<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/NCT04408521</url>
  </required_header>
  <id_info>
    <org_study_id>2017-01029</org_study_id>
    <secondary_id>SNCTP000002260</secondary_id>
    <nct_id>NCT04408521</nct_id>
  </id_info>
  <brief_title>Effects of a Novel Neurofeedback Protocol on ADHD Subcomponents</brief_title>
  <acronym>NFB@HOME</acronym>
  <official_title>Effect of Long-lasting EEG-Neurofeedback on Attention Control and Impulsivity in Adult Attention-Deficit/Hyperactivity Disorder (ADHD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Geneva</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Geneva, Switzerland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Geneva</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>
      Mounting evidence suggests that closed-loop brain-training, commonly known as neurofeedback&#xD;
      (NFB), may represent a new therapeutic opportunity for patients with Attentional&#xD;
      Deficit/Hyperactivity Disorder (ADHD), which manifests as difficulties with attention and&#xD;
      inhibitory control. In this context, the investigators have focused on an attention-enhancing&#xD;
      form of NFB based on the EEG alpha rhythm, known to influence sensory detection and&#xD;
      attention. In light of recent evidence showing that both attention and impulsivity can be&#xD;
      modified with a single-session of alpha-NFB, the objective is to determine whether these&#xD;
      effects stabilize in the long-term, after multiple, daily sessions of training at home.&#xD;
&#xD;
      A short- (single-session) and a long-term (multi-session) experimental design will be used to&#xD;
      collect EEG, behavioral, and clinical data pre-to-post NFB. The single-blind study will&#xD;
      recruit 48 adult ADHD participants randomly assigned to either NEUROFEEDBACK or CONTROL&#xD;
      groups. Each participant will undergo individual at home sessions of 45-minute video-replay&#xD;
      of popular television (TV) series while recording their 1-channel EEG (30 sessions, 5&#xD;
      sessions/week, 6 weeks total). In the NEUROFEEDBACK group, self-regulation of alpha rhythm&#xD;
      will be reflected in the dynamically varying opacity of the video-replay window, i.e. the&#xD;
      window would turn lighter/darker and reveal/obscure video content during episodes of low/high&#xD;
      alpha amplitude, respectively. In the CONTROL group, the recording will be passive without&#xD;
      real-time EEG neurofeedback (i.e. constant brightness and volume). Before and after at home&#xD;
      training, each participant will have two visits in the lab: (1) complete clinical and&#xD;
      neuropsychological evaluation and (2) EEG session including resting state and task-related&#xD;
      EEG before and after a short NFB intervention (30 minutes). For the CONTROL group&#xD;
      participants, the latter will be replaced by a sham intervention utilizing non-contingent&#xD;
      feedback.&#xD;
&#xD;
      Given that stronger alpha rhythmicity is associated with increases in inhibitory/excitatory&#xD;
      balance, it is expected that alpha-NFB (i) will homeostatically normalize alpha rhythm power&#xD;
      and (ii) the degree of normalization will be a dimensional predictor of individual&#xD;
      improvement in behavioral and clinical measures of executive function, impulsivity and&#xD;
      inattention. These results should lay the foundation for building neurocognitive treatments,&#xD;
      by harnessing neuroplasticity mechanisms intrinsic to the brain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 2, 2020</start_date>
  <completion_date type="Anticipated">April 2023</completion_date>
  <primary_completion_date type="Anticipated">April 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in assessor-evaluated clinical ADHD status</measure>
    <time_frame>Change between day 10 pre-intervention and day 10 post-intervention</time_frame>
    <description>Change in adult ADHD Child Evaluation (ACE+) scoring (min = 0, max = 36, higher score = worse outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in self-reported clinical ADHD status</measure>
    <time_frame>Change between day 10 pre-intervention and day 10 post-intervention</time_frame>
    <description>Change in adult ADHD Self-Report Scale (ASRS) scoring (min = 0, max = 72, higher score = worse outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Alpha Spectral Power</measure>
