Study Pilot - Hybrid EEG/fMRI Neurofeedback in Depressed Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-10

Study Completion Date

2021-12-31

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.

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Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EEG/fMRI neurofeedback

Healthy volunteers

Group Type EXPERIMENTAL

EEG/fMRI neurofeedback

Intervention Type OTHER

EEG/fMRI neurofeedback

Interventions

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EEG/fMRI neurofeedback

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes