<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/NCT04420767</url>
  </required_header>
  <id_info>
    <org_study_id>IRB#15-001929</org_study_id>
    <nct_id>NCT04420767</nct_id>
  </id_info>
  <brief_title>The Effect of Brain Stimulation (tDCS) in Food Cravings Control in Overweight/Obese Women</brief_title>
  <official_title>The Effect of Brain Neuromodulation on Food Cravings, Cognitive Control and Food Addiction Scales in Overweight/Obese Women Using tDCS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a randomized clinical trial to test the effect of a type of non-invasive brain&#xD;
      stimulation on the response to a behavioral intervention designed to enhance cognitive&#xD;
      control over food cravings in obese and overweight women. The brain stimulation is called&#xD;
      transcranial Direct Current Stimulation (tDCS). All eligible participants will engage in a&#xD;
      behavioral intervention known to enhance control over food cravings and will be randomly&#xD;
      assigned to receive either tDCS or sham stimulation to the prefrontal cortex of the brain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized clinical trial to test the effect of a type of non-invasive brain&#xD;
      stimulation on the response to a behavioral intervention designed to enhance cognitive&#xD;
      control over food cravings in obese and overweight women. The brain stimulation is called&#xD;
      transcranial Direct Current Stimulation (tDCS) which is a form of stimulation that delivers a&#xD;
      low amplitude electrical current to the brain via the scalp (i.e. trans-cranial) to modify&#xD;
      brain activity.&#xD;
&#xD;
      All eligible participants will engage in a behavioral intervention (Go-No Go task), known to&#xD;
      enhance control over food cravings, and will be randomly assigned to receive either tDCS or&#xD;
      sham stimulation to the right prefrontal cortex of the brain during 8 20-min daily sessions.&#xD;
&#xD;
      Primary outcome: score changes in eating behaviors scales (YFAS and TFEQ), scales will be&#xD;
      applied at baseline and at the end of the 8 brain stimulation sessions.&#xD;
&#xD;
      Secondary outcomes: changes in diet, brain function (brain MRI/MRS) Other outcomes: food&#xD;
      cravings scales and impulse control scales and cognitive function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 4, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2021</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Yale Food Addiction Scale scores</measure>
    <time_frame>Scores measured at baseline and at up-to 2 weeks after the intervention</time_frame>
    <description>Yale Food Addiction Scale (YFAS26) that is a 25-item measure developed to measure food addiction. Score range: 0 to 7. Higher scores in the scale mean more symptoms resembling food addiction (worse).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Three-Factor Eating Questionnaire scores</measure>
    <time_frame>Scores measured at baseline and at up-to 2 weeks after the intervention</time_frame>
    <description>Three-Factor Eating Questionnaire is a validated scale that is designed to measure 3 dimensions of human eating behavior: cognitive restraint of eating (Factor I), disinhibition (Factor II), and hunger (Factor III). The minimum score for factors I-II-III is therefore 0-0-0, and maximum possible score is 20-16-15. Higher scores in the respective scales are indicative of greater cognitive restraint (better), uncontrolled (worse), or emotional eating (worse).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in brain neural activity by functional Magnetic Resonance Imaging ( fMRI)</measure>
    <time_frame>Brain function at baseline and up-to 2 weeks after the intervention</time_frame>
    <description>Significant change in brain activity of the prefrontal cortex (area involved in the inhibitory control of food intake) measured by modification of BOLD (Blood-Oxygen-Level-Dependent) signal in fMRI evoked responses to visual food-cues</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Brain metabolites concentrations by Magnetic Resonance Spectroscopy (MRS)</measure>
    <time_frame>Brain MRS at baseline and up-to 2 weeks after the intervention</time_frame>
    <description>Significant change in brain metabolites concentration at the prefrontal cortex (area involved in the inhibitory control of food intake) measured with Magnetic Resonance spectroscopy</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Diet (3-day food intake record)</measure>
    <time_frame>Values measured at baseline and at up-to 2 weeks after the intervention</time_frame>
    <description>3-day food intake record: individuals will record everything they eat and drink for 3 days. To assess calorie intake and macro nutrients</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Yale Food Addiction Scale scores at 3-months post-intervention</measure>
    <time_frame>At 3-months after intervention</time_frame>
    <description>Yale Food Addiction Scale (YFAS26) that is a 25-item measure developed to measure food addiction. Score range: 0 to 7. Higher scores in the scale mean more symptoms resembling food addiction (worse).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Three-Factor Eating Questionnaire scores at 3-months post-intervention</measure>
    <time_frame>At 3-months after intervention</time_frame>
    <description>Three-Factor Eating Questionnaire is a validated scale that is designed to measure 3 dimensions of human eating behavior: cognitive restraint of eating (Factor I), disinhibition (Factor II), and hunger (Factor III). The minimum score for factors I-II-III is therefore 0-0-0, and maximum possible score is 20-16-15. Higher scores in the respective scales are indicative of greater cognitive restraint (better), uncontrolled (worse), or emotional eating (worse).</description>
  </other_outcome>
  <other_outcome>
    <measure>Cognitive function assessment</measure>
