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| ID | Type | Description | Link |
|---|---|---|---|
| SU-971761 | Other Grant/Funding Number | Sahlgrenska University Hospital | |
| CIVID:22-10-041068 | Registry Identifier | Swedish Medical Products Agency (Läkemedelsverket) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous vagus nerve stimulation (tVNS) | Experimental | 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 |
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| Sham Transcutaneous vagus nerve stimulation (tVNS) | Sham Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous vagus nerve stimulation (tVNS) | Device | The electrodes are placed at the left ear concha. The ear concha is principally innerved by the afferent branch of the vagus nerve |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and immediately after every of the four videos. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 4 minutes after the tVNS/sham tVNS has begun, before the affect induction procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giuseppe Guerriero, MD, MSc | Contact | +46700823616 | giuseppe.guerriero@vgregion.se | |
| Steinn Steingrimsson, MD, PhD | Contact | +46722448372 | steinn.steingrimsson@vgregion.se |
| Name | Affiliation | Role |
|---|---|---|
| Steinn Steingrimsson, MD, PhD | Sahlgrenska University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Giuseppe Guerriero | Recruiting | Gothenburg | Västra Götaland County | 41345 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29999393 | Background | Daros AR, Williams GE, Jung S, Turabi M, Uliaszek AA, Ruocco AC. More is not always better: Strategies to regulate negative mood induction in women with borderline personality disorder and depressive and anxiety disorders. Personal Disord. 2018 Nov;9(6):530-542. doi: 10.1037/per0000296. Epub 2018 Jul 12. | |
| Background | Guerriero G, Wartenberg C, Bernhardsson S, Gunnarsson S, Ioannou M, Liljedahl SI, et al. Efficacy of transcutaneous vagus nerve stimulation as treatment for depression: A systematic review. J Affect Disord Rep. 2021 Dec 1;6:100233. https://doi.org/10.1016/j.jadr.2021.100233 | ||
| 38898522 |
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This will be discussed if the occasion arises in order to follow GDPR rules
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| ID | Term |
|---|---|
| D001883 | Borderline Personality Disorder |
| D000080103 | Emotional Regulation |
| ID | Term |
|---|---|
| D010554 | Personality Disorders |
| D001523 | Mental Disorders |
| D000068356 | Self-Control |
| D012919 | Social Behavior |
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| Sham transcutaneous vagus nerve stimulation (Sham tVNS) | Device | The electrodes are attached to the center of the left ear lobe, which is known to be free of cutaneous vagal innervation |
|
|
| 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. | 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. | Immediately after every of the four videos |
| Derived |
| Guerriero G, Liljedahl SI, Carlsen HK, Lopez Munoz M, Daros AR, Ruocco AC, Steingrimsson S. Transcutaneous auricular vagus nerve stimulation to acutely reduce emotional vulnerability and improve emotional regulation in borderline personality disorder (tVNS-BPD): study protocol for a randomized, single-blind, sham-controlled trial. Trials. 2024 Jun 19;25(1):397. doi: 10.1186/s13063-024-08230-6. |
| D001519 |
| Behavior |