NEUROFEEDEPStudy Pilot - Hybrid EEG/fMRI Neurofeedback in Depressed Patients
EEG/fMRI neurofeedback
Behavior
+ Behavioral Symptoms
+ Depression
Treatment Study
Summary
Study start date: August 10, 2020
Actual date on which the first participant was enrolled.Cognitive impairment is a common residual symptom after a depressive episode and expose patients to a risk of relapsing or therapeutic resistance. Neurofeedback (using ElectroEncephaloGraphy - EEG or functional Magnetic Resonance Imaging - fMRI) allows patients to self-regulate their cerebral activity, which is supposedly provided through an intelligible and motivating feedback. Recent results exhibited clinical improvement in depressed patients who underwent a fMRI neurofeedback protocol targeting the amygdala. Furthermore, prefrontal alpha activity was temporally correlated to variations of the BOLD signal in the amygdala. Simultaneous fMRI/EEG neurofeedback is hypothesized to potentialize its antidepressant effect. Our objective will be to test this assumption by conducting a double-blind randomized trial, and to prove the superiority of bimodal fMRI/EEG neurofeedback over fMRI neurofeedback alone in depressed patients. An original visual feedback will be provided and validated beforehand by a pilot study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Aged 18 to 65 years old 2. Signature of an informed consent after being given clear and loyal oral and written information Exclusion Criteria: Related to the volunteer 1. Prior experience of a neurofeedback task Related to the MRI 2. Implanted cardiac pacemaker of defibrillator 3. Brain aneurysm clip 4. Cochlear implant 5. Ocular on encephalic metallic foreign body 6. Endoprothesis implanted for less than 4 weeks and ostheosynthesis device implanted for less than 6 weeks. 7. Claustrophobia Other criteria 8. Unstable hemodynamic status 9. Acute respiratory failure 10. Alteration of general state or continuous monitoring requirement 11. Other psychiatric condition (DSM-5) such as schizophrenia, substance abuse… 12. Neurological condition or diagnosis of dementia in medical history 13. Undergoing treatment by benzodiazepines or anticonvulsants prescribed less than a month prior to inclusion 14. Undergoing treatment influencing the blood flow prescribed less than three weeks prior to inclusion 15. Protected person (adults legally protected (under judicial protection, guardianship or supervision), person deprived of their liberty, pregnant woman, lactating woman and minor)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location