Study Pilot - Hybrid EEG/fMRI Neurofeedback in Depressed Patients

Depression Clinical Trial

— NEUROFEEDEP  

Official title:

Study Pilot - Hybrid EEG/fMRI Neurofeedback in Depressed Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04450186
• Other study ID #: 35RC19_9750_NEUROFEEDEP
• Secondary ID: 2019-A02877-50
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2020
• Est. completion date: December 2021

Study information

• Verified date: October 2020
• Source: Rennes University Hospital
• Contact: Nicolas Mevel
• Phone: 02 99 28 25 55
• Email: dri[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression

Intervention

Other:
• EEG/fMRI neurofeedback
EEG/fMRI neurofeedback

Locations

Country	Name	City	State
France	CHU	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG power in alpha band	Measurement by an enregistrement in EEG	day 1
Primary	Cerebral activation in fMRI	Measurement by an enregistrement in fMRI	day 1
Secondary	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
Secondary	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
Secondary	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