Breast Cancer SurvivorLUMINA-brainNCT07112521
tDCS Intervention in Breast Cancer Survivors With and Without Obesity Reporting Cognitive Impairment
A study testing active tDCS in people with Breast Cancer Survivor and Obesity, Overweight, run by University of Helsinki at 1 site in Finland.
Trial summary
The goal of this intervention is to investigate whether transcranial Direct Current Stimulation (tDCS) can alleviate Cancer-Related Cognitive Impairment (CRCI) in breast cancer survivors, as measured by changes in brain structures and cognitive performance. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Survivor, Obesity, Overweight
- What is being tested?
- active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- 1 Sep 2025to Jan 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Over 18 years old
- Diagnosed with primary adult-onset breast cancer within the last 5 years
- Completed all active cancer treatments at least 3 months prior to study participation
- Capable of fulfilling study requirements, including having internet access.
- Fluent in either Finnish or English
- Have normal or corrected vision and hearing
- Right-handed (based on the Edinburgh Handedness Inventory score; Oldfield, 1971)
Who cannot join
- Have received primary cancer treatment (chemotherapy, radiotherapy, immunotherapy, or surgery) within the last 3 months
- Have a history of childhood-onset cancer
- Present with acute eczema on the scalp
- Diagnosed with dementia, Alzheimer's disease, multiple sclerosis, or - Parkinson's disease
- Have experienced unconsciousness for more than five minutes due to a head/brain injury within the last 10 years
- Have a history of stroke or transient ischemic attack
Show all 10Show fewer
- Suffer from claustrophobia
- Are pregnant or breastfeeding
- Have any of the following medical implants or devices: cardiac implantable electronic devices, metallic intraocular foreign bodies, neurostimulation systems, cochlear/ear implants, drug infusion pumps, catheters with metal components, metallic fragments (e.g., bullets), cerebral aneurysm clips, magnetic dental implants, tissue expanders, artificial limbs, non-removable piercings, or face tattoos.
- Weight exceeding 250 kg (the MRI table weight limit) or they are unable to fit within the 70 cm diameter bore of the MRI machine
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Department of Psychology, Faculty of Medicine, University of Helsinki
Helsinki, Uusimaa, 00200
Manon Chédeville, Doctoral Researcher, +358 50 326 4109, manon.chedeville@helsinki.fi
Professor Horstmann
About this study
Official title: Evaluating the Efficacy of Home-Based tDCS for Cancer-Related Cognitive Impairment and Its Moderation by Obesity: A Double-Blind Randomized Controlled Trial.
The goal of this intervention is to investigate whether transcranial Direct Current Stimulation (tDCS) can alleviate Cancer-Related Cognitive Impairment (CRCI) in breast cancer survivors, as measured by changes in brain structures and cognitive performance. To assess the efficacy of tDCS, the investigators will compare outcomes between participants receiving active stimulation and those receiving sham stimulation (a placebo condition where participants believe they are receiving stimulation, but are not).
Participants will:
- Undergo a baseline MRI session
- Receive either active or sham tDCS for six weeks
- Undergo a follow-up MRI session
- Complete cognitive tests and respond to psychosocial questionnaires before, during, and after the tDCS intervention
Read the detailed description
Cancer-Related Cognitive Impairment (CRCI) is common among breast cancer (BC) survivors, manifesting as deficits in memory, attention, and processing speed, further affecting their quality of life. CRCI is likely multifactorial, influenced by demographic and genetic factors, neuroinflammation, and neuroplasticity changes. On the one hand, obesity is a known risk factor for BC and a poorer prognosis. On the other hand, it is linked to neuroinflammation and structural brain changes that contribute to cognitive impairment. However, its role in exacerbating CRCI remains unclear. Understanding this relationship is crucial for optimizing cognitive rehabilitation strategies. Transcranial Direct Current Stimulation (tDCS) is a promising neuromodulation technique that enhances neuroplasticity, and its potential for home-based application could improve treatment feasibility. This study aims to (1) evaluate the effectiveness of home-based tDCS in improving cognitive function in BC survivors and (2) examine obesity as a potential moderator of treatment outcomes. The investigators will conduct a double-blind, sham-controlled tDCS intervention over six weeks, collecting cognitive assessments and dietary data before, during, and after the intervention. MRI scans will be acquired pre- and post-intervention to assess structural and functional changes in cognition-related regions.
