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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change in negative emotional arousal from baseline at immediately after affect-induction (post-induction ratings) as assessed by PANAS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Change in negative emotional arousal from baseline at immediately after affect-induction (post-induction ratings) as assessed by PANAS
时间窗: Baseline and immediately after every of the four videos.
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.
次要结局
- 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.)
- Perceived effectiveness in managing emotions (PEME) during affect induction.(Immediately after every of the four videos)
- 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)
研究者
Giuseppe Guerriero
Principal Investigator
Sahlgrenska University Hospital, Sweden