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Safety and Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation on Patients with Depersonalization-Derealization Disorder: A Randomized Controlled Trial Study Protocol

Safety and Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation on Patients with Depersonalization-Derealization Disorder: A Randomized Controlled Trial Study Protocol

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078183
Enrollment
Unknown
Registered
2023-11-30
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-12-03

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

Conditions

Depersonalization-derealization disorder

Interventions

Test group:The electronic acupuncture instrument was used in this study to stimulate the vagus nerve through ear acupuncture. The auricular and earlobe areas of both ears were stimulated by the elect
current of =50mA (500O load impedance), using an intensity that was painless.
Control group:The electronic acupuncture instrument was used in this study to stimulate the vagus nerve through ear acupuncture. The auricular and earlobe areas of both ears were stimulated by the el

Sponsors

Beijing Anding Hospital affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: (1) Patients diagnosed with depersonalization disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), a score greater than 70 on the Cambridge Depersonalization Scale (CDS); (2) Age between 18 and 40 years old (inclusive ); (3) Comprehension of follow-up questionnaire survey; (4) No use of antipsychotic medication or the types and dosage of drugs were stable for 6 weeks, and did not receive acupuncture treatment ; (5) Able and willing to complete data collection through magnetic resonance imaging; and (6) Signed informed consent form and follow the research plan.

Exclusion criteria

Exclusion criteria: (1)Meet DSM-5 diagnostic criteria for other mental diseases except depersonalization disorder, such as schizophrenia, bipolar disorder, depression disorder, panic disorder, acute stress disorder, post-traumatic stress disorder or other separation disorders;(2) Severe or unstable physical disease; (3) Comorbid neurological disorders;(4) High risk of self-harm or suicide; (5) Pregnancy or lactation; (6) Contraindications to magnetic resonance imaging examination;(7) Need to take other psychotropic drugs besides the regulations during the study.

Design outcomes

Primary

MeasureTime frame
The change in the CDS score during the six-week treatment period;

Secondary

MeasureTime frame
Changes in HAMA and HAMD Scores at Each Visit During the 6-Week Treatment Period;Changes in Various Cognitive Function Indicators at Each Visit During the 6-Week Treatment Period;Changes in GAF, Q-LES-QSF, and WHOQOL-BREF Scores at Each Visit During the 6-Week Treatment Period;Changes in rs-fMRI Data Before and After the 6-Week Treatment Period;Changes in Safety Evaluation Indicators at Each Visit During the 6-Week;

Countries

China

Contacts

Public ContactZhao Yan

Beijing Anding Hospital affiliated to Capital Medical University

zhaoyandoc@foxmail.com+86 138 1058 1795

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026