Participants will complete five phases over seventeen weeks: baseline, intervention (acute schedule), intervention (continuing schedule), short-term follow-up, and long-term follow-up:
- Seven of these seventeen weeks are designated as assessment weeks, during which participants complete cognitive tests and maintain a food diary over 2 different days.
- Assessment weeks are scheduled at baseline, every other week throughout the intervention and short-term follow-up, and once during long-term follow-up.
- Questionnaires on sleep, physical activity, cognition, and quality of life are completed once per phase.
- tDCS sessions follow a structured schedule, occurring five times per week during the first three weeks and three times per week during the last three weeks.
- MRI scans are performed at baseline and long-term follow-up.
Cognitive assessment includes three cognitive tests representing three domains known to be impaired following breast cancer (Small et al., 2019):
- Short-term episodic memory, using the Dot Memory task: a 5x5 grid will be shown on the screen with three cells containing red dots. The grid and dots remained on the screen for 3 seconds, and participants were told to remember which boxes contained the red dots. Then, in a distractor task, participants had to touch all the F's on a screen of E's and F's that is presented for 8 seconds. Finally, participants will be instructed to touch the three boxes that contain the red dots on an empty grid. They will perform the task for 12 trials, taking a 15-second break every 4 trials.
- Speed processing using the Symbol Search task: Three pairs of symbols will be displayed at the top of the screen. Participants will be instructed to find a pair of matching symbols as quickly as possible from two choices at the bottom of the screen. They will perform the task for 60 trials, taking a 15-second break every 20 trials.
- Attention, using the Card Matching task: Participants will be presented with images of three playing cards in a row and asked to indicate whether the first and third cards are identical. The cards will then shift one place to the left and a new card will be introduced in the third position. After this practice, the first two cards will be flipped so that the faces are not visible and participants will have to recall the card value in the series that transitions to the first card spot in order to match the card value in the third spot which is visible to the participant. They will perform the task for 60 trials, taking a 15-second break every 20 trials.
- Conditions
- Breast Cancer Survivor, Obesity, Overweight
- Being tested
- active tDCS, sham tDCS
- Keywords
- tdcs, CRCI, breast cancer survivors, obesity, transcranial direct current stimulation, cancer related cognitive impairment
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active tDCSDevice
The anodal electrode will be placed over the left DLPFC (F3), and the cathodal electrode will be placed over the right supraorbital area (FP2). The current will be gradually ramped up to 2mA over 30 seconds, held constant at 2mA for 29 minutes, and then gradually ramped down to 0mA over the final 30 seconds.
sham tDCSDevice
The anodal electrode will be placed over the left DLPFC (F3), and the cathodal electrode will be placed over the right supraorbital area (FP2). The current will be initially ramped up to 2mA over 30 seconds and immediately ramped back down to 0mA.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | Not described Receives: Device: active tDCS |
| sham tDCS | Sham comparator | Not described Receives: Device: sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention at post-intervention
Performance in the Matching Cards task under active tDCS compared to sham: the mean number of correct trials.
Measured: From baseline to the end of the intervention at 6 weeks
Short-term episodic memory at post-intervention
Performance in the dot memory task under active tDCS compared to sham: the mean Euclidean distance score.
The mean Euclidean distance score reflects the distance between the original red dot locations and the recalled locations.
Measured: From baseline to the end of the intervention at 6 weeks
Processing speed at post-intervention
Performance in Symbol Search task under active tDCS compared to sham: prompt-level median response latency for correct trials.
