Transcutaneous Vagus Nerve Stimulation (tVNS) for Borderline Personality Disorder (tVNS-BPD)

NCT05892900 | Unknown DMC

• 3 other identifiers: tVNS-BPD-001SU-971761CIVID:22-10-041068
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Borderline Personality Disorder

Keywords

transcutaneous vagus nerve stimulation; borderline personality disorder; emotional vulnerability; emotion regulation

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• Change in negative emotional arousal from baseline at prior to affect-induction (pre-induction ratings) as assessed by PANAS

  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

  Immediately after and at 4 minutes after every of the three affect inducing videos

• Perceived effectiveness in managing emotions (PEME) during affect induction.

  Immediately after every of the four videos

Study Arms (2)

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

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

Device: Sham transcutaneous vagus nerve stimulation (Sham tVNS)

Interventions

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

Also known as: Transcutaneous auricular vagus nerve stimulation (taVNS)

Transcutaneous vagus nerve stimulation (tVNS)

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

Also known as: Sham Transcutaneous auricular vagus nerve stimulation (Sham taVNS)

Sham Transcutaneous vagus nerve stimulation (tVNS)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Giuseppe Guerriero

Gothenburg, Västra Götaland County, 41345, Sweden

RECRUITING

Related Publications (3)

• 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.

  PMID: 29999393 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

  BACKGROUND

• 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.

  PMID: 38898522 DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder; Emotional Regulation

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• Steinn Steingrimsson, MD, PhD

  Sahlgrenska University Hospital

  STUDY CHAIR

Central Study Contacts

Giuseppe Guerriero, MD, MSc

CONTACT

+46700823616; giuseppe.guerriero@vgregion.se

Steinn Steingrimsson, MD, PhD

CONTACT

+46722448372; steinn.steingrimsson@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: June 7, 2023
• Study Start: March 24, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)