ColonoscopyNCT06813703
Analysis of the Analgesic Mechanism of TENS-WAA During Non-anesthetized Colonoscopy Using EEG-fNIRS System
A study testing Using an electrical stimulation device to relieve pain during colonoscopy in people with Colonoscopy and Pain, run by First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy, Pain
- What is being tested?
- Using an electrical stimulation device to relieve pain during colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2025to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Naval Medical University
Shanghai, Shanghai Municipality, 200433
About this study
Official 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
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
- Colonoscopy, Pain
- Being tested
- Using an electrical stimulation device to relieve pain during colonoscopy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using an electrical stimulation device to relieve pain during colonoscopyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Electrical stimulation group | Experimental | According to the WAA theory, the selected Lower Zone 1 (LZ1) and Lower Zone 2 (LZ2) are defined as follows: LZ1 is located between the medial Achilles tendon and the medial malleolus, while LZ2 is positioned at the central inner edge of the ankle joint, near the posterior border of the tibia. Two electrode pads will be placed on each LZ1 and LZ2 of both legs, totaling eight electrode pads. The TENS-WAA device will be set to a frequency of 2 Hz, a pulse width of 500 μs, and a continuous waveform. Participants in the stimulation group will receive electrical currents at their maximum tolerable intensity below the pain threshold. Receives: Device: Using an electrical stimulation device to relieve pain during colonoscopy |
| control group | Placebo comparator | Participants in the control group will have the electrodes placed in the same positions as those in the stimulation group, with identical electrical stimulation frequency and pulse width settings. However, the current intensity will be set to the minimum level. Receives: Device: Using an electrical stimulation device to relieve pain during colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG-fNIRS Neurovascular Coupling Peak β Coefficient
Neurovascular coupling is quantified from synchronized electroencephalography (EEG) and functional near-infrared spectroscopy (fNIRS) recordings. EEG activity is decomposed into predefined delta, theta, alpha, and beta frequency bands, and band-specific power envelopes are coupled with fNIRS-derived oxygenated haemoglobin (HbO) signals within predefined cortical regions of interest. A 10-second lag is applied to account for the delayed haemodynamic response following neural activity. Coupling is estimated using a general linear model. The peak β coefficient within the predefined analysis window is used to quantify maximum EEG-fNIRS neurovascular coupling strength. Values are calculated separately for the predefined frequency bands and cortical regions of interest and compared between the distal transcutaneous electrical nerve stimulation and sham stimulation groups.
Measured: During colonoscopy, at predefined procedural stages including anal intubation, splenic flexure, hepatic flexure, and cecal intubation, within the prespecified analysis window for each stage.
EEG-fNIRS Neurovascular Coupling β Area Under the Curve
Neurovascular coupling is quantified from synchronized electroencephalography (EEG) and functional near-infrared spectroscopy (fNIRS) recordings. EEG activity is decomposed into predefined delta, theta, alpha, and beta frequency bands, and band-specific power envelopes are coupled with fNIRS-derived oxygenated haemoglobin (HbO) signals within predefined cortical regions of interest. A 10-second lag is applied to account for the delayed haemodynamic response following neural activity. Coupling is estimated using a general linear model. The area under the β-coefficient curve (β AUC) within the predefined analysis window is used to quantify cumulative EEG-fNIRS neurovascular coupling strength over time. Values are calculated separately for the predefined frequency bands and cortical regions of interest and compared between the distal transcutaneous electrical nerve stimulation and sham stimulation groups.
Measured: During colonoscopy, at predefined procedural stages including anal intubation, splenic flexure, hepatic flexure, and cecal intubation, within the prespecified analysis window for each stage.
Secondary outcomes (6)
Pain VAS score
Pain intensity is assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Participants report their pain intensity at three predefined procedural stages during colonoscopy: passage of the endoscope through the rectosigmoid junction, splenic flexure, and hepatic flexure.
Measured: During colonoscopy, when the endoscope passes through the rectosigmoid junction, splenic flexure, and hepatic flexure.
