Efficacy and Mechanisms of Transcranial Direct Current Stimulation (tDCS) on Cancer-Related Cognitive Impairment(CRCI) in Breast Cancer Survivors: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
研究概览
简要总结
This study aims to evaluate the efficacy of transcranial direct current stimulation (tDCS) in improving cancer-related cognitive impairment (CRCI) in breast cancer survivors. Participants will be randomly assigned to receive active or sham stimulation over the prefrontal cortex. Cognitive outcomes will be assessed using standardized neuropsychological tests and self-reported measures. Functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) will be used to explore neural correlates of intervention effects.
详细描述
This study is designed to evaluate the therapeutic effects of transcranial direct current stimulation (tDCS) on cancer-related cognitive impairment (CRCI) in breast cancer survivors. CRCI is a common and persistent complication among patients treated with systemic cancer therapies and has a substantial impact on quality of life, even after completion of treatment. Participants will be female breast cancer survivors who have completed primary treatments and report cognitive complaints. Eligible individuals will be randomized in a 1:1 ratio to receive either active or sham tDCS. The stimulation will be applied over the left dorsolateral prefrontal cortex (DLPFC), a brain region involved in executive function, memory, and attention. Each participant will receive multiple sessions of tDCS across a defined intervention period. The primary outcome will be the change in perceived cognitive function, measured by the total score of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) questionnaire. Secondary outcomes will include objective performance on neuropsychological tests (Trail Making Test, Auditory Verbal Learning Test, Digit Span Test), as well as patient-reported fatigue (Piper Fatigue Scale) and emotional symptoms (HAMD, HAMA). Neuroimaging (fMRI) and electrophysiological (EEG) data will also be collected in a subset of participants to explore neural correlates of treatment effects.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female breast cancer survivors aged 18-65 years.
- •Initially diagnosed with stage I-III non-metastatic breast cancer.
- •Between 6 months and 5 years after completion of initial curative surgery +/- radiation/chemotherapy.
- •allowed to be on endocrine therapy and/or anti-HER2 targeted therapy.
- •Self-reported cognitive complaints following cancer treatment.
- •Right-handedness (for standardized tDCS targeting)
- •Education level ≥ 6 years
- •Able and willing to undergo all study procedures (neuropsychological testing, MRI, EEG, etc.) and to provide written informed consent
排除标准
- •Contraindications to MRI or EEG (e.g., pacemaker, metallic implants, claustrophobia).
- •Active neurological/psychiatric disorders (e.g., major depressive disorder, bipolar disorder, schizophrenia, Parkinson's disease, post-stroke sequelae)
- •Concurrent use of cognition-enhancing medications (e.g., donepezil, memantine)
- •Severe somatic diseases (cardiac/hepatic/renal insufficiency)
- •Pregnant or breastfeeding
- •Concurrent participation in another interventional clinical trial
研究组 & 干预措施
Anodal tDCS
Participants will receive active tDCS for 20 minutes daily, 5 sessions per week, over 4 consecutive weeks (total 20 sessions). The anodal electrode was placed on the DLPFC (F3) surrounded by four cathodes with 1-cm diameter (FCz, AFz, F7, and C5). The stimulation direct current magnitude was set at 2 mA with a 30-s immediate decline at the beginning and end of each phase.
干预措施: Anodal transcranial direct current stimulation (Device)
sham stimulation
Participants will receive sham stimulation for 20 minutes daily, 5 sessions per week, over 4 consecutive weeks (total 20 sessions). In the sham condition, a 30-s rising current until 2 mA is reached, with a 30-s decline immediately at the beginning and end of the stimulation section.
干预措施: Sham transcranial direct current stimulation (Device)
结局指标
主要结局
Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
时间窗: baseline (pre-intervention), immediately post-intervention, 1-month post-intervention, and 3-months post-intervention
FACT-Cog is a validated self-report instrument designed to assess perceived cognitive function in cancer patients and survivors. It evaluates the individual's subjective experience of cognitive abilities during and after cancer treatment. Higher total scores reflect better perceived cognitive functioning. Only the overall score will be used as the outcome measure in this study.
次要结局
- The Changes of Functional Magnetic Resonance Imaging (fMRI)(baseline (pre-intervention), immediately post-intervention, 1-month post-intervention, and 3-months post-intervention)
- Trail Making Test(baseline, immediately post-intervention, 1-month post-intervention, 3-months post-intervention)
- Digit Span Test(baseline (pre-intervention), immediately post-intervention, 1-month post-intervention, and 3-months post-intervention)
- Auditory Verbal Learning Test(baseline, immediately post-intervention, 1-month post-intervention, and 3-months post-intervention)
- Piper Cancer-Related Fatigue Scale Score (PFS)(baseline (pre-intervention), immediately post-intervention, 1-month post-intervention, and 3-months post-intervention)
- Hamilton Depression Rating Scale (HAMD)(baseline (pre-intervention), immediately post-intervention, 1-month post-intervention, and 3-months post-intervention)
- Hamilton Anxiety Scale(HAMA)(baseline (pre-intervention), immediately post-intervention, 1-month post-intervention, and 3-months post-intervention)
- The change of resting-state electroencephalography (EEG)(baseline (pre-intervention), immediately post-intervention, 1-month post-intervention, and 3-months post-intervention)
研究者
WANG KAI
Head, Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab, PRC
Anhui Medical University