Investigation of TVNS Administration on Postpartum Mental Health

NARecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

November 30, 2024

Primary Completion Date

September 30, 2026

Study Completion Date

December 31, 2026

Conditions
Postpartum Depression (PPD)Postpartum AnxietyPostpartum SadnessPostpartum Blues
Interventions
DEVICE

transcutaneous vagus nerve stimulation

Two groups will use a tVNS stimulator for 12 weeks. Group 1 will apply active stimulation for up to 4 hours daily at a comfortable level for 6 weeks, while Group 2 will use it at the lowest intensity (0.1 mA). After 6 weeks (T2), the groups will switch. Participants will be instructed to use the device for at least 1 hour a day, with a recommendation of 4 hours, following guidelines and recent studies. The CE-certified tVNS® E device non-invasively stimulates the vagus nerve via the ear. It is approved for treating a.o.depression. Device parameters (intensity, pulse length, frequency) mimic invasive VNS techniques, ensuring safe and effective signal transmission. Stimulation will be applied to the left ear, with intensity adjusted to a tingling sensation, avoiding discomfort. The study follows an approved protocol, with low-intensity stimulation as a control. The device delivers biphasic impulses at 25 Hz, with 28 seconds ON and 32 seconds OFF, and is safe for extended use.

Trial Locations (1)

72076

RECRUITING

University Hospital Tuebingen; Department of Psychiatry and Psychotherapy, Tübingen

All Listed Sponsors
collaborator

German Center for Mental Health (DZPG)

UNKNOWN

lead

University Hospital Tuebingen

OTHER