Depression
Conditions
Keywords
Neurofeedback
Brief summary
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.
Interventions
OTHEREEG/fMRI neurofeedback
EEG/fMRI neurofeedback
Sponsors
Rennes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EEG power in alpha band | day 1 | Measurement by an enregistrement in EEG |
| Cerebral activation in fMRI | day 1 | Measurement by an enregistrement in fMRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technology prone behaviour | day 1 | 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. |
| Anxious personality traits | day 1 | 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 |
| Mindfulness skills | day 1 | 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. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORJean-Marie Batail
Rennes University Hospital
Outcome results
None listed