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A Study on the Efficacy of Transcutaneous Electrical Acupoint Stimulation Combined with Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Negative Symptoms in Schizophrenia

A Study on the Efficacy of Transcutaneous Electrical Acupoint Stimulation Combined with Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Negative Symptoms in Schizophrenia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000634
Enrollment
Unknown
Registered
2025-04-02
Start date
2025-10-31
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

schizophrenia

Interventions

Sponsors

Kunming Psychiatric Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Diagnosis of schizophrenia according to DSM-5 criteria; 2.Aged 18–65 years; 3.Stable for at least 4 weeks prior to enrolment; 4.Received a stable dose of antipsychotic medication (excluding patients on antidepressants) for at least 4 weeks prior to enrolment and remained unchanged during the study period; 5.PANSS-FSNS (N1blunted affect N2emotional withdrawal N3poor rapport N4passive/apathetic social withdrawal N6lack of spontaneity and flow of conversation G7motor retardation G16active social avoidance)= 24; 6.At least two core negative symptom items scoring = 4 (N1 N4 N6); 7.Agree and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.PANSS-FSPS (P1Delusions P3 Hallucinatory Behavior P5Grandiosity P6Suspicion/Persecution G9Unusual Thought Content) > 19; 2.Two or more items on the PANSS-FSPS with scores = 4; 3.Total score on the Calgary Depression Scale for Schizophrenia (CDSS) > 6; 4.Alcohol or substance dependence or addiction; 5.Commorbid psychiatric disorders such as depression anxiety obsessive-compulsive disorder bipolar disorder etc; 6.History of neurological disorders such as epilepsy or related conditions;7.Suicidal tendencies or violent behavior; 8.Severe physical diseases including severe cardiovascular disease liver disease kidney disease brain organic lesions etc; 9.Auricular malformations and other auricular disorders; 10.Devices that may affect or be affected by TEAS/taVNS such as pacemakers drug pumps cochlear implants or implanted brain stimulators; 11.Treatment site skin allergies infections etc; 12.History of TEAS or taVNS treatment within the past six months; 13.Females who are preparing for pregnancy pregnant breastfeeding or have a history of giving birth within 6 months.

Design outcomes

Primary

MeasureTime frame
PANSS-Factor Score for Negative Symptoms;

Secondary

MeasureTime frame
SANS score;treatment response rate;wakefulness EEG and ECG;CDSS score;PANSS-Factor Score for Positive Symptoms;PANSS total score;PANSS-Factor Score for Negative Symptoms at other time points during the study;adverse event;compliance evaluation;CGI-S score;

Countries

China

Contacts

Public ContactGong Yi

Kunming Psychiatric Hospital

13888629364@139.com13888629364

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jul 18, 2026