Study Pilot - Hybrid EEG/fMRI Neurofeedback in Depressed Patients (NEUROFEEDEP)

Rennes University Hospital

Status: Unknown

Conditions: Depression

Treatments: Other: EEG/fMRI neurofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT04450186

2019-A02877-50 (Other Identifier)

35RC19_9750_NEUROFEEDEP

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

EEG/fMRI neurofeedback

Experimental group

Description:

Healthy volunteers

Treatment:

Other: EEG/fMRI neurofeedback