Protocol Section
The Protocol Section is one of the main sections in ClinicalTrials.gov data structure. It contains protocol-related information for clinical trials, including identification, status, design, eligibility, and other key details about how the trial is structured and conducted.
Protocol Section path is as follows:
Study -> Protocol Section -> Protocol Modules (Identification, Status, Design, Eligibility, etc.)
Protocol Section
Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-24 @ 7:25 PM
NCT ID:
NCT06813703
Description:
De-identified individual participant data (IPD) that will be shared include:
Demographic information (age, sex, colonoscopy history)
Group allocation (TENS-WAA or sham stimulation)
Pain Visual Analogue Scale (VAS) scores at key time points
EEG and fNIRS raw and pre-processed data collected before, during, and after colonoscopy
Procedure duration and event timepoints (e.g., reaching hepatic flexure, splenic flexure, ileocecal valve)
Relevant clinical outcomes (e.g., adverse events, procedure completion status) The data will be available from the corresponding author upon reasonable request, following publication of the main results and with a signed data access agreement. No data that could directly identify individual participants will be shared.
Study:
NCT06813703
Study Brief:
Analysis of the Analgesic Mechanism of TENS-WAA During Non-anesthetized Colonoscopy Using EEG-fNIRS System