Using transcutaneous vagus nerve stimulation to help with borderline personality disorder
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
NA · Sahlgrenska University Hospital · NCT05892900
This study is testing whether a treatment using transcutaneous vagus nerve stimulation can help people with borderline personality disorder better manage their emotions.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Sahlgrenska University Hospital (other) |
| Locations | 1 site (Göteborg, Västra Götaland) |
| Trial ID | NCT05892900 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of transcutaneous vagus nerve stimulation (tVNS) in reducing emotional reactivity in individuals with borderline personality disorder (BPD). Participants will be randomly assigned to receive either tVNS or a sham treatment while watching a series of videos designed to induce emotional responses. After each video, participants will rate their emotions to assess the impact of the treatment on emotional regulation and recovery. The study seeks to determine if tVNS can significantly improve emotional management in those affected by BPD.
Who should consider this trial
Good fit: Ideal candidates for this study are Swedish-speaking females aged 18 to 50 with a current diagnosis of borderline personality disorder.
Not a fit: Patients with unstable medical or neurological conditions, or those currently pregnant, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, non-invasive option for managing emotional dysregulation in patients with borderline personality disorder.
How similar studies have performed: While the use of tVNS is a relatively novel approach, preliminary studies have shown promise in similar applications for emotional regulation.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Göteborg, Västra Götaland
- Giuseppe Guerriero — Göteborg, Västra Götaland, Sweden (RECRUITING)
Study contacts
- Study coordinator: Giuseppe Guerriero, MD, MSc
- Email: giuseppe.guerriero@vgregion.se
- Phone: +46700823616
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Borderline Personality Disorder, transcutaneous vagus nerve stimulation, borderline personality disorder, emotional vulnerability, emotion regulation