Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anodal tDCS | Active Comparator | 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. |
|
| sham stimulation | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anodal transcranial direct current stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline (pre-intervention), immediately post-intervention, 1-month post-intervention, and 3-months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, immediately post-intervention, 1-month post-intervention, 3-months post-intervention |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Medical University | Hefei | Anhui | 230032 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham transcranial direct current stimulation | Device | 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. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | baseline (pre-intervention), immediately post-intervention, 1-month post-intervention, and 3-months post-intervention |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
Not provided
Not provided