Pilot Study of Feasibility and Tolerability of Transcranial Direct Current Stimulation With Concurrent Cognitive Training
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- number of subjects recruited
研究概览
简要总结
In this study, the investigators are testing transcranial direct current stimulation (tDCS) in breast cancer survivors. In this pilot study, the investigators want to learn if it is feasible to use this device in memory rehabilitation.
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer survivors treated with chemotherapy between 40 and 65 years of age with no evidence of disease with treatment completed at least six months prior to study participation with or without current endocrine therapy.
- •Self-reported new onset since initiation of treatment cognitive dysfunction as determined by telephone screen using the brief (3 questions) assessment established by Ercoli et al. [3] (endorsement on all three questions):
- •Do you think or feel that your memory or mental ability has gotten worse since you completed your breast cancer treatment?
- •Do you think that your mind isn't as sharp now as it was before your breast cancer treatments?
- •Do you feel like these problems have made it harder to function on your job or take care of things around the home?
- •In the judgment of the investigators and/or consenting professional, able to read and comprehend English
- •In the judgment of the consenting professional cognitively able to provide informed consent
排除标准
- •Patients with prior history of primary Central Nervous System (CNS) cancer or CNS metastases
- •As per self report and/or medical record history of diagnosed neurological illness including seizure disorder, a dementing condition, or other neurological illness (multiple sclerosis, history of cerebrovascular accident, etc.)
- •Participants with untreated depression or anxiety as assessed by self-report and review of medical history;
- •Participants with a history of treated or untreated schizophrenia or bipolar disorder as assessed by self report and review of medical history;
- •As per self report participants who are pregnant or who are breastfeeding
- •As per self report participants with pacemakers, intracranial electrodes, implanted defibrillators or any other prosthesis.
研究组 & 干预措施
tDCS with cognitive training
We will collect: 1) self-reported demographic information (~5 min) 2) cognitive functioning data (PAOFI) at session 1 and session 4 (~10min) [60]; 3) behavioral data and EEG data from the tDCS stimulation task for each session (downloaded by investigators); 4) patient feedback on their experience with tDCS (tDCS Patient Experience Questionnaire (tPEQ)) for each session (~5 min); 5) tDCS accrual and session completion rates at the completion of treatment and 6) Brunoni Adverse Events Questionnaire (~5 min)
干预措施: Transcranial Direct Current Stimulation (tDCS) (Device)
tDCS with cognitive training
We will collect: 1) self-reported demographic information (~5 min) 2) cognitive functioning data (PAOFI) at session 1 and session 4 (~10min) [60]; 3) behavioral data and EEG data from the tDCS stimulation task for each session (downloaded by investigators); 4) patient feedback on their experience with tDCS (tDCS Patient Experience Questionnaire (tPEQ)) for each session (~5 min); 5) tDCS accrual and session completion rates at the completion of treatment and 6) Brunoni Adverse Events Questionnaire (~5 min)
干预措施: Questionnaires (Behavioral)
结局指标
主要结局
number of subjects recruited
时间窗: 6 months
feasibility defined by the number of subjects recruited in a six month time frame
次要结局
未报告次要终点