Back to resultsTranscutaneous Vagus Nerve Stimulation (tVNS) for Borderline Personality Disorder (tVNS-BPD) (tVNS-BPD)
Primary Purpose
Borderline Personality Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Transcutaneous vagus nerve stimulation (tVNS)
Sham transcutaneous vagus nerve stimulation (Sham tVNS)
Sponsored by
About this trial
This is an interventional treatment trial for Borderline Personality Disorder focused on measuring transcutaneous vagus nerve stimulation, borderline personality disorder, emotional vulnerability, emotion regulation
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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) 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).
Sites / Locations
- Giuseppe GuerrieroRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Transcutaneous vagus nerve stimulation (tVNS)
Sham Transcutaneous vagus nerve stimulation (tVNS)
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05892900
First Posted
May 18, 2023
Last Updated
May 28, 2023
Sponsor
Sahlgrenska University Hospital, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT05892900
Brief Title
Transcutaneous Vagus Nerve Stimulation (tVNS) for Borderline Personality Disorder (tVNS-BPD)
Acronym
tVNS-BPD
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 24, 2023 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
transcutaneous vagus nerve stimulation, borderline personality disorder, emotional vulnerability, emotion regulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transcutaneous vagus nerve stimulation (tVNS)
Arm Type
Experimental
Arm Description
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
Arm Title
Sham Transcutaneous vagus nerve stimulation (tVNS)
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Transcutaneous vagus nerve stimulation (tVNS)
Other Intervention Name(s)
Transcutaneous auricular vagus nerve stimulation (taVNS)
Intervention Description
The electrodes are placed at the left ear concha. The ear concha is principally innerved by the afferent branch of the vagus nerve
Intervention Type
Device
Intervention Name(s)
Sham transcutaneous vagus nerve stimulation (Sham tVNS)
Other Intervention Name(s)
Sham Transcutaneous auricular vagus nerve stimulation (Sham taVNS)
Intervention Description
The electrodes are attached to the center of the left ear lobe, which is known to be free of cutaneous vagal innervation
Primary Outcome Measure Information:
Title
Change in negative emotional arousal from baseline at immediately after affect-induction (post-induction ratings) as assessed by PANAS
Description
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.
Secondary Outcome Measure Information:
Title
Change in negative emotional arousal from baseline at prior to affect-induction (pre-induction ratings) as assessed by PANAS
Description
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.
Title
Change in negative emotional arousal from immediately after affect-induction at 4 minutes after affect induction (recovery ratings) as assessed by PANAS
Description
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
Title
Perceived effectiveness in managing emotions (PEME) during affect induction.
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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)
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giuseppe Guerriero, MD, MSc
Phone
+46700823616
Email
giuseppe.guerriero@vgregion.se
First Name & Middle Initial & Last Name or Official Title & Degree
Steinn Steingrimsson, MD, PhD
Phone
+46722448372
Email
steinn.steingrimsson@vgregion.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steinn Steingrimsson, MD, PhD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Study Chair
Facility Information:
Facility Name
Giuseppe Guerriero
City
Göteborg
State/Province
Västra Götaland
ZIP/Postal Code
41345
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Guerriero, MD, MSc
Phone
+46700823616
Email
giuseppe.guerriero@vgregion.se
First Name & Middle Initial & Last Name & Degree
Steinn Steingrimsson, MD, PhD
Phone
+46722448372
Email
steinn.steingrimsson@vgregion.se
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
This will be discussed if the occasion arises in order to follow GDPR rules
Citations:
PubMed Identifier
29999393
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
Learn more about this trial
Transcutaneous Vagus Nerve Stimulation (tVNS) for Borderline Personality Disorder (tVNS-BPD)
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