Transcranial Direct Current Stimulation (tDCS)NCT07083518
Transcranial Direct Current Stimulation for Cancer-related Cognitive Impairment in Breast Cancer Survivors
A study testing Anodal transcranial direct current stimulation in people with Transcranial Direct Current Stimulation (tDCS) and Breast Cancer Survivor, run by Anhui Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Transcranial Direct Current Stimulation (tDCS), Breast Cancer Survivor, Cognitive Impairment
- What is being tested?
- Anodal transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 29 May 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Mechanisms of Transcranial Direct Current Stimulation (tDCS) on Cancer-Related Cognitive Impairment(CRCI) in Breast Cancer Survivors: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Transcranial Direct Current Stimulation (tDCS), Breast Cancer Survivor, Cognitive Impairment
- Being tested
- Anodal transcranial direct current stimulation, Sham transcranial direct current stimulation
- Keywords
- tDCS, breast cancer, cognitive impairment
- Medical subject headings
- Cognitive Dysfunction, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal transcranial direct current stimulationDevice
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 transcranial direct current stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Anodal transcranial direct current stimulation |
| 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. Receives: Device: Sham transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline (pre-intervention), immediately post-intervention, 1-month post-intervention, and 3-months post-intervention
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline (pre-intervention), immediately post-intervention, 1-month post-intervention, and 3-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start29 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Direct Current Stimulation (tDCS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WANG KAI, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083518
- Sponsor's protocol ID
- AHMU-tDCS-BC
- Status last verified
- May 2025
- First submitted
- 24 Jun 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Mechanisms of Transcranial Direct Current Stimulation (tDCS) on Cancer-Related Cognitive Impairment(CRCI) in Breast Cancer Survivors: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07083518
- Acronym / sponsor ID
- AHMU-tDCS-BC
- Conditions
- Transcranial Direct Current Stimulation (tDCS), Breast Cancer Survivor, Cognitive Impairment
- Keywords
- tDCS, breast cancer, cognitive impairment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 29 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS | Active comparator | Device: Anodal transcranial direct current stimulationParticipants 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 | Device: Sham transcranial direct current stimulationParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anodal transcranial direct current stimulationtDCS 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. | Device | Anodal tDCS |
| Sham transcranial direct current stimulationSham 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. | Device | sham stimulation |
Primary outcome
Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
Time frame: 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.
8 secondary outcomes
Trail Making Test
Time frame: baseline, immediately post-intervention, 1-month post-intervention, 3-months post-intervention
Digit Span Test
Time frame: baseline (pre-intervention), immediately post-intervention, 1-month post-intervention, and 3-months post-intervention
Auditory Verbal Learning Test
Time frame: baseline, immediately post-intervention, 1-month post-intervention, and 3-months post-intervention
Piper Cancer-Related Fatigue Scale Score (PFS)
Time frame: baseline (pre-intervention), immediately post-intervention, 1-month post-intervention, and 3-months post-intervention
Hamilton Depression Rating Scale (HAMD)
Time frame: baseline (pre-intervention), immediately post-intervention, 1-month post-intervention, and 3-months post-intervention
Hamilton Anxiety Scale(HAMA)
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)
Time frame: baseline (pre-intervention), immediately post-intervention, 1-month post-intervention, and 3-months post-intervention
The change of resting-state electroencephalography (EEG)
Time frame: baseline (pre-intervention), immediately post-intervention, 1-month post-intervention, and 3-months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal transcranial direct current stimulation in people with Transcranial Direct Current Stimulation (tDCS) and Breast Cancer Survivor, run by Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) (time frame: baseline (pre-intervention), immediately post-intervention, 1-month post-intervention, and 3-months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.