EEG-Derived Cortical Neural Activity
Cortical neural activity is assessed using electroencephalography (EEG) during predefined stages of colonoscopy. After signal preprocessing and artefact removal, EEG activity is analysed in four predefined frequency bands: delta, theta, alpha, and beta. Outcome measures include relative spectral power, reflecting frequency-specific cortical activity, and pairwise EEG coherence, reflecting functional synchronization between cortical regions. Stage-specific changes relative to the corresponding resting-state reference and between-group differences are evaluated to characterize alterations in cortical neural activity and network organization associated with procedural visceral pain and distal transcutaneous electrical nerve stimulation.
Measured: During colonoscopy at predefined procedural stages, including anal intubation, splenic flexure, hepatic flexure, and ileocecal valve.
fNIRS-Derived HbO Cortical Activation
Cortical activation is assessed using oxygenated haemoglobin (HbO) signals recorded by functional near-infrared spectroscopy (fNIRS). Event-related HbO responses are analysed using a general linear model within prespecified post-event time windows. Channel-wise β coefficients are estimated relative to position-matched resting-state recordings and are used to quantify the magnitude and direction of cortical HbO activation.
Measured: During colonoscopy, at predefined procedural stages including anal intubation, splenic flexure, hepatic flexure, and cecal intubation, within the prespecified post-event analysis window for each stage.
fNIRS-Derived HbR Cortical Activation
Cortical activation is assessed using deoxygenated haemoglobin (HbR) signals recorded by functional near-infrared spectroscopy (fNIRS). Event-related HbR responses are analysed using a general linear model within prespecified post-event time windows. Channel-wise β coefficients are estimated relative to position-matched resting-state recordings and are used to quantify the magnitude and direction of cortical HbR activation.
Measured: During colonoscopy, at predefined procedural stages including anal intubation, splenic flexure, hepatic flexure, and cecal intubation, within the prespecified post-event analysis window for each stage.
fNIRS-Derived Cortical Functional Connectivity
Cortical functional connectivity is assessed from fNIRS signals during predefined stages of colonoscopy. Functional connectivity between prespecified fNIRS channels or cortical regions is quantified using pairwise correlation coefficients to characterize stage-specific changes in cortical haemodynamic network organization. Connectivity measures are compared between the distal transcutaneous electrical nerve stimulation and control conditions.
Measured: During colonoscopy, at predefined procedural stages including anal intubation, splenic flexure, hepatic flexure, and cecal intubation.
Colonoscopy time
Measured: during procedure (The total time to reach the three bends and to the ileocecal valve and for the entire examination was recorded)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start18 Feb 2025
- Primary completion1 Feb 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Shuli Intelligent Technology Co., Ltd
- Responsible party
- Principal investigator, Xiaonan Huang, First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813703
- Sponsor's protocol ID
- CHEC2025-006
- Status last verified
- Aug 2026
- First submitted
- 16 Jan 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Wang H, Huang X, Xu L, Guo S, Gong C, Mengcheng C, Wang W, Wang H, Fang F. Analysis of the analgesic mechanism of TENS-WAA in colonoscopy using the EEG-fNIRS system: a study protocol for a randomised controlled trial. BMJ Open. 2025 Sep 30;15(9):e103681. doi: 10.1136/bmjopen-2025-103681.
PubMed 41033775
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06813703
- Acronym / sponsor ID
- CHEC2025-006
- Conditions
- Colonoscopy, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical UniversityUniversity, hospital or other
- Collaborators
- Shanghai Shuli Intelligent Technology Co., Ltd
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrical stimulation group | Experimental | Device: Using an electrical stimulation device to relieve pain during colonoscopyAccording to the WAA theory, the selected Lower Zone 1 (LZ1) and Lower Zone 2 (LZ2) are defined as follows: LZ1 is located between the medial Achilles tendon and the medial malleolus, while LZ2 is positioned at the central inner edge of the ankle joint, near the posterior border of the tibia. Two electrode pads will be placed on each LZ1 and LZ2 of both legs, totaling eight electrode pads. The TENS-WAA device will be set to a frequency of 2 Hz, a pulse width of 500 μs, and a continuous waveform. Participants in the stimulation group will receive electrical currents at their maximum tolerable intensity below the pain threshold. |
| control group | Placebo comparator | Device: Using an electrical stimulation device to relieve pain during colonoscopyParticipants in the control group will have the electrodes placed in the same positions as those in the stimulation group, with identical electrical stimulation frequency and pulse width settings. However, the current intensity will be set to the minimum level. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Using an electrical stimulation device to relieve pain during colonoscopyIn 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. | Device | Electrical stimulation group, control group |
Primary outcome
EEG-fNIRS Neurovascular Coupling Peak β Coefficient
Time frame: During colonoscopy, at predefined procedural stages including anal intubation, splenic flexure, hepatic flexure, and cecal intubation, within the prespecified analysis window for each stage.
