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Non-Invasive Brain Stimulation and Cognitive Training for Depressive Symptomatology Related to Breast Cancer (ONCODEP)

Study acronym: ONCODEP
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated July 20, 2025 (before its estimated September 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Recruiting to Active, Not Recruitingv4 Show 4 more changesShow less
    • Enrollment target: estimated 80 to confirmed 82
    • Study description shortened, about 41 words
    • Site details revised at 2 of 2 sites
    • Eligibility criteria expanded, about 4 words
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2023 to Sep 27, 2023
    • Site details revised at 2 of 2 sites
    v3
  3. Interventions: Online Cognitive Training (Device), Sham stimulation (Device), Transcranial Alternating Current Stimulation (Device), Transcranial Direct… to Online Cognitive Training (Device), Transcranial Alternating Current Stimulation (Device), Transcranial Direct Current Stimulation…
    • Study description shortened, about 12 words
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to test a home-delivered intervention that combines Non-Invasive Brain Stimulation techniques (transcranial direct and alternating current stimulation -tDCS and tACS-) and Online Cognitive Training (OCT) to treat depressive symptomatology and cognitive decline associated with breast cancer. The main questions aims to be answered are: * To analyze the efficacy and feasibility of the intervention to treat depressive symptomatology. * To analyze the efficacy and feasibility of the intervention to treat cognitive decline. * To evaluate the medium and long-term effects (1, 3 and 6 months) of intervention. An OCT program and a portable wireless tDCS/tACS system will be used to perform the intervention at home. Patients will be divided into four treatment groups, depending on whether they will receive the OCT applied independently or combined with tDCS/tACS active or sham. In addition, saliva samples will be collected to identify bomarkers predictive of treatment efficacy.
Trial Details
NCT Number NCT06053775
Lead Sponsor University of Santiago de Compostela
Collaborators: Fundacin Biomedica Galicia Sur
Conditions
(from sponsor)		 Depressive Symptoms, Cognitive Impairment
Related terms Breast Neoplasms, Cognitive Dysfunction, Depression
Enrollment 82 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov