Transcranial Direct Current Stimulation for Cancer-related Cognitive Impairment in Breast Cancer Survivors

NCT07083518 | Active Not Recruiting

• 1 other identifier: AHMU-tDCS-BC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Transcranial Direct Current Stimulation (tDCS); Breast Cancer Survivor; Cognitive Impairment

Keywords

tDCS; breast cancer; cognitive impairment

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline (pre-intervention), immediately post-intervention, 1-month post-intervention, and 3-months post-intervention

Secondary Outcomes (8)

• Trail Making Test

  baseline, immediately post-intervention, 1-month post-intervention, 3-months post-intervention

• Digit Span Test

  baseline (pre-intervention), immediately post-intervention, 1-month post-intervention, and 3-months post-intervention

• Auditory Verbal Learning Test

  baseline, immediately post-intervention, 1-month post-intervention, and 3-months post-intervention

• Piper Cancer-Related Fatigue Scale Score (PFS)

  baseline (pre-intervention), immediately post-intervention, 1-month post-intervention, and 3-months post-intervention

• Hamilton Depression Rating Scale (HAMD)

  baseline (pre-intervention), immediately post-intervention, 1-month post-intervention, and 3-months post-intervention

Study Arms (2)

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.

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.

Device: Sham transcranial direct current stimulation

Interventions

Anodal transcranial direct current stimulation DEVICE

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.

Anodal tDCS

Sham transcranial direct current stimulation DEVICE

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.

sham stimulation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Anhui Medical University

Hefei, Anhui, 230032, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Breast Neoplasms

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab, PRC

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 24, 2025
• Study Start: May 29, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 24, 2025

Record last verified: 2025-05

Locations

CN (1)