Non-Invasive Brain Stimulation and Cognitive Training for Depressive Symptomatology Related to Breast Cancer (ONCODEP)
ONCODEP
Intervention With Non-Invasive Brain Stimulation and Cognitive Training for Depressive Symptomatology Associated With Breast Cancer (ONCODEP)
2 other identifiers
interventional
82
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2023
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2023
CompletedFirst Posted
Study publicly available on registry
September 26, 2023
CompletedStudy Start
First participant enrolled
September 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedJuly 20, 2025
July 1, 2025
1.9 years
September 11, 2023
July 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Beck Depression Inventory- Fast Screen (BDI-FS)
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.
pre-, post- intervention (15 days) and follow-up (1,3,6 months)
Secondary Outcomes (2)
Patient Reported Outcomes Measurement Information System (PROMIS) Cognitive Function 8a
pre-, post- intervention (15 days) and follow-up (1,3,6 months)
Montreal Cognitive Assessment (MoCA)
pre-, post- intervention (15 days) and follow-up (1month).
Other Outcomes (14)
Digit Span Test (forward and backward) (Barcelona Test-Revised)
pre-, post- intervention (15 days) and follow up (1 month)
Spain-Complutense Verbal Learning Test (TAVEC)
pre-, follow-up (1 month)
Verbal fluency test (NEURONORMA Project)
pre-, post- intervention (15 days) and follow up (1 month)
- +11 more other outcomes
Study Arms (4)
Online Cognitive Training
ACTIVE COMPARATOR15 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.
Transcranial Direct Current Stimulation
EXPERIMENTALtDCS: 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.
Transcranial Alternating Current Stimulation
EXPERIMENTALtACS: 15 daily sessions targeting left DLPFC (anodes: F3, F4; frequency: 4Hz -theta-tACS-). 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. Participant will be performing the OCT during stimulation.
tES sham
SHAM COMPARATOR15 sessions of sham stimulation for 20 minutes, acting as a placebo control group. The electrode montage will be the same as that used in the active neuromodulation conditions: tDCS for half of the participants and tACS for the other half. In this sham stimulation condition, the current will only be delivered for a 15 seconds, at the ramp-up and ramp-down times at the beginning and end of the session. The OCT will also be the same as those performed by participants in the other groups
Interventions
tDCS+OCT
tACS+OCT
OCT
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Santiago de Compostela
Santiago de Compostela, A Coruña, 15701, Spain
Fundación Biomédica Galicia Sur
Vigo, Pontevedra, 36312, Spain
Related Publications (5)
Lefaucheur 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: 27866120BACKGROUNDMoffa 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: 31837388BACKGROUNDRodella 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: 34156651BACKGROUNDCheng 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: 35091967BACKGROUNDGaynor 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: 32353419BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- In this study, a double-blind design will be used, since the device used for the tDCS/tACS intervention allows for total blinding. The patient and the researchers involved in treatment will be blinded to the group of treatment (except for the OCT group). Evaluation and data analysis will be blinded to group assignment until the participant has completed the study. Only the members of the research team in charge of generating the randomization list will have access to the patient's intervention status.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- University Professor
Study Record Dates
First Submitted
September 11, 2023
First Posted
September 26, 2023
Study Start
September 27, 2023
Primary Completion
September 1, 2025
Study Completion
September 1, 2025
Last Updated
July 20, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share