Investigation of TVNS Administration on Postpartum Mental Health
Integrative Investigation of Transcutaneous Vagus Nerve Stimulation: Impact on Postpartum Mental Health Through Wearable Technology, Hormonal Analysis and Modulatory Factors
University Hospital Tuebingen
120 participants
Nov 1, 2024
INTERVENTIONAL
Conditions
Summary
The aim of the study is to explore whether transcutaneous vagus nerve stimulation (tVNS) may be effective in preventing mood swings and depressive symptoms in the postpartum phase, as well as serving as a supplementary intervention in cases where mood symptoms develop. The study will investigate the effects of tVNS intervention during the first 12 weeks postpartum. Pregnant women will be recruited for the study, and the intervention will begin shortly after giving birth. Participants will receive different instructions on how to use the tVNS device. Additional parameters such as physiological functions, chronic stress, hormones, environment, and personality traits will also be assessed.
Eligibility
Inclusion Criteria3
- No malformation of fetal organs (no abnormalities detected during "organ screening").
- Ability to provide written consent for themselves.
- Sufficient German language skills to communicate and understand study procedures.
Exclusion Criteria6
- Cardiac arrhythmias or coronary heart disease.
- Neurological disorders.
- Current diagnosis or episode of a mood disorder.
- Diagnosed schizophrenia spectrum and other psychotic disorders.
- Severe substance use disorders.
- Individual exclusion may also occur based on other health issues if the study clinician determines that participation in the study may pose a disadvantage for the participant or the child.
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06682689