An interventional study of Transcutaneous vagus nerve stimulation (tVNS) and Sham transcutaneous vagus nerve stimulation (Sham tVNS) in Borderline Personality Disorder, sponsored by Sahlgrenska University Hospital. Recruiting at 1 site in Sweden. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-12-01.
Sponsored by Sahlgrenska University Hospital · Not applicable, Interventional, and Treatment
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:
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.
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:
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.
336 studies on the registry are indexed under Personality Disorders; 48 are open to participants now.
This study's planned enrollment of 42 is below the median of 75 across 229 interventional studies indexed under Personality Disorders.
Browse Personality Disorders studies →Sahlgrenska University Hospital is the lead sponsor of 259 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1 tVNS session of ca 45 minutes The electrodes are placed at the left ear concha. The ear concha is principally innerved by the afferent branch of the vagus nerve
Device: Transcutaneous vagus nerve stimulation (tVNS)
1 sham tVNS session of ca 45 minutes The electrodes are attached to the center of the left ear lobe, which is known to be free of cutaneous vagal innervation
Device: Sham transcutaneous vagus nerve stimulation (Sham tVNS)
The electrodes are placed at the left ear concha. The ear concha is principally innerved by the afferent branch of the vagus nerve
Also known as: Transcutaneous auricular vagus nerve stimulation (taVNS)
The electrodes are attached to the center of the left ear lobe, which is known to be free of cutaneous vagal innervation
Also known as: Sham Transcutaneous auricular vagus nerve stimulation (Sham taVNS)
Change in negative emotional arousal from baseline at immediately after affect-induction (post-induction ratings) as assessed by PANAS
The emotional arousal will be measured through the self-reported ratings of negative emotions on the PANAS (PANAS-N). The scale uses adjectives that describe mood states rather than discrete emotions and are rated from 1 = very slightly or not at all to 5 = extremely.
Time frame: Baseline and immediately after every of the four videos.
Change in negative emotional arousal from baseline at prior to affect-induction (pre-induction ratings) as assessed by PANAS
The emotional arousal will be measured through the self-reported ratings of negative emotions on the PANAS (PANAS-N). The scale uses adjectives that describe mood states rather than discrete emotions and are rated from 1 = very slightly or not at all to 5 = extremely.
Time frame: Baseline and 4 minutes after the tVNS/sham tVNS has begun, before the affect induction procedure.
Change in negative emotional arousal from immediately after affect-induction at 4 minutes after affect induction (recovery ratings) as assessed by PANAS
The emotional arousal will be measured through the self-reported ratings of negative emotions on the PANAS (PANAS-N). The scale uses adjectives that describe mood states rather than discrete emotions and are rated from 1 = very slightly or not at all to 5 = extremely.
Time frame: Immediately after and at 4 minutes after every of the three affect inducing videos
Perceived effectiveness in managing emotions (PEME) during affect induction.
Participants will be asked during the post-induction period about their perceived effectiveness in managing their emotions (PEME) by asking them to rate "How difficult was it to manage your emotional response to this film clip?" from 1 = not at all to 9 = extremely. This scale will be interpreted as a subjective difficulty in regulating emotions in response to each video stimulus.
Time frame: Immediately after every of the four videos
Plan to share: No — This will be discussed if the occasion arises in order to follow GDPR rules
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Sahlgrenska University Hospital