Neurovascular coupling is quantified from synchronized electroencephalography (EEG) and functional near-infrared spectroscopy (fNIRS) recordings. EEG activity is decomposed into predefined delta, theta, alpha, and beta frequency bands, and band-specific power envelopes are coupled with fNIRS-derived oxygenated haemoglobin (HbO) signals within predefined cortical regions of interest. A 10-second lag is applied to account for the delayed haemodynamic response following neural activity. Coupling is estimated using a general linear model. The peak β coefficient within the predefined analysis window is used to quantify maximum EEG-fNIRS neurovascular coupling strength. Values are calculated separately for the predefined frequency bands and cortical regions of interest and compared between the distal transcutaneous electrical nerve stimulation and sham stimulation groups.
EEG-fNIRS Neurovascular Coupling β Area Under the Curve
Time frame: During colonoscopy, at predefined procedural stages including anal intubation, splenic flexure, hepatic flexure, and cecal intubation, within the prespecified analysis window for each stage.
Neurovascular coupling is quantified from synchronized electroencephalography (EEG) and functional near-infrared spectroscopy (fNIRS) recordings. EEG activity is decomposed into predefined delta, theta, alpha, and beta frequency bands, and band-specific power envelopes are coupled with fNIRS-derived oxygenated haemoglobin (HbO) signals within predefined cortical regions of interest. A 10-second lag is applied to account for the delayed haemodynamic response following neural activity. Coupling is estimated using a general linear model. The area under the β-coefficient curve (β AUC) within the predefined analysis window is used to quantify cumulative EEG-fNIRS neurovascular coupling strength over time. Values are calculated separately for the predefined frequency bands and cortical regions of interest and compared between the distal transcutaneous electrical nerve stimulation and sham stimulation groups.
6 secondary outcomes
Pain VAS score
Time frame: During colonoscopy, when the endoscope passes through the rectosigmoid junction, splenic flexure, and hepatic flexure.
EEG-Derived Cortical Neural Activity
Time frame: During colonoscopy at predefined procedural stages, including anal intubation, splenic flexure, hepatic flexure, and ileocecal valve.
fNIRS-Derived HbO Cortical Activation
Time frame: During colonoscopy, at predefined procedural stages including anal intubation, splenic flexure, hepatic flexure, and cecal intubation, within the prespecified post-event analysis window for each stage.
fNIRS-Derived HbR Cortical Activation
Time frame: During colonoscopy, at predefined procedural stages including anal intubation, splenic flexure, hepatic flexure, and cecal intubation, within the prespecified post-event analysis window for each stage.
fNIRS-Derived Cortical Functional Connectivity
Time frame: During colonoscopy, at predefined procedural stages including anal intubation, splenic flexure, hepatic flexure, and cecal intubation.
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Derived from this study: PubMed 41033775Wang H, Huang X, Xu L, Guo S, Gong C, Mengcheng C, Wang W, Wang H, Fang F. Analysis of the analgesic mechanism of TENS-WAA in colonoscopy using the EEG-fNIRS system: a study protocol for a randomised controlled trial. BMJ Open. 2025 Sep 30;15(9):e103681. doi: 10.1136/bmjopen-2025-103681.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using an electrical stimulation device to relieve pain during colonoscopy in people with Colonoscopy and Pain, run by First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG-fNIRS Neurovascular Coupling Peak β Coefficient (time frame: During colonoscopy, at predefined procedural stages including anal intubation, splenic flexure, hepatic flexure, and cecal intubation, within the prespecified analysis window for each stage.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06813703, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.