    <time_frame>Measured at baseline and up-to 2 weeks after the intervention</time_frame>
    <description>Multiple Abilities Self-Report Questionnaire (MASQ), a self-report measure comprising items from five cognitive domains; language, visuo-perceptual, verbal memory, visual memory, and attention. The maximum score for the whole scale is 190 points. Higher scores correlate with better function.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>tDCS and Go-No Go task</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Certain randomly assigned participants will receive tDCS to the DLPFC for 8 daily 20-minute sessions, with a TDCS amplitude of 2 mAmps.&#xD;
During the tDCS session, individuals will perform a 10-min computerized Go-No Go task</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham brain stimulation and Go-No Go task</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Certain randomly assigned participants will receive Sham Stimulation to the DLPFC for 8 daily 20-min sessions. The Sham stimulation is an inactive form of stimulation.&#xD;
During the sham brain stimulation session, individuals will perform a 10-min computerized Go-No Go task</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tDCS</intervention_name>
    <description>Individuals undergo 20min daily sessions receiving actual tDCS to the brain (to the right DLPFC: dorsolateral prefrontal cortex)</description>
    <arm_group_label>tDCS and Go-No Go task</arm_group_label>
    <other_name>Real brain stimulation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham brain stimulation</intervention_name>
    <description>Individuals undergo 20min daily sessions receiving sham stimulation to the brain (to the right DLPFC: dorsolateral prefrontal cortex)</description>
    <arm_group_label>Sham brain stimulation and Go-No Go task</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Go-No GO task</intervention_name>
    <description>During the brain stimulation sessions, all individuals will be asked to perform a 10 min-computerized task related to inhibitory control (Go-No Go)</description>
    <arm_group_label>Sham brain stimulation and Go-No Go task</arm_group_label>
    <arm_group_label>tDCS and Go-No Go task</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        BMI between 28 and 40 kg/m2 high scores in the Yale-Food Addiction-Scale right-handed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of anorexia nervosa or bulimia or binge eating disorder&#xD;
&#xD;
          -  Any contraindication to undergo MRI&#xD;
&#xD;
          -  Use of psychotropic medications and/or opiate pain medications.&#xD;
&#xD;
          -  Current or past alcohol or drug abuse problem or smoking&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Current use of weight loss medication or currently participating in a weight loss&#xD;
             program.&#xD;
&#xD;
          -  History of seizures, epilepsy or factors/medications associated with lowered seizure&#xD;
             threshold.&#xD;
&#xD;
          -  History of brain disease or major neurological disorder or mental disorder&#xD;
&#xD;
          -  History of brain surgery or history of loss of consciousness &gt;15 min&#xD;
&#xD;
          -  History of major gastrointestinal surgery including weight loss surgery&#xD;
&#xD;
          -  History of endocrine imbalances including diabetes, thyroid disease, Cushing's&#xD;
             disease, metabolic syndrome and polycystic ovary.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claudia P Sanmiguel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>April 21, 2017</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Claudia P. Sanmiguel, MD</investigator_full_name>
    <investigator_title>Health Sciences Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>food cravings</keyword>
  <keyword>neuromodulation</keyword>
  <keyword>brain</keyword>
  <keyword>cognitive control</keyword>
  <keyword>tDCS</keyword>
  <keyword>prefrontal cortex</keyword>
  <keyword>MRI</keyword>
  <keyword>food addiction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Food Addiction</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>June 24, 2023</submitted>
    <returned>July 14, 2023</returned>
  </pending_results>
  <!-- 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/NCT04420767
org study id: IRB#15-001929
nct id: NCT04420767
lead sponsor: 
has dmc: No
This study is a randomized clinical trial to test the effect of a type of non-invasive brain
      stimulation on the response to a behavioral intervention designed to enhance cognitive
      control over food cravings in obese and overweight women. The brain stimulation is called
      transcranial Direct Current Stimulation (tDCS). All eligible participants will engage in a
      behavioral intervention known to enhance control over food cravings and will be randomly
      assigned to receive either tDCS or sham stimulation to the prefrontal cortex of the brain.
This study is a randomized clinical trial to test the effect of a type of non-invasive brain
      stimulation on the response to a behavioral intervention designed to enhance cognitive
      control over food cravings in obese and overweight women. The brain stimulation is called
      transcranial Direct Current Stimulation (tDCS) which is a form of stimulation that delivers a
      low amplitude electrical current to the brain via the scalp (i.e. trans-cranial) to modify
      brain activity.

      All eligible participants will engage in a behavioral intervention (Go-No Go task), known to
      enhance control over food cravings, and will be randomly assigned to receive either tDCS or
      sham stimulation to the right prefrontal cortex of the brain during 8 20-min daily sessions.

      Primary outcome: score changes in eating behaviors scales (YFAS and TFEQ), scales will be
      applied at baseline and at the end of the 8 brain stimulation sessions.

