Viewing Study NCT06053775



Ignite Creation Date: 2024-05-06 @ 7:33 PM
Last Modification Date: 2024-10-26 @ 3:09 PM
Study NCT ID: NCT06053775
Status: RECRUITING
Last Update Posted: 2023-11-29
First Post: 2023-09-11

Brief Title: Non-Invasive Brain Stimulation and Cognitive Training for Depressive Symptomatology Related to Breast Cancer ONCODEP
Sponsor: University of Santiago de Compostela
Organization: University of Santiago de Compostela

Study Overview

Official Title: Intervention With Non-Invasive Brain Stimulation and Cognitive Training for Depressive Symptomatology Associated With Breast Cancer ONCODEP
Status: RECRUITING
Status Verified Date: 2023-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ONCODEP
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 tDCStACS 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 tDCStACS active or sham

In addition saliva samples will be collected to identify bomarkers predictive of treatment efficacy
Detailed Description: This study is aimed at analyzing the feasibility and therapeutic efficacy of a home-based treatment using tDCStACS and an OCT program to treat depressive symptomatology primary outcome variable associated with breast cancerThe 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 relativescaregivers 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 inclusionexclusion 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 platformPossible 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-MSMS 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 ICHGood 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 2016679 and with the Organic Law 32018 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 142007 and RD 1716201

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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: True
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: True
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
FPU2100082 OTHER_GRANT Ayudas para contratos predoctorales FPU 2021 None