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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
tDCS is described as a non-invasive form of brain stimulation that uses a low-intensity, direct current applied directly to the head through scalp electrodes.
Sham tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.
Anhui Medical University
Hefei, Anhui, China
Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
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.
Time frame: baseline (pre-intervention), immediately post-intervention, 1-month post-intervention, and 3-months post-intervention
Trail Making Test
Executive function will be assessed using the Trail Making Test, including Part A (visual attention and processing speed) and Part B (task switching and cognitive flexibility). Higher completion times reflect poorer performance. The difference in completion time from baseline will be used as the outcome.
Time frame: baseline, immediately post-intervention, 1-month post-intervention, 3-months post-intervention
Digit Span Test
Working memory will be assessed using the Digit Span Test (forward and backward conditions). Scores reflect the maximum number of digits recalled in correct order.
Time frame: baseline (pre-intervention), immediately post-intervention, 1-month post-intervention, and 3-months post-intervention
Auditory Verbal Learning Test
Verbal memory will be assessed using the Auditory Verbal Learning Test (AVLT), including immediate recall (sum of trials), delayed recall, and recognition accuracy. Scores reflect the number of correctly recalled or recognized items.
Time frame: baseline, immediately post-intervention, 1-month post-intervention, and 3-months post-intervention
Piper Cancer-Related Fatigue Scale Score (PFS)
The Piper Cancer-Related Fatigue Scale (PFS) is a validated self-report instrument used to assess the severity of cancer-related fatigue. It contains 22 items scored on a 0-10 scale, with higher total scores indicating greater fatigue severity. Only the total score will be used as the outcome measure.
Time frame: baseline (pre-intervention), immediately post-intervention, 1-month post-intervention, and 3-months post-intervention
Hamilton Depression Rating Scale (HAMD)
The changes in HAMD will constitute the secondary research outcome. The Hamilton Depression Scale (HAMD), compiled by Hamilton in 1960, is the most common clinical scale to assess depression. In this study, 17 versions were selected, and there were 17 questions. Each question scored between 0 and 4 points. Higher scores indicate more depressive symptoms. The severity of the disease and the therapeutic effect can be evaluated after treatment. Endpoint: Difference between each time point's total score and baseline; negative Δ indicates symptom relief. Analysis: Repeated measures mixed-effects model, exploring the moderating effect of mood on cognitive outcomes.
Time frame: baseline (pre-intervention), immediately post-intervention, 1-month post-intervention, and 3-months post-intervention
Hamilton Anxiety Scale(HAMA)
The Hamilton Anxiety Scale (HAMA) was compiled by Hamilton in 1959. It was one of the most commonly used scales in psychiatric clinics, including 14 items. It is often used in clinical diagnosis and degree classification of anxiety disorder. Endpoint: Difference between each time point's total score and baseline; negative Δ indicates symptom relief. Analysis: Repeated measures mixed-effects model, exploring the moderating effect of mood on cognitive outcomes.
Time frame: baseline (pre-intervention), immediately post-intervention, 1-month post-intervention, and 3-months post-intervention
The Changes of Functional Magnetic Resonance Imaging (fMRI)
The change of resting-state functional connectivity strength between the stimulated target and the whole brain areas will be measured by functional magnetic resonance imaging (fMRI): within-subject changes in (1) resting-state functional connectivity among key networks, (2) regional brain volumes (e.g., prefrontal cortex, hippocampus), and (3) white matter integrity (fractional anisotropy, mean diffusivity), reflecting tDCS effects on brain structure and function.
Time frame: baseline (pre-intervention), immediately post-intervention, 1-month post-intervention, and 3-months post-intervention
The change of resting-state electroencephalography (EEG)
The change of resting-state functional connectivity strength between the stimulated target and the whole brain areas will be measured by resting-state electroencephalography (EEG): preprocessing (filtering, artifact removal), computation of relative power in δ/θ/α/β/γ bands, and extraction of P300 amplitude and latency. Endpoint: Difference in spectral power and ERP metrics relative to baseline. Analysis: Repeated measures ANOVA with post-hoc Bonferroni correction.
Time frame: baseline (pre-intervention), immediately post-intervention, 1-month post-intervention, and 3-months post-intervention
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