- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07819630
Electroencephalogram Changes Induced by Transcutaneous Electrical Acupoint Stimulation
Randomized Controlled Trial on the Effects of Transcutaneous Electroacupuncture on Brain Functional Connectivity in Postoperative Pain Patients Based on Electroencephalography
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wei
- Phone Number:  +86 13810678936
- Email: changwei.wei@ccmu.edu.cn
Study Locations
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Beijing, China
- Recruiting
- Affiliated Beijing Chaoyang Hospital of Capital Medical University, Beijing 100020
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Contact:
- Wei
- Phone Number:  +86 13810678936
- Email: changwei.wei@ccmu.edu.cn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:1. Age between 18 and 80 years; 2. ASA physical status classification I-II; 3. Scheduled to undergo abdominal surgery under general anesthesia (e.g., gastrectomy, colorectal cancer surgery, etc.); 4. Consent to participate in the study and signing of the informed consent form.
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Exclusion Criteria:1. Impaired cognitive function or language communication disorders; 2. Mental disorders, epilepsy, or abnormal EEG activity; 3. Receipt of acupoint therapy within two weeks prior to surgery; 4. Presence of a cardiac pacemaker or metal implants; 5. Allergy to surface electrodes; 6. Concomitant medical conditions (e.g., dermatological disorders) that may affect treatment or trial administration.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Transcutaneous electrical acupoint stimulation group
Group description: Participants in the reorganization will receive TEAS stimulation at bilateral Neiguan, Hegu, and Zusanli acupoints, and EEG data will be collected throughout the entire process using a 32 lead EEG cap test.
During the experiment, changes in hemodynamic parameters (blood pressure, heart rate) and perioperative pain scores of the subjects will be recorded.
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Group description: Participants in this group will receive TEAS stimulation at the bilateral Neiguan, Hegu, and Zusanli acupoints 30 minutes before the start of the surgery, and their EEG data will be collected throughout the entire process using a 32 lead EEG cap test.
During the experiment, the changes in hemodynamic parameters (blood pressure, heart rate) of the subjects during surgery will be recorded, as well as the perioperative pain scores of the subjects at 1 hour and 24 hours after surgery.
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No Intervention: Control group
Attach electrodes to the same area but do not apply stimulation, while informing the patient that percutaneous acupoint electrical stimulation therapy has been performed
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Electroencephalogram analysis
Time Frame: Five - minute baseline EEG data with eyes closed during wakefulness;EEG data during pre - operative transcutaneous electrical acupoint stimulation;Immediate post - operative EEG data
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Changes in EEG in the experimental group with transcutaneous electrical acupoint stimulation compared to the baseline, as well as post - operative EEG changes in the experimental group and the control group.Including:node clustering coefficient,node efficiency,normalized mean clustering coefficient,normalized path length,modularity,small-world network
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Five - minute baseline EEG data with eyes closed during wakefulness;EEG data during pre - operative transcutaneous electrical acupoint stimulation;Immediate post - operative EEG data
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patients' VAS score
Time Frame: 24 hours after surgery
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Patients' VAS scores24 hours after surgery
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24 hours after surgery
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-ke-49
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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