Evaluating the Impact of Transcranial Direct Current Stimulation on Urge in Body-Focused Repetitive Behaviors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Change in subjective urge
研究概览
简要总结
The goal of this study is to find out if brain stimulation can help people stop skin-picking or nail-biting. The study wants to answer two main questions:
- Does brain stimulation reduce the urge to pick skin or bite nails after those urges are triggered?
- Does brain stimulation reduce how often people pick their skin or bite their nails?
Participants will:
- Talk about their skin-picking, nail-biting, and other mental health concerns
- Be placed in situations that make them want to pick or bite
- Rate how strong their urges are before and after brain stimulation Researchers will compare real brain stimulation to a placebo (a fake version that looks the same but has no effect) to see if the real stimulation works to reduce skin-picking and nail-biting urges and behaviors.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide informed consent (as established by clinical interview), and voluntary, signed informed consent prior to the performance of any study specific
- •Ability and willingness to perform study-relevant clinical assessments and tDCS
- •Endorses mild to extreme intensity of urges to pick or bite their skin or nails
排除标准
- •Any unstable medical, psychiatric, or neurological condition (including active or otherwise problematic suicidality) that may necessitate urgent treatment
- •Daily use of psychotropic medications that substantially lower seizure threshold (e.g., clozapine)
- •History of psychosis, mania, major neurological disorder, significant head trauma, or seizures/epilepsy
- •Current suicidal intent
- •Any major neurological disease or history of major head trauma, including concussion with extended loss of consciousness, or of psychosurgery
- •Current or suspected pregnancy
- •Endorsing possible contraindications for tDCS
研究组 & 干预措施
active multifocal Transcranial Direct Current Stimulation (tDCS)
participants receive 13-min of active multifocal tDCS targeting the left dorsolateral prefrontal cortex. tDCS will be delivered offline for 13 minutes (1.5mA, 10 seconds ramp in/out).
干预措施: Wireless Multichannel Transcranial Current Stimulator (tDCS) (Device)
active multifocal Transcranial Direct Current Stimulation (tDCS)
participants receive 13-min of active multifocal tDCS targeting the left dorsolateral prefrontal cortex. tDCS will be delivered offline for 13 minutes (1.5mA, 10 seconds ramp in/out).
干预措施: Cue exposure (Behavioral)
active multifocal Transcranial Direct Current Stimulation (tDCS)
participants receive 13-min of active multifocal tDCS targeting the left dorsolateral prefrontal cortex. tDCS will be delivered offline for 13 minutes (1.5mA, 10 seconds ramp in/out).
干预措施: Boredom induction (Behavioral)
sham multifocal Transcranial Direct Current Stimulation (tDCS)
Sham stimulation will be identical to active but electrical current will only be ramped in/out at the beginning and end of the 13-min period.
干预措施: Wireless Multichannel Transcranial Current Stimulator (tDCS) (Device)
sham multifocal Transcranial Direct Current Stimulation (tDCS)
Sham stimulation will be identical to active but electrical current will only be ramped in/out at the beginning and end of the 13-min period.
干预措施: Cue exposure (Behavioral)
sham multifocal Transcranial Direct Current Stimulation (tDCS)
Sham stimulation will be identical to active but electrical current will only be ramped in/out at the beginning and end of the 13-min period.
干预措施: Boredom induction (Behavioral)
结局指标
主要结局
Change in subjective urge
时间窗: baseline and post intervention, approximately 90 minutes
Individuals will rate their urge to pick using a scale (1-10) with a higher score meaning greater urge. They will rate their urge three times in a row, at two different time-points.
Change in subjective distress
时间窗: baseline and post intervention, approximately 90 minutes
Individuals will rate their distress using a scale (1-10) with a higher score meaning greater distress. They will rate their distress three times in a row, at two different time-points.
Change in picking or biting behavioral frequency
时间窗: baseline and post intervention (approximately 90 minutes)
Picking or biting behaviors will be assessed via two 6-minute blocks of visual observation, before and after tDCS. The frequency of the behaviors observed will be collected in each block. Change in total frequency between blocks will be calculated.
Change in picking or biting behaviors duration
时间窗: baseline and post intervention (approximately 90 minutes)
Picking or biting behaviors will be assessed via two 6-minute blocks of visual observation, before and after tDCS. Duration of the behaviors observed will be collected in each block. Change in total duration between blocks will be calculated.
次要结局
未报告次要终点
研究者
Gopalkumar Rakesh
Assistant Professor
University of Kentucky