Study Pilot - Hybrid EEG/fMRI Neurofeedback in Depressed Patients
NEUROFEEDEP
2 other identifiers
interventional
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable depression
Started Aug 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2020
CompletedFirst Posted
Study publicly available on registry
June 29, 2020
CompletedStudy Start
First participant enrolled
August 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2022
CompletedJune 12, 2026
June 1, 2026
9 months
May 12, 2020
June 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 (3)
Technology prone behaviour
day 1
Anxious personality traits
day 1
Mindfulness skills
day 1
Study Arms (1)
EEG/fMRI neurofeedback
EXPERIMENTALHealthy volunteers
Interventions
Eligibility Criteria
You may qualify if:
- Aged 18 to 65 years old
- Signature of an informed consent after being given clear and loyal oral and written information
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU
Rennes, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Marie Batail
Rennes University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2020
First Posted
June 29, 2020
Study Start
August 10, 2020
Primary Completion
April 26, 2021
Study Completion
April 26, 2022
Last Updated
June 12, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share