DepressionNEUROFEEDEPNCT04450186
Study Pilot - Hybrid EEG/fMRI Neurofeedback in Depressed Patients
A study testing EEG/fMRI neurofeedback in people with Depression, run by Rennes University Hospital at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- EEG/fMRI neurofeedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 10 Aug 2020to 26 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 to 65 years old
- Signature of an informed consent after being given clear and loyal oral and written information
Who cannot join
- Related to the volunteer
- Prior experience of a neurofeedback task
- Related to the MRI
- Implanted cardiac pacemaker of defibrillator
- Brain aneurysm clip
- Cochlear implant
Show all 18Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Depression
- Being tested
- EEG/fMRI neurofeedback
- Keywords
- Neurofeedback
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG/fMRI neurofeedbackOther
EEG/fMRI neurofeedback
| Study group | Role | What they receive |
|---|---|---|
| EEG/fMRI neurofeedback | Experimental | Healthy volunteers Receives: Other: EEG/fMRI neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG power in alpha band
Measurement by an enregistrement in EEG
Measured: day 1
Cerebral activation in fMRI
Measurement by an enregistrement in fMRI
Measured: day 1
Secondary outcomes (3)
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.
Measured: 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
Measured: 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.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start10 Aug 2020
- Primary completion26 Apr 2021
- Study completion26 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marie Batail, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450186
- Sponsor's protocol ID
- 35RC19_9750_NEUROFEEDEP
- Other IDs
- 2019-A02877-50
- Acronym
- NEUROFEEDEP
- Status last verified
- Jun 2026
- First submitted
- 12 May 2020
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Pilot - Hybrid EEG/fMRI Neurofeedback in Depressed Patients
- ClinicalTrials.gov ID
- NCT04450186
- Acronym / sponsor ID
- NEUROFEEDEP / 35RC19_9750_NEUROFEEDEP
- Conditions
- Depression
- Keywords
- Neurofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 26 Apr 2022 (actual)
- First posted
- 29 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EEG/fMRI neurofeedback | Experimental | Other: EEG/fMRI neurofeedbackHealthy volunteers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18 to 65 years old
- Signature of an informed consent after being given clear and loyal oral and written information
Key exclusion criteria (18 listed)
- Related to the volunteer
- Prior experience of a neurofeedback task
- Related to the MRI
- Implanted cardiac pacemaker of defibrillator
- Brain aneurysm clip
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEG/fMRI neurofeedbackEEG/fMRI neurofeedback | Other | EEG/fMRI neurofeedback |
Primary outcome
EEG power in alpha band
Time frame: day 1
Measurement by an enregistrement in EEG
Cerebral activation in fMRI
Time frame: day 1
Measurement by an enregistrement in fMRI
3 secondary outcomes
Technology prone behaviour
Time frame: day 1
Anxious personality traits
Time frame: day 1
Mindfulness skills
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Marie Batail principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG/fMRI neurofeedback in people with Depression, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG power in alpha band (time frame: day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.