      Secondary outcomes: changes in diet, brain function (brain MRI/MRS) Other outcomes: food
      cravings scales and impulse control scales and cognitive function.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Yale Food Addiction Scale scores
time frame: Scores measured at baseline and at up-to 2 weeks after the intervention
description: Yale Food Addiction Scale (YFAS26) that is a 25-item measure developed to measure food addiction. Score range: 0 to 7. Higher scores in the scale mean more symptoms resembling food addiction (worse).
measure: Change in Three-Factor Eating Questionnaire scores
time frame: Scores measured at baseline and at up-to 2 weeks after the intervention
description: Three-Factor Eating Questionnaire is a validated scale that is designed to measure 3 dimensions of human eating behavior: cognitive restraint of eating (Factor I), disinhibition (Factor II), and hunger (Factor III). The minimum score for factors I-II-III is therefore 0-0-0, and maximum possible score is 20-16-15. Higher scores in the respective scales are indicative of greater cognitive restraint (better), uncontrolled (worse), or emotional eating (worse).
measure: Change in brain neural activity by functional Magnetic Resonance Imaging ( fMRI)
time frame: Brain function at baseline and up-to 2 weeks after the intervention
description: Significant change in brain activity of the prefrontal cortex (area involved in the inhibitory control of food intake) measured by modification of BOLD (Blood-Oxygen-Level-Dependent) signal in fMRI evoked responses to visual food-cues
measure: Change in Brain metabolites concentrations by Magnetic Resonance Spectroscopy (MRS)
time frame: Brain MRS at baseline and up-to 2 weeks after the intervention
description: Significant change in brain metabolites concentration at the prefrontal cortex (area involved in the inhibitory control of food intake) measured with Magnetic Resonance spectroscopy
measure: Diet (3-day food intake record)
time frame: Values measured at baseline and at up-to 2 weeks after the intervention
description: 3-day food intake record: individuals will record everything they eat and drink for 3 days. To assess calorie intake and macro nutrients
measure: Change in Yale Food Addiction Scale scores at 3-months post-intervention
time frame: At 3-months after intervention
description: Yale Food Addiction Scale (YFAS26) that is a 25-item measure developed to measure food addiction. Score range: 0 to 7. Higher scores in the scale mean more symptoms resembling food addiction (worse).
measure: Change in Three-Factor Eating Questionnaire scores at 3-months post-intervention
time frame: At 3-months after intervention
description: Three-Factor Eating Questionnaire is a validated scale that is designed to measure 3 dimensions of human eating behavior: cognitive restraint of eating (Factor I), disinhibition (Factor II), and hunger (Factor III). The minimum score for factors I-II-III is therefore 0-0-0, and maximum possible score is 20-16-15. Higher scores in the respective scales are indicative of greater cognitive restraint (better), uncontrolled (worse), or emotional eating (worse).
measure: Cognitive function assessment
time frame: Measured at baseline and up-to 2 weeks after the intervention
description: Multiple Abilities Self-Report Questionnaire (MASQ), a self-report measure comprising items from five cognitive domains; language, visuo-perceptual, verbal memory, visual memory, and attention. The maximum score for the whole scale is 190 points. Higher scores correlate with better function.
arm group label: tDCS and Go-No Go task
arm group type: Experimental
description: Certain randomly assigned participants will receive tDCS to the DLPFC for 8 daily 20-minute sessions, with a TDCS amplitude of 2 mAmps.
During the tDCS session, individuals will perform a 10-min computerized Go-No Go task
arm group label: Sham brain stimulation and Go-No Go task
arm group type: Sham Comparator
description: Certain randomly assigned participants will receive Sham Stimulation to the DLPFC for 8 daily 20-min sessions. The Sham stimulation is an inactive form of stimulation.
During the sham brain stimulation session, individuals will perform a 10-min computerized Go-No Go task
intervention type: Device
intervention name: tDCS
description: Individuals undergo 20min daily sessions receiving actual tDCS to the brain (to the right DLPFC: dorsolateral prefrontal cortex)
arm group label: tDCS and Go-No Go task
other name: Real brain stimulation
intervention type: Device
intervention name: Sham brain stimulation
description: Individuals undergo 20min daily sessions receiving sham stimulation to the brain (to the right DLPFC: dorsolateral prefrontal cortex)
arm group label: Sham brain stimulation and Go-No Go task
intervention type: Behavioral
intervention name: Go-No GO task
description: During the brain stimulation sessions, all individuals will be asked to perform a 10 min-computerized task related to inhibitory control (Go-No Go)
arm group label: Sham brain stimulation and Go-No Go task
arm group label: tDCS and Go-No Go task
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Claudia P Sanmiguel, MD
role: Principal Investigator
affiliation: University of California, Los Angeles
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Claudia P. Sanmiguel, MD
investigator title: Health Sciences Assistant Professor
mesh term: Overweight
mesh term: Food Addiction
submitted: June 24, 2023
returned: July 14, 2023