Measured: From baseline to the end of the intervention at 6 weeks
Secondary outcomes (13)
Attention at short-term follow-up
Performance in the Matching Cards task under active tDCS compared to sham: the mean number of correct trials.
Measured: From baseline to 3 weeks after the end of the intervention
Short-term episodic memory at short-term follow-up
Performance in the dot memory task under active tDCS compared to sham: the mean Euclidean distance score.
The mean Euclidean distance score reflects the distance between the original red dot locations and the recalled locations.
Measured: From baseline to 3 weeks after the end of the intervention
Processing speed at short-term follow-up
Performance in Symbol Search task under active tDCS compared to sham: prompt-level median response latency for correct trials.
Measured: From baseline to 3 weeks after the end of the intervention
Attention at long-term follow-up
Performance in the Matching Cards task under active tDCS compared to sham: the mean number of correct trials.
Measured: From baseline to 9 weeks after the end of the intervention
Short-term episodic memory at long-term follow-up
Performance in the dot memory task under active tDCS compared to sham: the mean Euclidean distance score.
The mean Euclidean distance score reflects the distance between the original red dot locations and the recalled locations.
Measured: From baseline to 9 weeks after the end of the intervention
Processing speed at long-term follow-up
Performance in Symbol Search task under active tDCS compared to sham: prompt-level median response latency for correct trials.
Measured: From baseline to 9 weeks after the end of the intervention
Gray matter changes at long-term follow-up
Volume of gray matter under active tDCS compared to sham.
Measured: From baseline to 9 weeks after the end of the intervention
Gray matter changes at long-term follow-up
Thickness of gray matter under active tDCS compared to sham.
Measured: From baseline to 9 weeks after the end of the intervention
White matter changes at long-term follow-up
Neurite density index under active tDCS compared to sham.
Measured: From baseline to 9 weeks after the end of the intervention
White matter changes at long-term follow-up
Orientation dispersion index under active tDCS compared to sham.
Measured: From baseline to 9 weeks after the end of the intervention
White matter changes at long-term follow-up
Free-water fraction under active tDCS compared to sham.
Measured: From baseline to 9 weeks after the end of the intervention
Functional connectivity strength measured by Fisher-transformed bivariate correlation coefficients changes at long-term follow-up
ROI-to-ROI functional connectivity as measured by resting-state fMRI under active tDCS compared to sham.
Measured: From baseline to 9 weeks after the end of the intervention
Functional connectivity strength measured by Fisher-transformed bivariate correlation coefficients changes at long-term follow-up
Seed-based functional connectivity as measured by resting-state fMRI under active tDCS compared to sham.
Measured: From baseline to 9 weeks after the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Minimization will be applied to allocate participants to the active or sham tDCS group following a 1:1 ratio. The selected prognostic factors include prior chemotherapy (yes/no), menopausal status (pre/post), and obesity (WHtR ≥ 0.54 = living with obesity; WHtR \< 0.54 = not living with obesity).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annette Horstmann, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112521
- Sponsor's protocol ID
- LTDK nro7/2025
- Acronym
- LUMINA-brain
- Status last verified
- Aug 2025
- First submitted
- 2 Jul 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Home-Based tDCS for Cancer-Related Cognitive Impairment and Its Moderation by Obesity: A Double-Blind Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07112521
- Acronym / sponsor ID
- LUMINA-brain / LTDK nro7/2025
- Conditions
- Breast Cancer Survivor, Obesity, Overweight
- Keywords
- tdcs, CRCI, breast cancer survivors, obesity, transcranial direct current stimulation, cancer related cognitive impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 8 Aug 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.
The goal of this intervention is to investigate whether transcranial Direct Current Stimulation (tDCS) can alleviate Cancer-Related Cognitive Impairment (CRCI) in breast cancer survivors, as measured by changes in brain structures and cognitive performance. To assess the efficacy of tDCS, the investigators will compare outcomes between participants receiving active stimulation and those receiving sham stimulation (a placebo condition where participants believe they are receiving stimulation, but are not).
Participants will:
- Undergo a baseline MRI session
- Receive either active or sham tDCS for six weeks
- Undergo a follow-up MRI session
- Complete cognitive tests and respond to psychosocial questionnaires before, during, and after the tDCS intervention
Detailed description
Cancer-Related Cognitive Impairment (CRCI) is common among breast cancer (BC) survivors, manifesting as deficits in memory, attention, and processing speed, further affecting their quality of life. CRCI is likely multifactorial, influenced by demographic and genetic factors, neuroinflammation, and neuroplasticity changes. On the one hand, obesity is a known risk factor for BC and a poorer prognosis. On the other hand, it is linked to neuroinflammation and structural brain changes that contribute to cognitive impairment. However, its role in exacerbating CRCI remains unclear. Understanding this relationship is crucial for optimizing cognitive rehabilitation strategies. Transcranial Direct Current Stimulation (tDCS) is a promising neuromodulation technique that enhances neuroplasticity, and its potential for home-based application could improve treatment feasibility. This study aims to (1) evaluate the effectiveness of home-based tDCS in improving cognitive function in BC survivors and (2) examine obesity as a potential moderator of treatment outcomes. The investigators will conduct a double-blind, sham-controlled tDCS intervention over six weeks, collecting cognitive assessments and dietary data before, during, and after the intervention. MRI scans will be acquired pre- and post-intervention to assess structural and functional changes in cognition-related regions.
Participants will complete five phases over seventeen weeks: baseline, intervention (acute schedule), intervention (continuing schedule), short-term follow-up, and long-term follow-up:
- Seven of these seventeen weeks are designated as assessment weeks, during which participants complete cognitive tests and maintain a food diary over 2 different days.
- Assessment weeks are scheduled at baseline, every other week throughout the intervention and short-term follow-up, and once during long-term follow-up.
- Questionnaires on sleep, physical activity, cognition, and quality of life are completed once per phase.
- tDCS sessions follow a structured schedule, occurring five times per week during the first three weeks and three times per week during the last three weeks.
- MRI scans are performed at baseline and long-term follow-up.
Cognitive assessment includes three cognitive tests representing three domains known to be impaired following breast cancer (Small et al., 2019):
- Short-term episodic memory, using the Dot Memory task: a 5x5 grid will be shown on the screen with three cells containing red dots. The grid and dots remained on the screen for 3 seconds, and participants were told to remember which boxes contained the red dots. Then, in a distractor task, participants had to touch all the F's on a screen of E's and F's that is presented for 8 seconds. Finally, participants will be instructed to touch the three boxes that contain the red dots on an empty grid. They will perform the task for 12 trials, taking a 15-second break every 4 trials.
- Speed processing using the Symbol Search task: Three pairs of symbols will be displayed at the top of the screen. Participants will be instructed to find a pair of matching symbols as quickly as possible from two choices at the bottom of the screen. They will perform the task for 60 trials, taking a 15-second break every 20 trials.
- Attention, using the Card Matching task: Participants will be presented with images of three playing cards in a row and asked to indicate whether the first and third cards are identical. The cards will then shift one place to the left and a new card will be introduced in the third position. After this practice, the first two cards will be flipped so that the faces are not visible and participants will have to recall the card value in the series that transitions to the first card spot in order to match the card value in the third spot which is visible to the participant. They will perform the task for 60 trials, taking a 15-second break every 20 trials.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Minimization will be applied to allocate participants to the active or sham tDCS group following a 1:1 ratio. The selected prognostic factors include prior chemotherapy (yes/no), menopausal status (pre/post), and obesity (WHtR ≥ 0.54 = living with obesity; WHtR < 0.54 = not living with obesity).
