NCT05892900

Transcutaneous Vagus Nerve Stimulation (tVNS) for Borderline Personality Disorder (tVNS-BPD)

Transcutaneous Vagus Nerve Stimulation (tVNS) to Acutely Reduce Emotional Vulnerability and Improve Emotional Regulation in Borderline Personality Disorder (tVNS-BPD): a Randomized, Single-blind, Sham-controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Sahlgrenska University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to test the efficacy of transcutaneous vagus nerve stimulation (tVNS) in borderline personality disorder. The main question it aims to answer is: • Is tVNS effective in acutely reducing emotional reactivity in borderline personality disorder? Participants will be randomized to a single session of tVNS or sham-tVNS while going through an affect-inducing procedure. It will consist of the presentation of one neutral and three negative affect-inducing videos in sequence, each of which is followed by a post-induction period during which participants will rate the quality and intensity of their current self-reported emotions. Researchers will compare the tVNS and sham tVNS groups to see if there is a difference in the intensity of the self-reported emotions between the groups.

Detailed description

The study will be a randomized, single-blind, sham-controlled trial. The goal of this clinical trial is to test the efficacy of transcutaneous vagus nerve stimulation (tVNS) acutely reduce emotional vulnerability and improve emotional regulation in borderline personality disorder. The main questions it aims to answer are: * Is tVNS effective in acutely reducing emotional reactivity in borderline personality disorder? * Is tVNS effective in acutely reducing baseline emotional arousal in borderline personality disorder? * Is tVNS effective in acutely ease emotional recovery in borderline personality disorder? * Is tVNS effective in acutely improve emotional regulation in borderline personality disorder? The participants will be randomized to a single session of tVNS or sham-tVNS while going through an affect induction procedure. It will consist of the presentation of one neutral and three negative affect-evoking 4-minutes-long videos in sequence, each of which is followed by a 4-minutes post-induction period during which participants will rate the quality and intensity of their current self-reported emotions (post-induction ratings) and the perceived effectiveness in managing their emotions during the video presentation. The rating of the current self-reported emotions will be repeated after every post-induction period (recovery ratings). To test the difference in negative emotional arousal at every stage and the perceived effectiveness in managing emotions between the tVNS and sham tVNS groups, mixed models with individuals as random effects will be used. These models will take into account the repeated measurements of the same individuals at baseline, pre-induction, post-induction, and recovery.

Conditions

• Borderline Personality Disorder

Interventions

Type	Name	Description
DEVICE	Transcutaneous vagus nerve stimulation (tVNS)	The electrodes are placed at the left ear concha. The ear concha is principally innerved by the afferent branch of the vagus nerve
DEVICE	Sham transcutaneous vagus nerve stimulation (Sham tVNS)	The electrodes are attached to the center of the left ear lobe, which is known to be free of cutaneous vagal innervation

Timeline

• Start date: 2023-03-24
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2023-06-07
• Last updated: 2023-12-01

Locations

1 site across 1 country: Sweden