Transcutaneous Vagus Nerve Stimulation (tVNS) for Borderline Personality Disorder (tVNS-BPD)
NCT ID: NCT05892900
Last Updated: 2023-12-01
Study Results
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Basic Information
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RECRUITING
NA
42 participants
INTERVENTIONAL
2023-03-24
2025-12-31
Brief Summary
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• 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
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* 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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
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
Sham 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
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
Interventions
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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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
50 Years
FEMALE
No
Sponsors
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Sahlgrenska University Hospital
OTHER
Responsible Party
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Giuseppe Guerriero
Principal Investigator
Principal Investigators
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Steinn Steingrimsson, MD, PhD
Role: STUDY_CHAIR
Sahlgrenska University Hospital
Locations
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Giuseppe Guerriero
Gothenburg, Västra Götaland County, Sweden
Countries
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Central Contacts
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Facility Contacts
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Giuseppe Guerriero, MD, MSc
Role: primary
Steinn Steingrimsson, MD, PhD
Role: backup
References
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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.
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
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.
Other Identifiers
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SU-971761
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CIVID:22-10-041068
Identifier Type: REGISTRY
Identifier Source: secondary_id
tVNS-BPD-001
Identifier Type: -
Identifier Source: org_study_id