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

NCT06053775 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2025-07-20

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Transcranial Direct Current Stimulation

tDCS+OCT

DEVICE

Transcranial Alternating Current Stimulation

tACS+OCT

DEVICE

tES sham

tES sham + OCT

DEVICE

Online Cognitive Training

OCT

Sponsors & Collaborators

  • Fundacin Biomedica Galicia Sur

    collaborator OTHER

  • University of Santiago de Compostela

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-27
Primary Completion
2025-09-30
Completion
2025-09-30
FDA Device
Yes

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06053775 on ClinicalTrials.gov