Borderline Personality DisordertVNS-BPDNCT05892900
Transcutaneous Vagus Nerve Stimulation (tVNS) for Borderline Personality Disorder (tVNS-BPD)
A study testing Transcutaneous vagus nerve stimulation (tVNS) in people with Borderline Personality Disorder, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Transcutaneous vagus nerve stimulation (tVNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteSweden
- Study dates
- 24 Mar 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Swedish-speaking and able to provide informed consent to participate in the study
- Female and between the ages 18 and 50 years old.
- Current DSM-5 (Diagnostic and statistical manual of mental disorder-5) diagnosis of BPD based on the Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD)
- Capable (in the Investigator's opinion) and willing to comply with all study requirements.
Who cannot join
- Any unstable medical and/or neurological condition
- Currently pregnant
- Any significant neurological disorder or condition likely to be associated with increased intracranial pressure or cognitive impairment (e.g., a space occupying brain lesion, a history of stroke, a cerebral aneurysm, a seizure disorder, Parkinson's disease, Huntington's chorea, multiple sclerosis)
- Current diagnosis of delirium, dementia or another cognitive disorder secondary to a general medical condition
- Established diagnosis of a developmental and neuropsychiatric disorder (e.g. Down syndrome, autism-spectrum disorder, ADHD)
- Non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the affect induction procedure, follow and answer the survey instructions and questions)
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- Alcohol or substance use disorder (relating to opioids, cocaine, amphetamine or benzodiazepine) currently or within the past 1 month
- Daily treatment with antiepileptics (e.g., carbamazepine, gabapentin, lamotrigine, levetiracetam, pregabalin, sodium valproate, topiramate) or benzodiazepines (last dose over 7 days before the screening)
- Alcohol or substance use disorder (relating to opioids or cocaine) currently or within the past 1 month
- Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
- History or diagnosis of bipolar or chronic psychotic disorder (e.g., schizophrenia, schizoaffective disorder).
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Giuseppe Guerriero
Gothenburg, Västra Götaland County, 41345
Giuseppe Guerriero, MD, MSc, +46700823616, giuseppe.guerriero@vgregion.se
Steinn Steingrimsson, MD, PhD, +46722448372, steinn.steingrimsson@vgregion.se
About this study
Official title: 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
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?
Read more
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.
Read the 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
- Being tested
- Transcutaneous vagus nerve stimulation (tVNS), Sham transcutaneous vagus nerve stimulation (Sham tVNS)
- Keywords
- transcutaneous vagus nerve stimulation, borderline personality disorder, emotional vulnerability, emotion regulation
- Medical subject headings
- Borderline Personality Disorder, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous vagus nerve stimulation (tVNS)Device
Also called Transcutaneous auricular vagus nerve stimulation (taVNS)
The electrodes are placed at the left ear concha. The ear concha is principally innerved by the afferent branch of the vagus nerve
Sham transcutaneous vagus nerve stimulation (Sham tVNS)Device
Also called Sham Transcutaneous auricular vagus nerve stimulation (Sham taVNS)
The electrodes are attached to the center of the left ear lobe, which is known to be free of cutaneous vagal innervation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Transcutaneous vagus nerve stimulation (tVNS) |
| 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 Receives: Device: Sham transcutaneous vagus nerve stimulation (Sham tVNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and immediately after every of the four videos.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Immediately after every of the four videos
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start24 Mar 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Guerriero, Sahlgrenska University Hospital
- Investigators
- Steinn Steingrimsson, MD, PhD, Study chair, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892900
- Sponsor's protocol ID
- tVNS-BPD-001
- Other IDs
- SU-971761, CIVID:22-10-041068
- Acronym
- tVNS-BPD
- Status last verified
- Nov 2023
- First submitted
- 18 May 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This will be discussed if the occasion arises in order to follow GDPR rules
Publications
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.
PubMed 29999393Guerriero 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
Guerriero G, Ruocco AC, Carlsen HK, Daros AR, Kosara D, Steingrimsson S. Transcutaneous auricular vagus nerve stimulation and emotional responding in borderline personality disorder: a randomized single-blind, sham-controlled study. Borderline Personal Disord Emot Dysregul. 2026 Aug 4;13(1):24. doi: 10.1186/s40479-026-00367-x.
PubMed 42547917Guerriero 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.
PubMed 38898522
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05892900
- Acronym / sponsor ID
- tVNS-BPD / tVNS-BPD-001
- Conditions
- Borderline Personality Disorder
- Keywords
- transcutaneous vagus nerve stimulation, borderline personality disorder, emotional vulnerability, emotion regulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 24 Mar 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous vagus nerve stimulation (tVNS) | Experimental | Device: Transcutaneous vagus nerve stimulation (tVNS)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 |
| Sham Transcutaneous vagus nerve stimulation (tVNS) | Sham comparator | Device: Sham transcutaneous vagus nerve stimulation (Sham 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Swedish-speaking and able to provide informed consent to participate in the study
- Female and between the ages 18 and 50 years old.
- Current DSM-5 (Diagnostic and statistical manual of mental disorder-5) diagnosis of BPD based on the Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD)
- Capable (in the Investigator's opinion) and willing to comply with all study requirements.
Key exclusion criteria (11 listed)
- Any unstable medical and/or neurological condition
- Currently pregnant
- Any significant neurological disorder or condition likely to be associated with increased intracranial pressure or cognitive impairment (e.g., a space occupying brain lesion, a history of stroke, a cerebral aneurysm, a seizure disorder, Parkinson's disease, Huntington's chorea, multiple sclerosis)
- Current diagnosis of delirium, dementia or another cognitive disorder secondary to a general medical condition
- Established diagnosis of a developmental and neuropsychiatric disorder (e.g. Down syndrome, autism-spectrum disorder, ADHD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous vagus nerve stimulation (tVNS)Also: Transcutaneous auricular vagus nerve stimulation (taVNS)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) |
| Sham transcutaneous vagus nerve stimulation (Sham tVNS)Also: Sham Transcutaneous auricular vagus nerve stimulation (Sham taVNS)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 (tVNS) |
Primary outcome
Change in negative emotional arousal from baseline at immediately after affect-induction (post-induction ratings) as assessed by PANAS
Time frame: Baseline and immediately after every of the four videos.
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.
3 secondary outcomes
Change in negative emotional arousal from baseline at prior to affect-induction (pre-induction ratings) as assessed by PANAS
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
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.
Time frame: Immediately after every of the four videos
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Background: PubMed 29999393Daros 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.
- BackgroundGuerriero 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
- Derived from this study: PubMed 42547917Guerriero G, Ruocco AC, Carlsen HK, Daros AR, Kosara D, Steingrimsson S. Transcutaneous auricular vagus nerve stimulation and emotional responding in borderline personality disorder: a randomized single-blind, sham-controlled study. Borderline Personal Disord Emot Dysregul. 2026 Aug 4;13(1):24. doi: 10.1186/s40479-026-00367-x.
- Derived from this study: PubMed 38898522Guerriero 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.
- Individual participant dataSharing planned: No. This will be discussed if the occasion arises in order to follow GDPR rules
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steinn Steingrimsson, MD, PhD study chair
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous vagus nerve stimulation (tVNS) in people with Borderline Personality Disorder, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Guerriero, MD, MSc (+46700823616, giuseppe.guerriero@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in negative emotional arousal from baseline at immediately after affect-induction (post-induction ratings) as assessed by PANAS (time frame: Baseline and immediately after every of the four videos.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05892900, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.