Study Pilot - Hybrid EEG/fMRI Neurofeedback in Depressed Patients

Study Overview
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Brief Summary
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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.

Official Title
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Study Pilot - Hybrid EEG/fMRI Neurofeedback in Depressed Patients

Conditions
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Depression

Intervention / Treatment
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* Other: EEG/fMRI neurofeedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 to 65 years old Signature of an informed consent after being given clear and loyal oral and written information Exclusion Criteria: Related to the volunteer Prior experience of a neurofeedback task Related to the MRI Implanted cardiac pacemaker of defibrillator Brain aneurysm clip Cochlear implant Ocular on encephalic metallic foreign body Endoprothesis implanted for less than 4 weeks and ostheosynthesis device implanted for less than 6 weeks. Claustrophobia Other criteria Unstable hemodynamic status Acute respiratory failure Alteration of general state or continuous monitoring requirement Other psychiatric condition (DSM-5) such as schizophrenia, substance abuse… Neurological condition or diagnosis of dementia in medical history Undergoing treatment by benzodiazepines or anticonvulsants prescribed less than a month prior to inclusion Undergoing treatment influencing the blood flow prescribed less than three weeks prior to inclusion Protected person (adults legally protected (under judicial protection, guardianship or supervision), person deprived of their liberty, pregnant woman, lactating woman and minor)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EEG/fMRI neurofeedback<br>Healthy volunteers | Other: EEG/fMRI neurofeedback<br>* EEG/fMRI neurofeedback<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG power in alpha band | Measurement by an enregistrement in EEG | day 1 | 
| Cerebral activation in fMRI | Measurement by an enregistrement in fMRI | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technology prone behaviour | Measurement by Locus of Control Related to Technology (LCRT) (Beier, 2004, French translation Chikhi, 2017) : Description : Subjective 5-point Likert scale. 8 questions. Self-report. Minimal score : 8 Maximal score: 40 Interpretation : Assessment of the affinity to technology (higher score - better handling). No cut-off. | day 1 | 
| Anxious personality traits | Measurement by State Trait Anxiety Inventory (STAI - Y) (Spielberger, 1983, French translation Spielberger 1993) Description : 4-point Likert scale. 40 questions. Self report. Two parts : State-anxiety (20 questions) and Trait-anxiety (20 questions) Minimal score : 20 Maximal score : 80 Interpretation : > 65 - very high anxiety, 56-65 - high, 46-55 - average, 36-45 - low, < 35 - very low | day 1 | 
| Mindfulness skills | Measurement by Five Facets Mindfulness Questionnaire (FFMQ) (Baer, 2006, French translation Heeren, 2011) Description : 5-point Likert scale. 39 questions. Self-report. Five facets : Observing, Describing, Acting with awareness, Non-judging of inner experience, Non-reactivity to inner experience Minimal score : 39 Maximal score : 195 Interpretation : Measure of the tendency to be mindful in daily life (higher score - mindful traits). No cut-off. | day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurofeedback