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

NCT07112521 | Recruiting

• 1 other identifier: LTDK nro7/2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Breast Cancer Survivor; Obesity, Overweight

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Attention at post-intervention

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

  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.

  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.

  From baseline to the end of the intervention at 6 weeks

Secondary Outcomes (13)

• Attention at short-term follow-up

  From baseline to 3 weeks after the end of the intervention

• Short-term episodic memory at short-term follow-up

  From baseline to 3 weeks after the end of the intervention

• Processing speed at short-term follow-up

  From baseline to 3 weeks after the end of the intervention

• Attention at long-term follow-up

  From baseline to 9 weeks after the end of the intervention

• Short-term episodic memory at long-term follow-up

  From baseline to 9 weeks after the end of the intervention

Other Outcomes (6)

• Dynamics of attention skills throughout the intervention

  From baseline to week 1-3-5 during the the intervention

• Dynamics of short-term episodic memory skills throughout the intervention

  From baseline to week 1-3-5 during the the intervention

• Dynamics of processing speed skills throughout the intervention

  From baseline to week 1-3-5 during the the intervention

Study Arms (2)

Active tDCS

EXPERIMENTAL

Device: active tDCS

sham tDCS

SHAM COMPARATOR

Device: sham tDCS

Interventions

active tDCS DEVICE

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.

Active tDCS

sham tDCS DEVICE

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.

sham tDCS

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Helsinki: lead

Study Sites (1)

Department of Psychology, Faculty of Medicine, University of Helsinki

Helsinki, Uusimaa, 00200, Finland

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Manon Chédeville, Doctoral Researcher

CONTACT

+358 50 326 4109; manon.chedeville@helsinki.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: August 8, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

FI (1)