Acupuncture theory 10 minutes before the colonoscopy, with a frequency of 2 Hz and adjustable current intensity ranging from 1 to 9 mA. The control group will receive minimal-intensity sham stimulation under identical conditions. All participants will wear EEG-fNIRS devices to monitor neural activity in key pain-related brain areas, including the prefrontal cortex, anterior cingulate cortex, motor cortex, and parietal cortex. Primary outcomes include EEG-fNIRS data, while secondary outcomes are VAS scores at the four colonic bends, colonoscopy duration, and the correlation between EEG-fNIRS signals and pain perception. Statistical analyses will include multivariable linear regression, generalized estimating equations, and mixed-effects models to investigate the analgesic effects and neural mechanisms of TENS-WAA. This study seeks to provide innovative pain management strategies for patients undergoing unsedated colonoscopy and further explore the neuroregulatory potential of TENS-WAA technology.
CONDITIONS
Official Title
Analysis of the Analgesic Mechanism of TENS-WAA During Non-anesthetized Colonoscopy Using EEG-fNIRS System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing unsedated colonoscopy are eligible for inclusion in this study.
- Aged 18 to 75 years.
- Meeting the requirements for colonoscopy, with good cardiopulmonary function and stable vital signs.
- A pre-procedural Visual Analog Scale (VAS) pain score of less than 3.
You will not qualify if you...
- Participants with speech or cognitive impairments.
- Those with acute anal or rectal stenosis, acute perianal or rectal infections, acute diverticulitis, or active inflammatory bowel disease.
- Women who are menstruating, pregnant, or breastfeeding.
- Patients with active tuberculosis, hemophilia, or advanced malignant tumors.
- Individuals with sensory disturbances, implanted pacemakers or defibrillators, or ankle skin ulcers.
- Those who have used sedatives or analgesics either long-term or within the past 24 hours.
- Individuals with any condition that interferes with EEG-fNIRS signal acquisition, such as cranial abnormalities, implanted metal or electronic devices, epilepsy, or neurological disorders.
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Naval Medical University
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
X
Xiaonan Huang, master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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