RecruitingNot ApplicableNCT07112521

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

Evaluating the Efficacy of Home-Based tDCS for Cancer-Related Cognitive Impairment and Its Moderation by Obesity: A Double-Blind Randomized Controlled Trial.


Sponsor

University of Helsinki

Enrollment

40 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria8

  • 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 Criteria10

  • 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

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.


Locations(1)

Department of Psychology, Faculty of Medicine, University of Helsinki

Helsinki, Uusimaa, Finland

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NCT07112521


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