A Feasibility Study of Transcranial Direct Current Stimulation (tDCS) as an Adjunctive Treatment for Treatment Resistant Depression (TRD) in Hospitalized Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Feasibility outcome
研究概览
简要总结
The researchers are trying to test the feasibility and acceptability of using transcranial Direct Current Stimulation (tDCS) in hospitalized adult patients with Treatment Resistant Depression (TRD), assess for any preliminary effect on depressive and cognitive symptoms, and explore the utility of biomarkers to assess response to tDCS.
详细描述
In this feasibility study the researchers propose to conduct a 5-day tDCS treatment protocol in hospitalized adult patients with TRD, with each treatment session lasting for 30 minutes, delivered twice daily, for a total of 10 stimulations over 5 days. Before and after the 5-day tDCS treatment protocol, assessments will include Montgomery-Asberg Depression Rating Scale (MADRS) to measure depressive symptoms, Snaith-Hamilton Pleasure Scale (SHAPS) to measure anhedonia, Stroop Test to measure memory and executive function, Revised Hopkins Verbal Learning Test (HVLT-R) to test verbal learning and memory, and Digital Symbol Coding Test (DSCT) to measure working memory. Electroencephalography (EEG) for objective electrophysiologic data will also be collected before and after tDCS. A wireless EEG unit (CGX, Cognionic, Inc.) will be used to collect EEG and peak alpha frequency (PAF) as potential target engagement marker for tDCS. The PAF measures the highest magnitude within the alpha range of brain oscillations, thought to reflect cognitive performance. Other potential predictors of treatment response measures collected at baseline include Adverse Childhood Experiences (ACE), premorbid intelligence quotient (pIQ), Wide Range Achievement Reading Test (WRART), and Socioeconomic Status (SES).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Feasibility outcome
时间窗: through study completion, an average of 2 weeks
Defined as 70% of eligible patients choosing to enroll in the study. Other feasibility parameters will include willingness of clinicians to refer and help recruit patients, number of eligible participants, willingness of participants to enroll, retention of patients, and completeness of data collection.
Tolerability outcome
时间窗: through study completion, an average of 2 weeks
Defined as an overall tolerability rating of "very tolerable." This will be a self-report based on a global question "Considering all aspects of your experience, how would you rate the overall tolerability of the tDCS intervention?" The response options are: very tolerable, somewhat tolerable, neutral, somewhat intolerable, and very intolerable. Other tolerability parameters will include the tDCS adverse effects questionnaire.
Acceptability outcome
时间窗: through study completion, an average of 2 weeks
Defined as 80% of study participants completing 80% of the 10-session tDCS treatment protocol. Investigators will also ask participants about their satisfaction, perceptions, and experiences with the tDCS treatments. Other acceptability parameters will include rates of adherence to tDCS protocol, dropout rates and reasons for non-completion.
次要结局
- Change in Revised Hopkins Verbal Learning Test (HVLT-R)(baseline, 2 weeks)
- Change in Stroop Test(baseline, 2 weeks)
- Change in Snaith-Hamilton Pleasure Scale (SHAPS)(baseline, 2 weeks)
- Change in Montgomery-Asberg Depression Rating Scale (MADRS)(baseline, 2 weeks)
- Change in Digital Symbol Coding Test (DSCT)(baseline, 2 weeks)
- Change in Peak alpha frequency (PAF)(baseline, 2 weeks)
研究者
Maria I. Lapid, M.D.
Principal Investigator
Mayo Clinic