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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 30 Years - 65 Years
Gender Female
More Inclusion & Exclusion Criteria

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 history of psychiatric symptomatology (depressive disorder, bipolar,anxious, psychotic.
..) 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06053775
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Santiago de Compostela
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Spain
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Depressive Symptoms, Cognitive Impairment
Study Website: View Trial Website
Additional Details

This study is aimed at analyzing the feasibility and therapeutic efficacy of a home-based treatment using tDCS/tACS and an OCT program to treat depressive symptomatology (primary outcome variable) associated with breast cancer.The effect of the intervention on the patients' cognitive functioning (secondary outcome variable) will be also studied. In addition, saliva biomarkers and other clinical variables will be analyzed to determine whether they are related to the response to treatment. Finally, the impact of the intervention on the burden of the relatives/caregivers will be studied. Oncology Units of the Galician Health Service will be contacted for recruitment. Oncologists will review whether patients meet the inclusion criteria and none of the exclusion criteria. If so, patients will be given an information flyer and will contact the research team to receive more information and, if they wish, to participate in the study. If patients are interested in participating, researchers will contact them to confirm the inclusion/exclusion criteria and participants will be invited to the first face-to-face session. In this session, informed consent will be signed, pre-treatment neuropsychological assessment will be performed, medical data will be reviewed, and a saliva sample will be collected. After collecting this data, the first treatment session will take place in the presence of the researcher. The type of treatment each patient will receive (OCT, tDCS active+ OCT, tACS active+ OCT or sham neurostimulation+ OCT. ) will be chosen randomly, using a randomization list. After that, each patient will undergo 14 sessions, daily, at home. The tES devices (Soterix Medical Inc) have been designed for home use and allow the application of the stimulation by the patient himself, while being monitored by the researcher. The OCT will be delivered through NeuronUp2GO platform.Possible adverse effects associated with neurostimulation (which are mild and transitory) and other variables that may affect its efficacy (medication diary, caffeine intake...) will be monitored daily. Finally, a post-treatment assessment will be carried out 15 days after the start of treatment and a follow-up assessment will be carried out 1, 3 and 6 months after the end of treatment. The 15-day and 1 month assessments will be the same as the pre-treatment (questionnaries and neuropsychological test). The follow-ups at 3 and 6 months will be done online, by filling in questionnaires. Both the treatment administration and analysis of the results will be blinded. First, descriptive analyses will be performed on the sociodemographic and clinical data. To evaluate the efficacy of the treatments on depressive symptomatology and subjective cognitive complaints, ANOVAs will be calculated under classical and Bayesian statistical frameworks, with Group (4 arms) as inter-participant factor and Time (pre, post, 1, 3 and 6 months follow-up) as intra-participant factor, following an Intention-to-Treat approach (including possible missing data after randomization). ANOVAs will also be calculalted with with Group (4 arms) as inter-participant factor and Time (pre, post, 1 month follow-up) as intra-participant factor to calculate the efficacy of the treatments on neuropsychological indexes. The possible modulating effect of sociodemograpchic and clinical variables on treatment efficacy will be analyzed. Also, for the clinical validation of the treatments, the analysis of the Minimal Clinically Important Difference (MCID) at short (15 days), medium (1 month) and long term (3 and 6 months) will be included. The difference between the pre- and post-treatment assessment in the primary and secondary variable scores should be equal to or greater than 30%. Proteomic analysis will be performed at the Fundación Biomédica Galicia Sur. The following analysis will be performed: determination of total protein, mass spectrometry and electrophoretic separation of the samples by SDS-PAGE and identification of the bands of interest by Shotgun. The whole sample will be analyzed in liquid mass spectrometer (LC-MS/MS). Linear or logistic regression analysis will be performed to determine the predictive power of the saliva biomarkerson treatment efficacy. Since the present research involves adult humans, it will be conducted under applicable international, EU and national laws and regulations (The Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects; The International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP) Guidelines; the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine; and the UNESCO Universal Declaration on Bioethics and Human Rights (2005). Permission has been obtained from the local IRB committee (CEIm de Galicia) to conduct the study. In terms of data protection, this study complies with the directives of the General Data Protection Regulation (GDPR), approved by the European Commission on April 27, 2016 (EU 2016/679) and with the Organic Law 3/2018, of December 5, 2018, on the Protection of Personal Data and guarantees of digital rights. The storage and treatment of the samples will be carried out in accordance with the Biomedical Research Law 14/2007 and RD 1716/201. Patients' clinical data will be collected in the study-specific data collection notebook using REDCap (Research Electronic Data Capture), a secure web-based application for building and managing online surveys and databases. Data collection will be pseudo-anonymous, protecting the identity of the participant. Only the principal investigator of the entity responsible for data collection (USC) will know the pseudonymization codes. The research team will have access to all coded data collected for the study.

Arms & Interventions

Arms

Active Comparator: Online Cognitive Training

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.

Experimental: Transcranial Direct Current Stimulation

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.

Experimental: Transcranial Alternating Current Stimulation

tACS: 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.

Sham Comparator: tES sham

15 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

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

University of Santiago de Compostela, Santiago De Compostela, A Coruña, Spain

Status

Recruiting

Address

University of Santiago de Compostela

Santiago De Compostela, A Coruña, 15701

Site Contact

María Teresa Carrillo de la Peña, PhD

[email protected]

+34 625 76 32 25

Fundación Biomédica Galicia Sur, Vigo, Pontevedra, Spain

Status

Not yet recruiting

Address

Fundación Biomédica Galicia Sur

Vigo, Pontevedra, 36312

Site Contact

Carlos Spuch Calvar

[email protected]

+34679461538

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