NCT07083518

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

Efficacy and Mechanisms of Transcranial Direct Current Stimulation (tDCS) on Cancer-Related Cognitive Impairment(CRCI) in Breast Cancer Survivors: A Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Anhui Medical University · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is designed to evaluate the therapeutic effects of transcranial direct current stimulation (tDCS) on cancer-related cognitive impairment (CRCI) in breast cancer survivors. CRCI is a common and persistent complication among patients treated with systemic cancer therapies and has a substantial impact on quality of life, even after completion of treatment. Participants will be female breast cancer survivors who have completed primary treatments and report cognitive complaints. Eligible individuals will be randomized in a 1:1 ratio to receive either active or sham tDCS. The stimulation will be applied over the left dorsolateral prefrontal cortex (DLPFC), a brain region involved in executive function, memory, and attention. Each participant will receive multiple sessions of tDCS across a defined intervention period. The primary outcome will be the change in perceived cognitive function, measured by the total score of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) questionnaire. Secondary outcomes will include objective performance on neuropsychological tests (Trail Making Test, Auditory Verbal Learning Test, Digit Span Test), as well as patient-reported fatigue (Piper Fatigue Scale) and emotional symptoms (HAMD, HAMA). Neuroimaging (fMRI) and electrophysiological (EEG) data will also be collected in a subset of participants to explore neural correlates of treatment effects.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Anodal transcranial direct current stimulation	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.
DEVICE	Sham transcranial direct current stimulation	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.

Timeline

• Start date: 2025-05-29
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2025-07-24
• Last updated: 2025-07-24

Locations

1 site across 1 country: China