Study Pilot - Hybrid EEG/fMRI Neurofeedback in Depressed... | NCT04450186

Studies
Study Pilot - Hybrid EEG/fMRI Neurofeedback in Depressed Patients

NCT04450186

Sponsor

Rennes University Hospital

Status

Completed

Last Update Posted

Jun 12, 2026Actual

Enrollment

31Actual

Phase

Not Applicable

Conditions

Depression

Interventions

EEG/fMRI neurofeedback

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2019-A02877-50	Other Identifier	N° ID-RCB

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 10, 2020Actual

Primary Completion Date

Apr 26, 2021Actual

Completion Date

Apr 26, 2022Actual

First Submitted Date

May 12, 2020

First Submission Date that Met QC Criteria

Jun 26, 2020

First Posted Date

Jun 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2026

Last Update Posted Date

Jun 12, 2026Actual

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Label	Type	Description	Intervention Names
EEG/fMRI neurofeedback	Experimental	Healthy volunteers	Other: EEG/fMRI neurofeedback

Name	Type	Description	Arm Group Labels	Other Names
EEG/fMRI neurofeedback	Other	EEG/fMRI neurofeedback	EEG/fMRI neurofeedback

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior