Exploring the effects of transcutaneous vagus nerve stimulation on postpartum mental health
Integrative Investigation of Transcutaneous Vagus Nerve Stimulation: Impact on Postpartum Mental Health Through Wearable Technology, Hormonal Analysis and Modulatory Factors
This study is testing if a new treatment using gentle electrical stimulation can help new moms avoid mood swings and depression after giving birth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital Tuebingen Academic / other |
| Locations | 1 site (Tübingen, Baden-Wurttemberg) |
| Trial ID | NCT06682689 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of transcutaneous vagus nerve stimulation (tVNS) in preventing mood swings and depressive symptoms in women during the postpartum phase. It employs a crossover design where participants receive either high-intensity tVNS, low-intensity tVNS, or no stimulation over a period of six weeks, followed by a switch in protocols. The study also assesses various factors such as physiological functions, chronic stress, hormones, and personality traits, alongside daily mood assessments and psychometric tests. Participants' partners may also contribute by providing insights into their mental health and support roles.
Who should consider this trial
Good fit: Ideal candidates are postpartum women who have recently given birth and meet the inclusion criteria.
Not a fit: Patients with active mood disorders or significant health issues that could complicate participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a non-invasive treatment option for managing postpartum mood disorders.
How similar studies have performed: While the use of tVNS is a novel approach in this context, similar studies have shown promise in other areas of mental health treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Exclusion criteria for tVNS use (i.e., pregnancy, active implants such as cochlear implants or cardiac pacemakers, cerebral shunts, skin problems, cardiovascular health issues). * 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.
Where this trial is running
Tübingen, Baden-Wurttemberg
- University Hospital Tuebingen; Department of Psychiatry and Psychotherapy — Tübingen, Baden-Wurttemberg, Germany (Recruiting)
Study contacts
- Principal investigator: Birgit Derntl, Prof., PhD — University Hospital Tübingen
- Study coordinator: Julia Siodmiak, M.sc.
- Email: julia.siodmiak@med.uni-tuebingen.de
- Phone: +49 (0)7071 29-85736
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.