🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity ◆ Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing ◆ Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich ◆ Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery ◆ Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma ◆ Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide ◆ The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany ◆ Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact ◆ Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity ◆ Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing ◆ Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich ◆ Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery ◆ Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma ◆ Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide ◆ The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany ◆ Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact ◆
Clinical Trials in Spain / NCT06053775
Active, not recruiting Not applicable

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

NCT06053775 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2023-09-27
Last updated
2025-07-20

Condition(s) studied

Depressive SymptomsCognitive Impairment

Investigational drug(s) / intervention(s)

Transcranial Direct Current StimulationTranscranial Alternating Current StimulationtES shamOnline Cognitive Training

Transcranial Direct Current Stimulation: tDCS+OCT

Transcranial Alternating Current Stimulation: tACS+OCT

tES sham: tES sham + OCT

Online Cognitive Training: OCT

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.

Eligibility

Sex
FEMALE
Min age
30 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of breast cancer in early stages (life expectancy greater than 12 months). * Patients who are receiving or have finished (maximum 6 months prior to participation in the participating in the study) some type of oncological treatment (Chemotherapy, Radiotherapy, Immunotherapy, Hormonal Therapy). * Patients whose mother tongue is Galician or Spanish. * Ability to give informed consent. * Present depressive symptomatology: score of 4 or higher in the BDI-FS. * Ability to use WhastApp * Have access to some technology (desktop computer, laptop or tablet) and the Internet (Firefox or Chrome browsers). Exclusion Criteria: * Pregnant or breastfeeding women. * Patients with metastasis. * Patients with a mental health disorder (major depressive disorder, bipolar,anxious, psychotic...) diagnosed by a psychiatrist prior to the oncological process. * Patients with a history of cognitive impairment or dementia prior to the oncologic process. oncological process. * Patients with a history of neurosurgery, cortical lesions or neurological alterations prior to the oncological process. * Patients with history or current consumption of non-prescribed drugs. * Patients with the following medication regimen: mood stabilizers, antipsychotics, anticonvulsants, l-dopa, rivastigmine, dextromethorphan, flunarizine, sulpiride, use of benzodiazepines (excluding long half-life benzodiazepines (Bromazepam, Diazepam) on a continuous/habitual basis,Alprazolam \>1mg per day, Lorazepam \>2mg per day). * Patients taking antidepressant medication should have a stable regimen ( same medication at the same dose for a minimum of four weeks prior to entering the study.The regimen with antidepressant drugs or drugs used as treatment to improve cognition should be kept stable during the entire participation (until the follow-up evaluation has been performed). * Patients unable to complete a neuropsychological examination. * Patients who are participating in a research study/clinical trial with drugs. * Patients who present any condition contraindicated to undergo tES (intracranial ferromagnetic devices or implanted stimulators; history of active epilepsy; history of neurosurgery, traumatic brain injury with loss of brainwith loss of consciousness and/or cortical lesion) (Antal et al., 2017)

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
University of Santiago de Compostela Santiago de Compostela A Coruña
Fundación Biomédica Galicia Sur Vigo Pontevedra

More University of Santiago de Compostela trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06053775 on ClinicalTrials.gov ↗ ← All trials in Spain