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Study on the inflammatory cytokine mechanisms of transcutaneous electrical acupoint stimulation combined with transcutaneous auricular vagus nerve stimulation for negative symptoms of schizophrenia

Study on the inflammatory cytokine mechanisms of transcutaneous electrical acupoint stimulation combined with transcutaneous auricular vagus nerve stimulation for negative symptoms of schizophrenia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000212
Enrollment
Unknown
Registered
2026-01-28
Start date
2026-01-30
Completion date
Unknown
Last updated
2026-02-02

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) Diagnosed with schizophrenia according to DSM-5 criteria; (2) Aged 18-65 years; (3) Stable condition for at least 4 weeks prior to enrollment; (4) Received at least 4 weeks of stable-dose antipsychotic medication (excluding patients taking antidepressants) prior to enrollment, and maintained the same dose during the intervention period; (5) PANSS-FSNS (N1 emotional blunting, N2 emotional withdrawal, N3 communication difficulties, N4 passive/cold social withdrawal, N6 lack of spontaneity and fluency in conversation, G7 motor poverty, G16 active social avoidance) =24; (6) At least two of the three core negative symptom items scored =4 (N1, N4, N6); (7) Patient or family member agrees and signs the informed consent form. Note: Patients who meet all seven criteria above are eligible for inclusion in this study.

Exclusion criteria

Exclusion criteria: (1) PANSS-FSPS (P1 Delusions, P3 Hallucinatory Behavior, P5 Grandiosity, P6 Suspiciousness/Persecution, G9 Unusual Thought Content) > 19; (2) Two or more items in the PANSS-FSPS five-item scale score = 4; (3) Calgary Depression Scale for Schizophrenia (CDSS) total score > 6; (4) Alcohol or other substance dependence or addiction; (5) Concurrent depression, anxiety, obsessive-compulsive disorder, bipolar affective disorder, or other mental disorders; (6) History of epilepsy or other neurological diseases; (7) Suicidal tendencies or violent behavior; (8) Severe somatic diseases, including severe cardiovascular diseases, liver diseases, kidney diseases, or organic brain lesions; (9) Auricular deformities or other auricular disorders; (10) Antibiotic, anti-inflammatory, or hormone therapy within the past month; (11) Acute infectious or inflammatory diseases within the past 4 weeks, or concurrent chronic inflammatory diseases, autoimmune diseases, etc.; (12) Devices that may be affected by or affect TEAS/taVNS equipment, such as pacemakers, drug pumps, cochlear implants, or implanted brain stimulators; (13) Skin damage, infection, or other issues at the treatment site; (14) History of TEAS/taVNS treatment within the past 6 months; (15) Females who are pregnant, breastfeeding, planning pregnancy, or have given birth within the past 6 months. Note: Participants meeting any of the above criteria will be excluded.

Design outcomes

Primary

MeasureTime frame
Inflammatory cytokine;

Secondary

MeasureTime frame
Positive and Negative Syndrome Scale – Factored Structure Negative Symptoms(PANSS-FSNS);treatment response rate;Scale for the Assessment of Negative Symptoms(SANS);Positive and Negative Syndrome Scale – Factored Structure Positive Symptoms(PANSS-FSPS);Positive and Negative Syndrome Scale (PANSS);Calgary Depression Scale for Schizophrenia(CDSS);Clinical Global Impression – Severity scale(CGI-S);Compliance Evaluation;Adverse Event;Treatment Satisfaction;Blinded Assessment;

Countries

China

Contacts

Public ContactGong Yi

Kunming Psychiatric Hospital

13888629364@139.com13888629364

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 7, 2026