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NCT Number: NCT06813703

Analysis of the Analgesic Mechanism of TENS-WAA During Non-anesthetized Colonoscopy Using EEG-fNIRS System

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Naval Medical University

Shanghai, Shanghai Municipality, 200433, China

Location status: Recruiting

Location contact

Fanfu Fang, MD

PRINCIPAL_INVESTIGATOR

Xiaonan Huang, master

CONTACT

[email protected]

13912830811

xiaonan Huang, Master

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.
  • 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.

Treatment and study plan

Using an electrical stimulation device to relieve pain during colonoscopy

Device

In the electrical stimulation group, the device's current intensity will be adjusted to the maximum tolerance below the participant's pain threshold, while in the control group, the current intensity will be set to the minimum.

Primary outcomes

  1. NeuroActivity Correlation Index

    Time frame: during procedure

    The NeuroActivity Correlation Index is a metric calculated using machine learning models to quantify the correlation between EEG and fNIRS data. Data preprocessing involves selecting appropriate frequency bands of EEG Power Spectral Density and corresponding brain regions' ΔHbO2 and ΔHb changes, with normalization of the data. Feature engineering involves extracting statistical and temporal window features, possibly using dimensionality reduction techniques such as Principal Component Analysis to enhance model efficiency. The model training phase utilizes regression models such as linear regression or support vector machine regression, or methods like Canonical Correlation Analysis to discover correlations between EEG and fNIRS data, optimizing model parameters through cross-validation. The correlation index is calculated based on model outcomes, typically expressed as a percentage, reflecting the statistical correlation strength between the datasets.

Secondary outcomes

  1. Pain VAS score

    Time frame: during procedure (When the endoscope passes through the hepatic flexure, splenic area and rectosigmoid junction)

    VAS is used to assess pain. It is widely used in clinical practice in China. The basic method is to use a 10-cm long floating ruler with 10 scale marks on one side, with 0 and 10 marks at the two ends. 0 means no pain, and 10 means the most severe pain that is unbearable.

  2. Colonoscopy time

    Time frame: during procedure (The total time to reach the three bends and to the ileocecal valve and for the entire examination was recorded)

  3. Correlation between EEG-fNIRS and pain VAS scores

    Time frame: up to 24 weeks

    The neurophysiological and hemodynamic indicators were correlated with pain scores using AI machine learning methods.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaonan Huang, master

CONTACT

[email protected]

86+15700719913

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University

Other

Collaborators

  • Shanghai Shuli Intelligent Technology Co., Ltd

Registry information

Official study title

Analysis of the Analgesic Mechanism of Transcutaneous Electrical Nerve Stimulation Based on Wrist-ankle Acupuncture Theory During Non-anesthetized Colonoscopy Using Electroencephalogram-Functional Infrared Spectroscopy System

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 7, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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