Investigation of the influence of transauricular vagus nerve stimulation (taVNS) on premenstrual dysphoric disorder

Investigation of the influence of transauricular vagus nerve stimulation (taVNS) on premenstrual dysphoric disorder - EVA-Stim

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00037853

Enrollment

Registered

2025-09-04

Start date

2026-07-01

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

F38.8 N94.3

Interventions

Group 1: Verum taVNS (active stimulation) Participants receive transcutaneous auricular vagus nerve stimulation (taVNS) on the left ear (cymba conchae) using a CE-certified device (tVNS Technologies G

Eligibility

Sex/Gender

Female

Age

20 Years to 42 Years

Inclusion criteria

Inclusion criteria: • Diagnosis of PMDD according to DSM-5 (SCID-PMDD) • Regular cycle between 23 and 34 days over the last 6 months

Exclusion criteria

Exclusion criteria: • Irregular cycle (> 5 days variation) • Hormonal medication or relevant gynecological pre-existing conditions (e.g., endometriosis, hysterectomy, oophorectomy) • Pregnancy or breastfeeding in the last 6 months • Previous psychiatric conditions (bipolar or psychotic disorders, current depression, panic disorder, generalized anxiety disorder, substance dependence, suicidal tendencies in the last 6 months) • Current psychotherapeutic treatment • Pacemakers, cochlear implants, chronic cardiovascular disease • Competitive athletes • Planned significant lifestyle changes during the study period

Design outcomes

Primary

Measure	Time frame
• Feasibility of the study design (recruitability, feasibility of daily taVNS/SPB application in the home environment, completeness and usability of the data collected).	—

Secondary

Measure	Time frame
• Change in PMDS symptoms over three menstrual cycles (symptom diary, psychometric scales). • Comparison of taVNS vs. SPB in terms of symptom reduction and physiological markers. • Changes in physiological parameters: activity, heart rate variability, microbiome, hair cortisol, pro- and anti-inflammatory cytokines, EEG alpha asymmetry. • Sustainability of effects (follow-up 1 cycle after end of intervention). • Identification of potential predictive markers for therapeutic success.	—

Measure

Time frame

• Change in PMDS symptoms over three menstrual cycles (symptom diary, psychometric scales). • Comparison of taVNS vs. SPB in terms of symptom reduction and physiological markers. • Changes in physiological parameters: activity, heart rate variability, microbiome, hair cortisol, pro- and anti-inflammatory cytokines, EEG alpha asymmetry. • Sustainability of effects (follow-up 1 cycle after end of intervention). • Identification of potential predictive markers for therapeutic success.

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Countries

Germany

Contacts

Public ContactMaria Kühne

Universitätsklinik für Neurologie

maria.kuehne@med.ovgu.de+49-391-67-14257

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026