Investigation of TVNS Administration on Postpartum Mental Health

NCT06682689 | Recruiting

• 1 other identifier: TUE/858/2023BO2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postpartum Depression (PPD); Postpartum Anxiety; Postpartum Sadness; Postpartum Blues

Keywords

tVNS; Transcutaneous vagus nerve stimulation; Postpartum; PPD; Depression

Outcome Measures

Primary Outcomes (2)

• tVNS-induced changes in postpartum depression symptoms

  To evaluate the effect of transcutaneous vagus nerve stimulation (tVNS) on depressive symptoms, as measured by the Edinburgh Postpartum Depression Scale (EPDS), which ranges from 0 to 30, with higher scores indicating more severe depressive symptoms. A standard cut-off score of 12-13 is typically used to indicate probable depressive symptoms. The total EPDS score will be assessed at multiple time points throughout the study, allowing for the comparison of changes in depressive symptom trajectories across conditions (tVNS vs. control). This design aims to capture differences in the development and progression of depressive symptoms between groups over the course of pregnancy and postpartum.

  Measured during pregnancy (T1), 6 weeks after birth (T2), and 12 weeks after birth (T3)]

• tVNS-induced changes in the daily mood

  The study will track and analyze the daily trajectory of mood changes-both positive and negative-from a baseline period prior to the 6-week transcutaneous vagus nerve stimulation (tVNS) intervention and throughout the intervention period, with assessments concluding on the final day of the intervention. Daily mood changes and stability will be measured using the Positive and Negative Affect Schedule (PANAS), administered through app-based ecological momentary assessment (EMA). Each item on the PANAS is rated on a 5-point Likert scale, ranging from 1 ("gar nichts" / "not at all") to 5 ("äußerst" / "extremely"), with higher scores reflecting a greater intensity of the specified mood. Positive affect (PA) scores represent more positive mood states (higher scores indicating better mood), while negative affect (NA) scores indicate the severity of negative mood states (higher scores representing worse mood). The analysis will focus on identifying trends, patterns, and fluctuations in mood

  From the recruitment through first 12 weeks of postpartum period

Secondary Outcomes (8)

• Intervention acceptance analysis

  through study completion, an average of 6 months

• Heart-rate variability changes

  From the recruitment through first 12 weeks of postpartum period

• Subjective sleep quality changes

  through study completion, an average of 6 months

• Objective sleep quality

  through study completion, an average of 6 months

• Postpartum depression diagnosis (clinical threshold)

  From the birth of the child to the end of the study (12 weeks)

Study Arms (3)

High-low tVNS

EXPERIMENTAL

Participants in this group will be instructed to use the tVNS device every day for the first six weeks according to the manufacturer's guidelines, at an intensity where they can feel a tingling sensation but below the pain threshold. After six weeks (T2) of intervention, they will be asked to switch to a different protocol for the next six weeks, using the device at the lowest possible intensity. Additional instructions will be provided, and they will be informed that this stimulation uses different parameters set by the research team.

Device: transcutaneous vagus nerve stimulation

Low-high tVNS

ACTIVE COMPARATOR

Participants in this group will receive the inverted intervention, with the first six weeks of stimulation at the lowest possible intensity (0.1 mA) with the same instructions regarding duration of stimulations, followed by six weeks of high-intensity stimulation as instructed by the manufacturer.

Device: transcutaneous vagus nerve stimulation

No tVNS

NO INTERVENTION

This group of participants will be included in all measurements (T1-T3) and check-ups, except for the tVNS stimulation.

Interventions

transcutaneous vagus nerve stimulation DEVICE

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.

High-low tVNS; Low-high tVNS

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• German Center for Mental Health (DZPG): collaborator

Study Sites (1)

University Hospital Tuebingen; Department of Psychiatry and Psychotherapy

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum; Depression

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Birgit Derntl, Prof., PhD

  University Hospital Tübingen

  PRINCIPAL INVESTIGATOR

• Nils Kroemer, Prof., Dr. rer. nat.

  University Hospital Tübingen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Siodmiak, M.sc.

CONTACT

+49 (0)7071 29-85736; julia.siodmiak@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 12, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be open to access after the analysis and publication by the study officials.
• Access Criteria: The protocols, plans, and codes and IPD will be shared via open-access platforms and linked to the publication. Specific data not available online will be provided upon request by one of the corresponding authors.

Locations

DE (1)