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Completed

NCT Number: NCT04450186

Study Pilot - Hybrid EEG/fMRI Neurofeedback in Depressed Patients

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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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU

Rennes, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 to 65 years old
  • Signature of an informed consent after being given clear and loyal oral and written information

Exclusion criteria

Related to the volunteer

  • Prior experience of a neurofeedback task

Related to the MRI

  • Implanted cardiac pacemaker of defibrillator
  • Brain aneurysm clip
  • Cochlear implant
  • Ocular on encephalic metallic foreign body
  • Endoprothesis implanted for less than 4 weeks and ostheosynthesis device implanted for less than 6 weeks.
  • Claustrophobia

Other criteria

  • Unstable hemodynamic status
  • Acute respiratory failure
  • Alteration of general state or continuous monitoring requirement
  • Other psychiatric condition (DSM-5) such as schizophrenia, substance abuse…
  • Neurological condition or diagnosis of dementia in medical history
  • Undergoing treatment by benzodiazepines or anticonvulsants prescribed less than a month prior to inclusion
  • Undergoing treatment influencing the blood flow prescribed less than three weeks prior to inclusion
  • Protected person (adults legally protected (under judicial protection, guardianship or supervision), person deprived of their liberty, pregnant woman, lactating woman and minor)

Treatment and study plan

EEG/fMRI neurofeedback

Other

EEG/fMRI neurofeedback

Primary outcomes

  1. EEG power in alpha band

    Time frame: day 1

    Measurement by an enregistrement in EEG

  2. Cerebral activation in fMRI

    Time frame: day 1

    Measurement by an enregistrement in fMRI

Secondary outcomes

  1. Technology prone behaviour

    Time frame: day 1

    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.

  2. Anxious personality traits

    Time frame: day 1

    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

  3. Mindfulness skills

    Time frame: day 1

    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.

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: NEUROFEEDEP

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jun 29, 2020
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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