Developing Brain Imaging Analysis Expertise for Personalizing Transcranial Electric Stimulation in Anhedonia Treatment of Patients With Bipolar Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- change in the fractional anisotropy of the uncinate fasciculus
研究概览
简要总结
The purpose of this study is to investigate whether transcranial direct-current stimulation (tDCS) will engage reward-related brain circuitry, more specifically the uncinate fasciculus (UF) tract, which connects the orbitofrontal cortex (OFC) and nucleus accumbens (NAcc) regions. Also to evaluate whether the changes in the fractional anisotropy (FA) of the UF tract are associated with changes of clinical symptoms of anhedonia and finally to investigate the moderation role of simulated electric fields (EFs) in an association between FA of the UF and symptoms of anhedonia.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of Bipolar Disorder and clinically significant anhedonia
- •mild symptoms of depression
排除标准
- •substance abuse/dependence and any use of drugs (except alcohol or nicotine) in the previous month of the baseline assessment
- •participants with personality disorder that would interfere with study participation according to clinical judgment
- •previous neurological conditions (epilepsy, traumatic brain injury, stroke, etc)
- •any severe, life-threatening non-psychiatric medical condition
- •specific contraindications for tDCS (metallic plates in the head)
- •Participants identified as acutely suicidal or severely agitated
研究组 & 干预措施
active tDCS
干预措施: active tDCS (Device)
sham tDCS
干预措施: sham tDCS (Device)
结局指标
主要结局
change in the fractional anisotropy of the uncinate fasciculus
时间窗: baseline, 6 weeks
Change in the fractional anisotropy of the uncinate fasciculus as assessed by diffusion tensor imaging (DTI)
次要结局
- changes in symptoms of anhedonia as assessed by the Snaith-Hamilton Pleasure Scale modified for clinical administration (SHAPS-C)(baseline, 6 weeks)
- change in symptoms of anticipatory anhedonia as assessed by the Temporal Experience of Pleasure Scale (TEPS)(baseline, 6 weeks)
- change in symptoms of consummatory anhedonia as assessed by the Temporal Experience of Pleasure Scale (TEPS)(baseline, 6 weeks)
研究者
Jair Soares
Professor
The University of Texas Health Science Center, Houston