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RecruitingNCT07112521LUMINA-brainUpdated Sep 2, 2025

tDCS Intervention in Breast Cancer Survivors With and Without Obesity Reporting Cognitive Impairment

An interventional study of active tDCS and sham tDCS in Breast Cancer Survivor and Obesity, Overweight, sponsored by University of Helsinki. Recruiting at 1 site in Finland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-02.

Sponsored by University of Helsinki · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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. 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):

  1. 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.
  2. 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.
  3. 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.
02

Conditions studied

  • Breast Cancer Survivor
  • Obesity, Overweight

Keywords

  • tdcs
  • CRCI
  • breast cancer survivors
  • obesity
  • transcranial direct current stimulation
  • cancer related cognitive impairment
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 40 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of Helsinki is the lead sponsor of 129 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Active tDCS

    Device: active tDCS

  • Sham comparator
    sham tDCS

    Device: sham tDCS

Interventions

  • Deviceactive tDCS

    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.

  • Devicesham tDCS

    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.

06

What researchers measure

Primary outcomes

  1. Attention at post-intervention

    Performance in the Matching Cards task under active tDCS compared to sham: the mean number of correct trials.

    Time frame: From baseline to the end of the intervention at 6 weeks

  2. 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.

    Time frame: From baseline to the end of the intervention at 6 weeks

  3. Processing speed at post-intervention

    Performance in Symbol Search task under active tDCS compared to sham: prompt-level median response latency for correct trials.

    Time frame: From baseline to the end of the intervention at 6 weeks

Secondary outcomes

  1. Attention at short-term follow-up

    Performance in the Matching Cards task under active tDCS compared to sham: the mean number of correct trials.

    Time frame: From baseline to 3 weeks after the end of the intervention

  2. 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.

    Time frame: From baseline to 3 weeks after the end of the intervention

  3. 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.

    Time frame: From baseline to 3 weeks after the end of the intervention

  4. Attention at long-term follow-up

    Performance in the Matching Cards task under active tDCS compared to sham: the mean number of correct trials.

    Time frame: From baseline to 9 weeks after the end of the intervention

  5. 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.

    Time frame: From baseline to 9 weeks after the end of the intervention

  6. 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.

    Time frame: From baseline to 9 weeks after the end of the intervention

  7. Gray matter changes at long-term follow-up

    Volume of gray matter under active tDCS compared to sham.

    Time frame: From baseline to 9 weeks after the end of the intervention

  8. Gray matter changes at long-term follow-up

    Thickness of gray matter under active tDCS compared to sham.

    Time frame: From baseline to 9 weeks after the end of the intervention

  9. White matter changes at long-term follow-up

    Neurite density index under active tDCS compared to sham.

    Time frame: From baseline to 9 weeks after the end of the intervention

  10. White matter changes at long-term follow-up

    Orientation dispersion index under active tDCS compared to sham.

    Time frame: From baseline to 9 weeks after the end of the intervention

  11. White matter changes at long-term follow-up

    Free-water fraction under active tDCS compared to sham.

    Time frame: From baseline to 9 weeks after the end of the intervention

  12. 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.

    Time frame: From baseline to 9 weeks after the end of the intervention

  13. 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.

    Time frame: From baseline to 9 weeks after the end of the intervention

Other outcomes

  1. Dynamics of attention skills throughout the intervention

    Performance in the Matching Cards task under active tDCS compared to sham: the mean number of correct trials from each prompted assessment.

    Time frame: From baseline to week 1-3-5 during the the intervention

  2. Dynamics of short-term episodic memory skills throughout the intervention

    Performance in the dot memory task under active tDCS compared to sham: the mean Euclidean distance score from each prompted assessment.

    Time frame: From baseline to week 1-3-5 during the the intervention

  3. Dynamics of processing speed skills throughout the intervention

    Performance in Symbol Search task under active tDCS compared to sham: the mean of the prompt-level median response latency for correct trials.

    Time frame: From baseline to week 1-3-5 during the the intervention

  4. Depression and anxiety score at post-intervention

    HADS score under active tDCS compared to sham.

    Time frame: From baseline to the end of treatment at 6 weeks

  5. Depression and anxiety score at short-term follow-up

    HADS score under active tDCS compared to sham.

    Time frame: From baseline to 3 weeks after the end of the intervention

  6. Depression and anxiety score at long-term follow-up

    HADS score under active tDCS compared to sham.

    Time frame: From baseline to 9 weeks after the end of the intervention

07

Study locations

1 of 1 sites recruiting
  • Department of Psychology, Faculty of Medicine, University of Helsinki
    Helsinki, Uusimaa 00200, Finland
    • Manon Chédeville, Doctoral Researcher · Contact · manon.chedeville@helsinki.fi · +358 50 326 4109
    • Professor Horstmann · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07112521
Lead sponsor
University of Helsinki
Responsible party
Annette Horstmann (Professor, University of Helsinki) — Principal investigator
First posted
Aug 8, 2025
Start date
Sep 1, 2025 (estimated)
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Sep 2, 2025

Study contacts

Manon Chédeville, Doctoral Researcher
Contact
manon.chedeville@helsinki.fi
+358 50 326 4109

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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