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)
Beck Depression Inventory- Fast Screen (BDI-FS) — pre-, post- intervention (15 days) and follow-up (1,3,6 months) Screening of depressive symptoms in medical patients (7 items, scored on a Likert scale from 0 to 3). BDI-FS minimum and maximum values range from 0 to 21, with higher scores meaning more depressive symptomatology.
Trial sites (2)
Facility
City
Region
Status
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
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.
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