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临床试验/DRKS00020413
DRKS00020413招募中未知

Intermittent theta-burst stimulation (iTBS) as concomitant treatment for borderline personality disorder - a pilot study - DBTTMS

VR-Klinikum Düsseldorf, Kliniken der Heinrich-Heine-Universität0 个研究点目标入组 60 人开始时间: 2020年1月13日最近更新:
适应症

试验速览

阶段
未知
状态
招募中
发起方
入组人数
60

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 45 Years(—)
性别
All

入选标准

  • Borderline Personality Disorder (DSM V) assessed through a standardized clinical interview (SKID V PD)
  • - sufficient knowledge of German
  • - Age: 18-45
  • - No prior treatment with DBT
  • - If medicated stable treatment with the medication for 2 weeks before commendement of the brain stimulation treatment. Medication should remain stable during the 4-weeks of brain stimulation.
  • - Receiving inpatient or day-clinic, standardized, DBT-based treatment
  • - Participants must be able to give consent to participate
  • - Negative pregnancy test and being prepared to use contraception for the duration of brain stimulation treatment

排除标准

  • - history of seizures or epilepsy
  • - metallic implants of the skull
  • - extensive tatoos on the head
  • - significant brain tumors or brain malformations
  • - cerebrovascular events
  • - traumatic brain injury
  • - neurodegenerative disorders
  • - brain surgery
  • - deep brain stimulation
  • - Pacemaker
  • - severe somatic disorders
  • - other psychiatric comorbidities (measured by Mini-DIPS-OA) except Depression
  • - acute suicidality (MADRS Score >4 for Item 10)
  • - tinnitus
  • - pregnancy
  • - claustrophoby
  • - treatment with antiepileptic drugs
  • - taking benzodiazepines in doses exceeding 1mg Lorazepam per day
  • - patients under legal guardianship who require their guardian's approval to provide consent
  • - treatment with electroconvulsive therapy in the current episode
  • - current or prior treatment with deep brain stimulation, vagus nerv stimulation or other intracranial implants

研究者

发起方
VR-Klinikum Düsseldorf, Kliniken der Heinrich-Heine-Universität

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