    <time_frame>Change between day 2 pre-intervention and day 2 post-intervention</time_frame>
    <description>Absolute and relative spectral alpha power in the 8-12 Hz frequency range at rest (microvolts)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in reaction time at the Continuous Performance Task (CPT)</measure>
    <time_frame>Change between day 2 pre-intervention and day 2 post-intervention</time_frame>
    <description>Reaction time and reaction time variability (milliseconds)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in error rates at the CPT</measure>
    <time_frame>Change between day 2 pre-intervention and day 2 post-intervention</time_frame>
    <description>Number of omission and commission errors</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Attention Deficit Disorder With Hyperactivity</condition>
  <arm_group>
    <arm_group_label>NEUROFEEDBACK</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants undergo individual at home sessions of 45-minute video-replay of popular TV series while recording their 1-channel EEG using a portable system. Self-regulation of alpha rhythm is reflected in the dynamically varying opacity of the video replay window, i.e. the window would turn lighter/darker and reveal/obscure video content during episodes of low/high alpha amplitude, respectively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CONTROL</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants undergo individual at home sessions of 45-minute video-replay of popular TV series while recording their 1-channel EEG using a portable system. The recording is passive without real-time EEG neurofeedback (i.e. constant brightness and volume).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NEUROFEEDBACK</intervention_name>
    <description>EEG recording during alpha-related TV viewing</description>
    <arm_group_label>NEUROFEEDBACK</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CONTROL</intervention_name>
    <description>EEG recording during passive TV viewing</description>
    <arm_group_label>CONTROL</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of ADHD&#xD;
&#xD;
          -  Currently stabilized (euthymic)&#xD;
&#xD;
          -  General good health&#xD;
&#xD;
          -  Normal or corrected-to normal visual acuity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mood Disorders&#xD;
&#xD;
          -  PTSD&#xD;
&#xD;
          -  Borderline Personality Disorder&#xD;
&#xD;
          -  Substance Use Disorder&#xD;
&#xD;
          -  Structural Brain Abnormalities&#xD;
&#xD;
          -  Cerebrovascular Disease&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Stroke&#xD;
&#xD;
          -  Head Trauma&#xD;
&#xD;
          -  Cardiovascular Disease&#xD;
&#xD;
          -  Renal Failure&#xD;
&#xD;
          -  Hepatic Dysfunction&#xD;
&#xD;
          -  Impaired visual acuity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexandre Dayer, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Geneva &amp; University Hospitals of Geneva</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nader Perroud, MD</last_name>
    <phone>+41 22 305 45 11</phone>
    <email>nader.perroud@hcuge.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marie Pierre Deiber, PhD</last_name>
    <phone>+41 22 305 53 80</phone>
    <email>marie-pierre.deiber@hcuge.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospitals of Geneva</name>
      <address>
        <city>Geneva</city>
        <zip>1201</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nader Perroud, MD</last_name>
      <phone>+41 22 305 45 11</phone>
      <email>nader.perroud@hcuge.ch</email>
    </contact>
    <contact_backup>
      <last_name>Marie Pierre Deiber, PhD</last_name>
      <phone>+41 22 305 53 80</phone>
      <email>marie-pierre.deiber@hcuge.ch</email>
    </contact_backup>
    <investigator>
      <last_name>Tomas Ros, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Arns M, de Ridder S, Strehl U, Breteler M, Coenen A. Efficacy of neurofeedback treatment in ADHD: the effects on inattention, impulsivity and hyperactivity: a meta-analysis. Clin EEG Neurosci. 2009 Jul;40(3):180-9. doi: 10.1177/155005940904000311.</citation>
    <PMID>19715181</PMID>
  </reference>
  <reference>
    <citation>Ergenoglu T, Demiralp T, Bayraktaroglu Z, Ergen M, Beydagi H, Uresin Y. Alpha rhythm of the EEG modulates visual detection performance in humans. Brain Res Cogn Brain Res. 2004 Aug;20(3):376-83. doi: 10.1016/j.cogbrainres.2004.03.009.</citation>
    <PMID>15268915</PMID>
  </reference>
  <reference>
    <citation>Macdonald JS, Mathan S, Yeung N. Trial-by-Trial Variations in Subjective Attentional State are Reflected in Ongoing Prestimulus EEG Alpha Oscillations. Front Psychol. 2011 May 10;2:82. doi: 10.3389/fpsyg.2011.00082. eCollection 2011.</citation>
    <PMID>21687452</PMID>
  </reference>
  <reference>
    <citation>Micoulaud-Franchi JA, Geoffroy PA, Fond G, Lopez R, Bioulac S, Philip P. EEG neurofeedback treatments in children with ADHD: an updated meta-analysis of randomized controlled trials. Front Hum Neurosci. 2014 Nov 13;8:906. doi: 10.3389/fnhum.2014.00906. eCollection 2014.</citation>
    <PMID>25431555</PMID>
  </reference>
  <reference>
    <citation>Heidbreder R. ADHD symptomatology is best conceptualized as a spectrum: a dimensional versus unitary approach to diagnosis. Atten Defic Hyperact Disord. 2015 Dec;7(4):249-69. doi: 10.1007/s12402-015-0171-4. Epub 2015 May 10.</citation>
    <PMID>25957598</PMID>
  </reference>
  <results_reference>
    <citation>Deiber MP, Hasler R, Colin J, Dayer A, Aubry JM, Baggio S, Perroud N, Ros T. Linking alpha oscillations, attention and inhibitory control in adult ADHD with EEG neurofeedback. Neuroimage Clin. 2020;25:102145. doi: 10.1016/j.nicl.2019.102145. Epub 2019 Dec 24.</citation>
    <PMID>31911342</PMID>
  </results_reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>May 12, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 17, 2022</last_update_submitted>
  <last_update_submitted_qc>May 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
    <investigator_full_name>Nader Perroud</investigator_full_name>
    <investigator_title>MD, Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Electroencephalography</keyword>
  <keyword>Alpha Rhythm</keyword>
  <keyword>Attention</keyword>
  <keyword>Impulsive Behavior</keyword>
  <keyword>Neurofeedback</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperkinesis</mesh_term>
    <mesh_term>Attention Deficit Disorder with Hyperactivity</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/NCT04408521
org study id: 2017-01029
secondary id: SNCTP000002260
nct id: NCT04408521
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Mounting evidence suggests that closed-loop brain-training, commonly known as neurofeedback
      (NFB), may represent a new therapeutic opportunity for patients with Attentional
      Deficit/Hyperactivity Disorder (ADHD), which manifests as difficulties with attention and
      inhibitory control. In this context, the investigators have focused on an attention-enhancing
      form of NFB based on the EEG alpha rhythm, known to influence sensory detection and
      attention. In light of recent evidence showing that both attention and impulsivity can be
      modified with a single-session of alpha-NFB, the objective is to determine whether these
      effects stabilize in the long-term, after multiple, daily sessions of training at home.

      A short- (single-session) and a long-term (multi-session) experimental design will be used to
      collect EEG, behavioral, and clinical data pre-to-post NFB. The single-blind study will
      recruit 48 adult ADHD participants randomly assigned to either NEUROFEEDBACK or CONTROL
      groups. Each participant will undergo individual at home sessions of 45-minute video-replay
      of popular television (TV) series while recording their 1-channel EEG (30 sessions, 5
      sessions/week, 6 weeks total). In the NEUROFEEDBACK group, self-regulation of alpha rhythm
      will be reflected in the dynamically varying opacity of the video-replay window, i.e. the
      window would turn lighter/darker and reveal/obscure video content during episodes of low/high
      alpha amplitude, respectively. In the CONTROL group, the recording will be passive without
      real-time EEG neurofeedback (i.e. constant brightness and volume). Before and after at home
      training, each participant will have two visits in the lab: (1) complete clinical and
      neuropsychological evaluation and (2) EEG session including resting state and task-related
      EEG before and after a short NFB intervention (30 minutes). For the CONTROL group
      participants, the latter will be replaced by a sham intervention utilizing non-contingent
      feedback.

      Given that stronger alpha rhythmicity is associated with increases in inhibitory/excitatory
      balance, it is expected that alpha-NFB (i) will homeostatically normalize alpha rhythm power
      and (ii) the degree of normalization will be a dimensional predictor of individual
      improvement in behavioral and clinical measures of executive function, impulsivity and
      inattention. These results should lay the foundation for building neurocognitive treatments,
      by harnessing neuroplasticity mechanisms intrinsic to the brain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change in assessor-evaluated clinical ADHD status
time frame: Change between day 10 pre-intervention and day 10 post-intervention
description: Change in adult ADHD Child Evaluation (ACE+) scoring (min = 0, max = 36, higher score = worse outcome)
measure: Change in self-reported clinical ADHD status
time frame: Change between day 10 pre-intervention and day 10 post-intervention
description: Change in adult ADHD Self-Report Scale (ASRS) scoring (min = 0, max = 72, higher score = worse outcome)
measure: Change in Alpha Spectral Power
time frame: Change between day 2 pre-intervention and day 2 post-intervention
description: Absolute and relative spectral alpha power in the 8-12 Hz frequency range at rest (microvolts)
measure: Change in reaction time at the Continuous Performance Task (CPT)
time frame: Change between day 2 pre-intervention and day 2 post-intervention
description: Reaction time and reaction time variability (milliseconds)
measure: Change in error rates at the CPT
time frame: Change between day 2 pre-intervention and day 2 post-intervention
description: Number of omission and commission errors
arm group label: NEUROFEEDBACK
arm group type: Experimental
description: Participants undergo individual at home sessions of 45-minute video-replay of popular TV series while recording their 1-channel EEG using a portable system. Self-regulation of alpha rhythm is reflected in the dynamically varying opacity of the video replay window, i.e. the window would turn lighter/darker and reveal/obscure video content during episodes of low/high alpha amplitude, respectively.
arm group label: CONTROL
arm group type: Placebo Comparator
description: Participants undergo individual at home sessions of 45-minute video-replay of popular TV series while recording their 1-channel EEG using a portable system. The recording is passive without real-time EEG neurofeedback (i.e. constant brightness and volume).
intervention type: Other
intervention name: NEUROFEEDBACK
description: EEG recording during alpha-related TV viewing
arm group label: NEUROFEEDBACK
intervention type: Other
intervention name: CONTROL
description: EEG recording during passive TV viewing
arm group label: CONTROL
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Alexandre Dayer, MD, PhD
role: Study Director
affiliation: University of Geneva & University Hospitals of Geneva
last name: Nader Perroud, MD
phone: +41 22 305 45 11
email: nader.perroud@hcuge.ch
last name: Marie Pierre Deiber, PhD
phone: +41 22 305 53 80
email: marie-pierre.deiber@hcuge.ch
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Switzerland
citation: Arns M, de Ridder S, Strehl U, Breteler M, Coenen A. Efficacy of neurofeedback treatment in ADHD: the effects on inattention, impulsivity and hyperactivity: a meta-analysis. Clin EEG Neurosci. 2009 Jul;40(3):180-9. doi: 10.1177/155005940904000311.
PMID: 19715181
citation: Ergenoglu T, Demiralp T, Bayraktaroglu Z, Ergen M, Beydagi H, Uresin Y. Alpha rhythm of the EEG modulates visual detection performance in humans. Brain Res Cogn Brain Res. 2004 Aug;20(3):376-83. doi: 10.1016/j.cogbrainres.2004.03.009.
PMID: 15268915
citation: Macdonald JS, Mathan S, Yeung N. Trial-by-Trial Variations in Subjective Attentional State are Reflected in Ongoing Prestimulus EEG Alpha Oscillations. Front Psychol. 2011 May 10;2:82. doi: 10.3389/fpsyg.2011.00082. eCollection 2011.
PMID: 21687452
citation: Micoulaud-Franchi JA, Geoffroy PA, Fond G, Lopez R, Bioulac S, Philip P. EEG neurofeedback treatments in children with ADHD: an updated meta-analysis of randomized controlled trials. Front Hum Neurosci. 2014 Nov 13;8:906. doi: 10.3389/fnhum.2014.00906. eCollection 2014.
PMID: 25431555
citation: Heidbreder R. ADHD symptomatology is best conceptualized as a spectrum: a dimensional versus unitary approach to diagnosis. Atten Defic Hyperact Disord. 2015 Dec;7(4):249-69. doi: 10.1007/s12402-015-0171-4. Epub 2015 May 10.
PMID: 25957598
citation: Deiber MP, Hasler R, Colin J, Dayer A, Aubry JM, Baggio S, Perroud N, Ros T. Linking alpha oscillations, attention and inhibitory control in adult ADHD with EEG neurofeedback. Neuroimage Clin. 2020;25:102145. doi: 10.1016/j.nicl.2019.102145. Epub 2019 Dec 24.
PMID: 31911342
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Geneva
investigator full name: Nader Perroud
investigator title: MD, Associate Professor
mesh term: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity
sharing ipd: No