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: active tDCS |
| sham tDCS | Sham comparator | Device: sham tDCS |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female
- Over 18 years old
- Diagnosed with primary adult-onset breast cancer within the last 5 years
- Completed all active cancer treatments at least 3 months prior to study participation
- Capable of fulfilling study requirements, including having internet access.
Key exclusion criteria (10 listed)
- Have received primary cancer treatment (chemotherapy, radiotherapy, immunotherapy, or surgery) within the last 3 months
- Have a history of childhood-onset cancer
- Present with acute eczema on the scalp
- Diagnosed with dementia, Alzheimer's disease, multiple sclerosis, or - Parkinson's disease
- Have experienced unconsciousness for more than five minutes due to a head/brain injury within the last 10 years
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 |
|---|---|---|
| active tDCSThe anodal electrode will be placed over the left DLPFC (F3), and the cathodal electrode will be placed over the right supraorbital area (FP2). The current will be gradually ramped up to 2mA over 30 seconds, held constant at 2mA for 29 minutes, and then gradually ramped down to 0mA over the final 30 seconds. | Device | Active tDCS |
| sham tDCSThe anodal electrode will be placed over the left DLPFC (F3), and the cathodal electrode will be placed over the right supraorbital area (FP2). The current will be initially ramped up to 2mA over 30 seconds and immediately ramped back down to 0mA. | Device | sham tDCS |
Primary outcome
Attention at post-intervention
Time frame: From baseline to the end of the intervention at 6 weeks
Performance in the Matching Cards task under active tDCS compared to sham: the mean number of correct trials.
Short-term episodic memory at post-intervention
Time frame: From baseline to the end of the intervention at 6 weeks
Performance in the dot memory task under active tDCS compared to sham: the mean Euclidean distance score. The mean Euclidean distance score reflects the distance between the original red dot locations and the recalled locations.
Processing speed at post-intervention
Time frame: From baseline to the end of the intervention at 6 weeks
Performance in Symbol Search task under active tDCS compared to sham: prompt-level median response latency for correct trials.
13 secondary outcomes
Attention at short-term follow-up
Time frame: From baseline to 3 weeks after the end of the intervention
Short-term episodic memory at short-term follow-up
Time frame: From baseline to 3 weeks after the end of the intervention
Processing speed at short-term follow-up
Time frame: From baseline to 3 weeks after the end of the intervention
Attention at long-term follow-up
Time frame: From baseline to 9 weeks after the end of the intervention
Short-term episodic memory at long-term follow-up
Time frame: From baseline to 9 weeks after the end of the intervention
Processing speed at long-term follow-up
Time frame: From baseline to 9 weeks after the end of the intervention
Gray matter changes at long-term follow-up
Time frame: From baseline to 9 weeks after the end of the intervention
Gray matter changes at long-term follow-up
Time frame: From baseline to 9 weeks after the end of the intervention
White matter changes at long-term follow-up
Time frame: From baseline to 9 weeks after the end of the intervention
White matter changes at long-term follow-up
Time frame: From baseline to 9 weeks after the end of the intervention
White matter changes at long-term follow-up
Time frame: From baseline to 9 weeks after the end of the intervention
Functional connectivity strength measured by Fisher-transformed bivariate correlation coefficients changes at long-term follow-up
Time frame: From baseline to 9 weeks after the end of the intervention
Functional connectivity strength measured by Fisher-transformed bivariate correlation coefficients changes at long-term follow-up
Time frame: From baseline to 9 weeks after the end of the 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 2 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active tDCS in people with Breast Cancer Survivor and Obesity, Overweight, run by University of Helsinki at 1 site in Finland.
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 10 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: looking for participants now, as of the sponsor's last update on 2 Sep 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 Finland. 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?
Contact Manon Chédeville, Doctoral Researcher (+358 50 326 4109, manon.chedeville@helsinki.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attention at post-intervention (time frame: From baseline to the end of the intervention at 6 weeks). The study lists 3 primary outcomes in all. 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 2 Sep 2025.