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

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.

Study Overview

• Status: Unknown
• Conditions: Depression
• Intervention / Treatment: Other: EEG/fMRI neurofeedback

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France
    • Recruiting
    • CHU
    • Contact: Jean-Marie BATAIL
    • Sub-Investigator: Pauline Rolland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: EEG/fMRI neurofeedback; Healthy volunteers	Other: EEG/fMRI neurofeedback; EEG/fMRI neurofeedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG power in alpha band	Measurement by an enregistrement in EEG	day 1
Cerebral activation in fMRI	Measurement by an enregistrement in fMRI	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technology prone behaviour	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.	day 1
Anxious personality traits	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	day 1
Mindfulness skills	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.	day 1

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Jean-Marie Batail, Chu Rennes

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 10, 2020
• Primary Completion (ANTICIPATED): August 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: June 26, 2020
• First Posted (ACTUAL): June 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Neurofeedback
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 35RC19_9750_NEUROFEEDEP; 2019-A02877-50 (OTHER: N° ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No