Study Pilot - Hybrid EEG/fMRI Neurofeedback in Depressed Patients

Not Applicable

• Conditions: Depression
• Interventions: Other: EEG/fMRI neurofeedback

• Registration Number: NCT04450186
• Lead Sponsor: Rennes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-06-26
• Study First Posted: 2020-06-29
• Study Start: 2020-08-10
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-19
• Last Update Posted: 2020-10-22
• Primary Completion: 2021-08
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EEG/fMRI neurofeedback	EEG/fMRI neurofeedback	Healthy volunteers

Primary Outcome Measures

Name	Time	Method
Cerebral activation in fMRI	day 1	Measurement by an enregistrement in fMRI
EEG power in alpha band	day 1	Measurement by an enregistrement in EEG

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

CHU; 🇫🇷 Rennes, France