Transcutaneous Vagus Nerve Stimulation (tVNS) for Borderline Personality Disorder (tVNS-BPD)
NCT05892900 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2023-12-01
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
Interventions
- DEVICE
-
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
- DEVICE
-
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
Sponsors & Collaborators
-
Sahlgrenska University Hospital
lead OTHER
Principal Investigators
-
Steinn Steingrimsson, MD, PhD · Sahlgrenska University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-24
- Primary Completion
- 2024-12-31
- Completion
- 2025-12-31
Countries
- Sweden
Study Locations
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