- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Wei
- Telefonnummer:  +86 13810678936
- E-post: changwei.wei@ccmu.edu.cn
Studiesteder
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Beijing, Kina
- Rekruttering
- Affiliated Beijing Chaoyang Hospital of Capital Medical University, Beijing 100020
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Ta kontakt med:
- Wei
- Telefonnummer:  +86 13810678936
- E-post: changwei.wei@ccmu.edu.cn
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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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Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Ingen inngripen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Electroencephalogram analysis
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Patients' VAS score
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026-ke-49
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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