Analysis of the analgesic mechanism of TENS-WAA in colonoscopy using the EEG-fNIRS system: a study protocol for a randomised controlled trial.
Han Wang, Xiaonan Huang, Lifan Xu...
https://pubmed.ncbi.nlm.nih.gov/41033775Actively Recruiting
Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID06813703
Analysis of the Analgesic Mechanism of Transcutaneous Electrical Nerve Stimulation Based on Wrist-Ankle Acupuncture 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
24 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
Researchers are investigating the pain-relief mechanism of Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture (TENS-WAA) during unsedated colonoscopy. This single-center, randomized controlled trial uses EEG-fNIRS technology to monitor brain activity in areas linked to pain perception. Sixty patients aged 18 to 75 years with stable heart and lung function and low baseline pain scores will participate to better understand TENS-WAA's neuroregulatory effects on pain during colonoscopy. Participants will be randomly assigned to either the electrical stimulation group or the control group. In the stimulation group, electrodes will be placed on specific ankle zones and deliver electrical currents at the highest comfortable intensity below the pain threshold, with settings of 2 Hz frequency and 500 microseconds pulse width. The control group will have electrodes in the same positions but with minimal current intensity. Both groups will wear EEG-fNIRS devices to monitor brain regions such as the prefrontal cortex, anterior cingulate cortex, motor cortex, and parietal cortex during the procedure. During the study, neural activity data will be collected alongside pain scores measured by the visual analog scale at key points of the colonoscopy. The total time to reach certain colon bends and the ileocecal valve will also be recorded. Researchers will analyze correlations between brain signals and pain perception using advanced statistical models. The study aims to provide new approaches for pain management in unsedated colonoscopy and enhance understanding of TENS-WAA's effects. Participation lasts through the colonoscopy procedure with monitoring during and after.
CONDITIONS
Brief Title
Analysis of the Analgesic Mechanism of TENS-WAA During Non-anesthetized Colonoscopy Using EEG-fNIRS System
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients undergoing unsedated colonoscopy
- Age between 18 and 75 years
- Good cardiopulmonary function with stable vital signs
- Baseline Visual Analog Scale (VAS) pain score less than 3
You will not qualify if you...
- Speech or cognitive impairments
- Acute anal or rectal stenosis, infections, diverticulitis, or active inflammatory bowel disease
- Women who are menstruating, pregnant, or breastfeeding
- Active tuberculosis, hemophilia, or advanced malignant tumors
- Sensory disturbances, implanted pacemakers or defibrillators, or ankle skin ulcers
- Long-term or recent (within 24 hours) use of sedatives or analgesics
- Conditions interfering with EEG-fNIRS signal acquisition such as cranial abnormalities, implanted metal/electronic devices, epilepsy, or neurological disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - During colonoscopy procedure
Participants receive electrical stimulation using a device during non-anesthetized colonoscopy to relieve pain. Electrodes are placed on specific ankle locations and electrical currents are applied at settings based on group assignment.
1 visit (in-person)
Follow-up
Duration - Up to 24 weeks
Participants are monitored for correlations between brain activity and pain scores up to 24 weeks after the procedure.
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Naval Medical University
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Loading map...
Research Team
X
Xiaonan Huang, master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here