Clinical trial · Interventional
Non-Invasive Brain Stimulation and Cognitive Training for Depressive Symptomatology Related to Breast Cancer (ONCODEP)
Intervention With Non-Invasive Brain Stimulation and Cognitive Training for Depressive Symptomatology Associated With Breast Cancer (ONCODEP)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cognitive Impairment | — | UNRESOLVED | — |
| Depressive Symptoms | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Online Cognitive Training | Device | — | UNRESOLVED |
| tES sham | Device | — | UNRESOLVED |
| Transcranial Alternating Current Stimulation | Device | — | UNRESOLVED |
| Transcranial Direct Current Stimulation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Online Cognitive Training
- description
- 15 sessions of 20 minutes each one.Training will focus on the stimulation of several cognitive functions (attention, memory and learning, language, executive functions,processing speed, etc) through different exercises. The sessions will be adjusted to the individual performance level. The participant will perform these exercises from their computer or tablet, through the NeuronUp2GO platform, and the researcher will have access to all the session data.
- interventionNames
- Device: Online Cognitive Training
- type
- EXPERIMENTAL
- label
- Transcranial Direct Current Stimulation
- description
- tDCS: 15 daily sessions targeting left DLPFC (anode: F3, cathode: Fp2) Current intensity will be set at 2mA and will be applied for 20 minutes, with 15-second ramps up and down at the beginning and end of the stimulation period. During the session, the participant will be performing the OCT.
- interventionNames
- Device: Transcranial Direct Current Stimulation
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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)
References
Publications (5)
- BACKGROUNDLefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29. PMID 27866120
- BACKGROUNDMoffa AH, Martin D, Alonzo A, Bennabi D, Blumberger DM, Bensenor IM, Daskalakis Z, Fregni F, Haffen E, Lisanby SH, Padberg F, Palm U, Razza LB, Sampaio-Jr B, Loo C, Brunoni AR. Efficacy and acceptability of transcranial direct current stimulation (tDCS) for major depressive disorder: An individual patient data meta-analysis. Prog Neuropsychopharmacol Biol Psychiatry. 2020 Apr 20;99:109836. doi: 10.1016/j.pnpbp.2019.109836. Epub 2019 Dec 16. PMID 31837388
- BACKGROUNDRodella C, Bernini S, Panzarasa S, Sinforiani E, Picascia M, Quaglini S, Cavallini E, Vecchi T, Tassorelli C, Bottiroli S. A double-blind randomized controlled trial combining cognitive training (CoRe) and neurostimulation (tDCS) in the early stages of cognitive impairment. Aging Clin Exp Res. 2022 Jan;34(1):73-83. doi: 10.1007/s40520-021-01912-0. Epub 2021 Jun 22. PMID 34156651
- BACKGROUNDCheng ASK, Wang X, Niu N, Liang M, Zeng Y. Neuropsychological Interventions for Cancer-Related Cognitive Impairment: A Network Meta-Analysis of Randomized Controlled Trials. Neuropsychol Rev. 2022 Dec;32(4):893-905. doi: 10.1007/s11065-021-09532-1. Epub 2022 Jan 29. PMID 35091967
- BACKGROUNDGaynor AM, Pergolizzi D, Alici Y, Ryan E, McNeal K, Ahles TA, Root JC. Impact of transcranial direct current stimulation on sustained attention in breast cancer survivors: Evidence for feasibility, tolerability, and initial efficacy. Brain Stimul. 2020 Jul-Aug;13(4):1108-1116. doi: 10.1016/j.brs.2020.04.013. Epub 2020 Apr 27. PMID 32353419