<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04450186</url>
  </required_header>
  <id_info>
    <org_study_id>35RC19_9750_NEUROFEEDEP</org_study_id>
    <secondary_id>2019-A02877-50</secondary_id>
    <nct_id>NCT04450186</nct_id>
  </id_info>
  <brief_title>Study Pilot - Hybrid EEG/fMRI Neurofeedback in Depressed Patients</brief_title>
  <acronym>NEUROFEEDEP</acronym>
  <official_title>Study Pilot - Hybrid EEG/fMRI Neurofeedback in Depressed Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cognitive impairment is a common residual symptom after a depressive episode and expose&#xD;
      patients to a risk of relapsing or therapeutic resistance.&#xD;
&#xD;
      Neurofeedback (using ElectroEncephaloGraphy - EEG or functional Magnetic Resonance Imaging -&#xD;
      fMRI) allows patients to self-regulate their cerebral activity, which is supposedly provided&#xD;
      through an intelligible and motivating feedback.&#xD;
&#xD;
      Recent results exhibited clinical improvement in depressed patients who underwent a fMRI&#xD;
      neurofeedback protocol targeting the amygdala. Furthermore, prefrontal alpha activity was&#xD;
      temporally correlated to variations of the BOLD signal in the amygdala. Simultaneous fMRI/EEG&#xD;
      neurofeedback is hypothesized to potentialize its antidepressant effect.&#xD;
&#xD;
      Our objective will be to test this assumption by conducting a double-blind randomized trial,&#xD;
      and to prove the superiority of bimodal fMRI/EEG neurofeedback over fMRI neurofeedback alone&#xD;
      in depressed patients.&#xD;
&#xD;
      An original visual feedback will be provided and validated beforehand by a pilot study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 10, 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">August 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>EEG power in alpha band</measure>
    <time_frame>day 1</time_frame>
    <description>Measurement by an enregistrement in EEG</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cerebral activation in fMRI</measure>
    <time_frame>day 1</time_frame>
    <description>Measurement by an enregistrement in fMRI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technology prone behaviour</measure>
    <time_frame>day 1</time_frame>
    <description>Measurement by Locus of Control Related to Technology (LCRT) (Beier, 2004, French translation Chikhi, 2017) :&#xD;
Description : Subjective 5-point Likert scale. 8 questions. Self-report.&#xD;
Minimal score : 8&#xD;
Maximal score: 40&#xD;
Interpretation : Assessment of the affinity to technology (higher score - better handling). No cut-off.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxious personality traits</measure>
    <time_frame>day 1</time_frame>
    <description>Measurement by State Trait Anxiety Inventory (STAI - Y) (Spielberger, 1983, French translation Spielberger 1993)&#xD;
Description : 4-point Likert scale. 40 questions. Self report.&#xD;
Two parts : State-anxiety (20 questions) and Trait-anxiety (20 questions)&#xD;
Minimal score : 20&#xD;
Maximal score : 80&#xD;
Interpretation : &gt; 65 - very high anxiety, 56-65 - high, 46-55 - average, 36-45 - low, &lt; 35 - very low</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mindfulness skills</measure>
    <time_frame>day 1</time_frame>
    <description>Measurement by Five Facets Mindfulness Questionnaire (FFMQ) (Baer, 2006, French translation Heeren, 2011)&#xD;
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&#xD;
Minimal score : 39&#xD;
Maximal score : 195&#xD;
Interpretation : Measure of the tendency to be mindful in daily life (higher score - mindful traits). No cut-off.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>EEG/fMRI neurofeedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy volunteers</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EEG/fMRI neurofeedback</intervention_name>
    <description>EEG/fMRI neurofeedback</description>
    <arm_group_label>EEG/fMRI neurofeedback</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged 18 to 65 years old&#xD;
&#xD;
          2. Signature of an informed consent after being given clear and loyal oral and written&#xD;
             information&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Related to the volunteer&#xD;
&#xD;
          1. Prior experience of a neurofeedback task&#xD;
&#xD;
             Related to the MRI&#xD;
&#xD;
          2. Implanted cardiac pacemaker of defibrillator&#xD;
&#xD;
          3. Brain aneurysm clip&#xD;
&#xD;
          4. Cochlear implant&#xD;
&#xD;
          5. Ocular on encephalic metallic foreign body&#xD;
&#xD;
          6. Endoprothesis implanted for less than 4 weeks and ostheosynthesis device implanted for&#xD;
             less than 6 weeks.&#xD;
&#xD;
          7. Claustrophobia&#xD;
&#xD;
             Other criteria&#xD;
&#xD;
          8. Unstable hemodynamic status&#xD;
&#xD;
          9. Acute respiratory failure&#xD;
&#xD;
         10. Alteration of general state or continuous monitoring requirement&#xD;
&#xD;
         11. Other psychiatric condition (DSM-5) such as schizophrenia, substance abuse…&#xD;
&#xD;
         12. Neurological condition or diagnosis of dementia in medical history&#xD;
&#xD;
         13. Undergoing treatment by benzodiazepines or anticonvulsants prescribed less than a&#xD;
             month prior to inclusion&#xD;
&#xD;
         14. Undergoing treatment influencing the blood flow prescribed less than three weeks prior&#xD;
             to inclusion&#xD;
&#xD;
         15. Protected person (adults legally protected (under judicial protection, guardianship or&#xD;
             supervision), person deprived of their liberty, pregnant woman, lactating woman and&#xD;
             minor)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Marie Batail</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Rennes</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nicolas Mevel</last_name>
    <phone>02 99 28 25 55</phone>
    <email>dri@chu-rennes.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anne Ganivet</last_name>
    <phone>02 99 28 25 55</phone>
    <email>anne.ganivet@chu-rennes.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Marie Batail</last_name>
    </contact>
    <investigator>
      <last_name>Pauline Rolland</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>May 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>October 19, 2020</last_update_submitted>
  <last_update_submitted_qc>October 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neurofeedback</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04450186
org study id: 35RC19_9750_NEUROFEEDEP
secondary id: 2019-A02877-50
nct id: NCT04450186
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: EEG power in alpha band
time frame: day 1
description: Measurement by an enregistrement in EEG
measure: Cerebral activation in fMRI
time frame: day 1
description: Measurement by an enregistrement in fMRI
measure: Technology prone behaviour
time frame: day 1
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.
measure: Anxious personality traits
time frame: day 1
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
measure: Mindfulness skills
time frame: day 1
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.
arm group label: EEG/fMRI neurofeedback
arm group type: Experimental
description: Healthy volunteers
intervention type: Other
intervention name: EEG/fMRI neurofeedback
description: EEG/fMRI neurofeedback
arm group label: EEG/fMRI neurofeedback
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jean-Marie Batail
role: Principal Investigator
affiliation: CHU Rennes
last name: Nicolas Mevel
phone: 02 99 28 25 55
email: dri@chu-rennes.fr
last name: Anne Ganivet
phone: 02 99 28 25 55
email: anne.ganivet@chu-rennes.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Depression
sharing ipd: No