tDCS and Urge in BFRBs

Официальное название

Evaluating the Impact of Transcranial Direct Current Stimulation on Urge in Body-Focused Repetitive Behaviors

Обзор

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: 1. Does brain stimulation reduce the urge to pick skin or bite nails after those urges are triggered? 2. 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.

Вмешательства

• Устройство Wireless Multichannel Transcranial Current Stimulator (tDCS)
  tDCS will be delivered for 13 minutes (active) or only at the beginning and end of the 13 minute period (sham) using Neuroelectrics Instrument Controller software and a battery-driven Starstim 8-channel transcranial direct current stimulator with 1cm2 ceramic electrodes and SIGNAGEL conductive saline gel.
• Поведенческое Cue exposure
  Participants will undergo three, twenty-second trials of exposure to individualized cues at the top of the established urge hierarchy, previously determined to precede picking or biting behaviors before and after tDCS.
• Поведенческое Boredom induction
  Participants will be left in the testing room without access to a cellphone or reading materials for 2 different 6 minute periods.

Первичные конечные точки

• Change in subjective urge [Срок оценки: baseline and post intervention, approximately 90 minutes]
• Change in subjective distress [Срок оценки: baseline and post intervention, approximately 90 minutes]
• Change in picking or biting behavioral frequency [Срок оценки: baseline and post intervention (approximately 90 minutes)]
• Change in picking or biting behaviors duration [Срок оценки: baseline and post intervention (approximately 90 minutes)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Kentucky — Lexington

Идентификаторы

NCT: NCT07019571 · 101505

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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