Clinical trial NCT04450186: Study Pilot - Hybrid EEG/fMRI Neurofeedback in Depressed Patients
Official title: Study Pilot - Hybrid EEG/fMRI Neurofeedback in Depressed Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: Neurofeedback
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2020-06-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: EEG power in alpha band
timeFrame: day 1
measure: Cerebral activation in fMRI
timeFrame: day 1
Secondary outcomes:
measure: Technology prone behaviour
timeFrame: day 1
measure: Anxious personality traits
timeFrame: day 1
measure: Mindfulness skills
timeFrame: day 1
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU
Study officials:
affiliation: CHU Rennes
name: Jean-Marie Batail
role: PRINCIPAL_INVESTIGATOR
References: