A clinical trial is currently in progress to investigate the potential of transcutaneous auricular vagus nerve stimulation (taVNS) as a treatment for depersonalization-derealization disorder (DPD). The study, designed as a randomized, double-blind, sham-controlled trial, aims to evaluate both the safety and effectiveness of taVNS in alleviating symptoms associated with DPD.
Trial Design and Objectives
The trial involves a six-week intervention period during which participants receive either active taVNS or a sham stimulation. The primary objective is to determine whether taVNS can significantly reduce depersonalization symptoms in patients with DPD. Secondary endpoints include assessing changes in anxiety and depression levels, cognitive and social functioning, and alterations in brain activity as measured by functional magnetic resonance imaging (fMRI).
Methodology and Assessments
Participants will undergo comprehensive assessments at baseline and after the six-week treatment period. These assessments include:
- Symptom Evaluation: The Cambridge Depersonalization Scale (CDS) will be used to evaluate depersonalization symptoms, while the Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD) will assess anxiety and depression symptoms.
- Cognitive Function Assessment: The MATRICS Consensus Cognitive Battery (MCCB) will be employed to evaluate various cognitive domains, including information processing speed, word learning ability, visual memory, attention/alertness, and attention inhibition.
- Social Function Assessment: The Global Assessment Function (GAF) and the Short Form of Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-QSF) will be used to assess social function, happiness, life quality, and satisfaction. The World Health Organization Quality of Life – BREF (WHOQOL-BREF) will comprehensively evaluate their quality of life and satisfaction.
- fMRI: Resting-state fMRI will be utilized to extract the brain’s spontaneous activity, static and dynamic functional connections, and functional network properties that reflect the brain’s functional state.
Safety Measures and Data Management
Safety is a paramount concern in this trial. Participants will undergo regular safety assessments, including physical examinations, vital sign monitoring, blood and urine routine tests, biochemistry analyses, and electrocardiograms. The trial has strict termination protocols in place should significant safety issues arise or if the treatment demonstrates insufficient therapeutic effects.
Data management protocols are rigorous, with research personnel undergoing comprehensive training on case report form (CRF) completion and scale scoring. Dual data entry using EpiData software will be implemented to ensure data accuracy. Patient confidentiality is maintained through the assignment of unique codes, with the statistics team only having access to de-identified data.
Future Analyses
Blood samples collected during the study will be stored in the biobank of Beijing Anding Hospital for future safety and mechanistic analyses, potentially providing further insights into the biological underpinnings of DPD and the mechanisms of action of taVNS.
