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Study Pilot - Hybrid EEG/fMRI Neurofeedback in Depressed Patients (NEUROFEEDEP)

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
EEG/fMRI neurofeedback
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Neurofeedback

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • CHURecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EEG/fMRI neurofeedback

Arm Description

Healthy volunteers

Outcomes

Primary Outcome Measures

EEG power in alpha band
Measurement by an enregistrement in EEG
Cerebral activation in fMRI
Measurement by an enregistrement in fMRI

Secondary Outcome Measures

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.
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
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.

Full Information

First Posted
May 12, 2020
Last Updated
October 19, 2020
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04450186
Brief Title
Study Pilot - Hybrid EEG/fMRI Neurofeedback in Depressed Patients
Acronym
NEUROFEEDEP
Official Title
Study Pilot - Hybrid EEG/fMRI Neurofeedback in Depressed Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 10, 2020 (Actual)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Neurofeedback

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EEG/fMRI neurofeedback
Arm Type
Experimental
Arm Description
Healthy volunteers
Intervention Type
Other
Intervention Name(s)
EEG/fMRI neurofeedback
Intervention Description
EEG/fMRI neurofeedback
Primary Outcome Measure Information:
Title
EEG power in alpha band
Description
Measurement by an enregistrement in EEG
Time Frame
day 1
Title
Cerebral activation in fMRI
Description
Measurement by an enregistrement in fMRI
Time Frame
day 1
Secondary Outcome Measure Information:
Title
Technology prone behaviour
Description
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.
Time Frame
day 1
Title
Anxious personality traits
Description
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
Time Frame
day 1
Title
Mindfulness skills
Description
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.
Time Frame
day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas Mevel
Phone
02 99 28 25 55
Email
dri@chu-rennes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Ganivet
Phone
02 99 28 25 55
Email
anne.ganivet@chu-rennes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Marie Batail
Organizational Affiliation
CHU Rennes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU
City
Rennes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Marie Batail
First Name & Middle Initial & Last Name & Degree
Pauline Rolland

12. IPD Sharing Statement

Plan to Share IPD
No

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Study Pilot - Hybrid EEG/fMRI Neurofeedback in Depressed Patients

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