NCT06813703 Analysis of the Analgesic Mechanism of TENS-WAA During Non-anesthetized Colonoscopy Using EEG-fNIRS System
| NCT ID | NCT06813703 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University |
| Condition | Colonoscopy |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-02-18 |
| Primary Completion | 2025-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-02-18 with a primary completion date of 2025-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
1. Inclusion Criteria: * 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. 2. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06813703 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Colonoscopy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06813703 currently recruiting?
Yes, NCT06813703 is actively recruiting participants. Contact the research team at 1301090492@qq.com for enrollment information.
Where is the NCT06813703 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06813703 clinical trial?
NCT06813703 is sponsored by First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University. The trial plans to enroll 60 participants.