[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05225233":3,"trial-entities:NCT05225233":118,"trial-summary:NCT05225233":121},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":42,"secondary_outcomes":51,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":64,"eligibility_criteria":65,"std_ages":85,"locations":88,"central_contacts":107,"overall_officials":114,"references":116,"see_also_links":117},"NCT05225233","NURA-009-21S","tDCS With Cognitive Training to Reduce Impulsivity and Weight in Veterans With Obesity","Transcranial Direct Current Stimulation (tDCS) With Cognitive Training to Reduce Impulsivity and Weight in Veterans With Obesity: A Clinical Trial","RECRUITING","2026-12-31","2026-03","2026-04-07","2022-11-23","VA Office of Research and Development","FED",true,"The purpose of this study is to investigate if transcranial direct current stimulation (tDCS) can increase the effectiveness of cognitive training to reduce impulsivity in individuals with obesity, and to evaluate weight change with these individuals. The long-term goal of this research is to develop new treatment approaches for individuals with obesity.","Two-hundred forty individuals will be screened with the goal of consenting and enrolling up to 124 patients and 88 patients completing the study. Participants completing the study will concurrently complete a structured weight loss program. The investigators' study protocol will consist of 13 study visits including four testing days, one before (V1), one on the day of the tenth session of tDCS (V11), another test visit (V12) 6 weeks later, and a final test visit approximately 4 months after beginning stimulation (V13).",[19],"Obesity",[21,22],"transcranial direct current stimulation","neuromodulation","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},124,"ESTIMATED",[31,37],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DEVICE","Sham Transcranial Direct Current Stimulation (tDCS)","Cognitive training concurrent with sham tDCS (30 seconds ramp up\u002Framp down at the beginning of the session)",[36],"Sham tDCS with Cognitive Training",{"type":32,"name":38,"description":39,"armGroupLabels":40},"Active Transcranial Direct Current Stimulation (tDCS)","Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.",[41],"Active tDCS with Cognitive Training",[43,47],{"measure":44,"description":45,"timeFrame":46},"Change in task impulsivity as measured by the NIH Flanker","Differences in the magnitude of change in NIH Flanker Reaction Time (RT) (ms) between active and sham groups from baseline to follow up sessions.","Change between baseline and Visit 11, Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months)",{"measure":48,"description":49,"timeFrame":50},"Change in weight","Differences in the magnitude of change in weights (kg) between active and sham tDCS (active from baseline to follow up sessions.","Change between baseline and Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months)",[52,55,58],{"measure":53,"description":54,"timeFrame":46},"Change in reported impulsivity as measured by the Barratt Impulsiveness Scale (BIS)","Differences in the magnitude of change in BIS scores (Likert scale points) will be compared between active and sham tDCS groups from baseline to follow up sessions.",{"measure":56,"description":57,"timeFrame":46},"Change in reported impulsivity as measured by the UPPS-P Impulsive Behavior Scale (UPPS-P)","Differences in the magnitude of change in UPPS-P scores (Likert scale points) will be compared between active and sham tDCS groups from baseline to follow up sessions.",{"measure":59,"description":60,"timeFrame":46},"Change in reported binge eating as measured by the Binge Eating Scale (BES)","Differences in the magnitude of change in BES scores (Likert scale points) will be compared between active and sham tDCS groups from baseline to follow up sessions.","ALL","18 Years","80 Years",false,{"inclusion":66,"exclusion":72,"raw_text":84},[67,68,69,70,71],"Veteran enrolled in a MOVE! Weight Management Program (group or individual) at the Minneapolis VA Health Care System","Obese (BMI\\>30 or BMI\\>27 plus at least one weight-related comorbidity)","Adults, ages 18 years or older (up to age 80)","Able to understand English, self-consent and follow study-related procedures","Willing to use a reliable form of birth control if they are of females of child-bearing potential",[73,74,75,76,77,78,79,80,81,82,83],"History of any of the following: seizures, severe or moderate head injury, head surgery, significant neurological disorder (significance based on Principal Investigator's judgment)","Frequent severe headaches","History of scalp conditions such as eczema or seborrheic dermatitis","Metal in head (other than in mouth) including shrapnel\u002Fsurgical clips\u002Fwelding fragments","Implanted medical devices (including pumps and cardiac pacemakers)","Pregnancy","Acute substance dependence or withdrawal that would affect ability to complete cognitive training","Moderately severe to severe depression (as identified on PHQ-9 scale during baseline screening)","Other psychological or medical disorders requiring inpatient treatment (as identified during chart review)","Presence of a known metabolic or hormonal disorder (such as Cushing's, untreated thyroid dysfunction, or uncontrolled diabetes mellitus defined as a hemoglobin A1c \\> 8.0), or significant edema\u002Fvolume overload - all of which would affect weight","Uncontrolled hypothyroidism that would affect weight","Inclusion Criteria:\n\n* Veteran enrolled in a MOVE! Weight Management Program (group or individual) at the Minneapolis VA Health Care System\n* Obese (BMI\\>30 or BMI\\>27 plus at least one weight-related comorbidity)\n* Adults, ages 18 years or older (up to age 80)\n* Able to understand English, self-consent and follow study-related procedures\n* Willing to use a reliable form of birth control if they are of females of child-bearing potential\n\nExclusion Criteria:\n\n* History of any of the following: seizures, severe or moderate head injury, head surgery, significant neurological disorder (significance based on Principal Investigator's judgment)\n* Frequent severe headaches\n* History of scalp conditions such as eczema or seborrheic dermatitis\n* Metal in head (other than in mouth) including shrapnel\u002Fsurgical clips\u002Fwelding fragments\n* Implanted medical devices (including pumps and cardiac pacemakers)\n* Pregnancy\n* Acute substance dependence or withdrawal that would affect ability to complete cognitive training\n* Moderately severe to severe depression (as identified on PHQ-9 scale during baseline screening)\n* Other psychological or medical disorders requiring inpatient treatment (as identified during chart review)\n* Presence of a known metabolic or hormonal disorder (such as Cushing's, untreated thyroid dysfunction, or uncontrolled diabetes mellitus defined as a hemoglobin A1c \\> 8.0), or significant edema\u002Fvolume overload - all of which would affect weight\n* Uncontrolled hypothyroidism that would affect weight",[86,87],"ADULT","OLDER_ADULT",[89],{"facility":90,"status":8,"city":91,"state":92,"zip":93,"country":94,"contacts":95,"geoPoint":104},"Minneapolis VA Health Care System, Minneapolis, MN","Minneapolis","Minnesota","55417-2309","United States",[96,102],{"name":97,"role":98,"phone":99,"phoneExt":100,"email":101},"Shalamar D Sibley, MD","CONTACT","612-725-2000","4424","Shalamar.Sibley@va.gov",{"name":97,"role":103},"PRINCIPAL_INVESTIGATOR",{"lat":105,"lon":106},44.97997,-93.26384,[108,110],{"name":97,"role":98,"phone":109,"phoneExt":100,"email":101},"(612) 725-2000",{"name":111,"role":98,"phone":112,"email":113},"Lisa E Keacher, BS","(612) 467-5203","lisa.keacher@va.gov",[115],{"name":97,"affiliation":90,"role":103},[],[],{"nct_id":4,"conditions":119,"biomarkers":120},[19],[],{"nct_id":4,"found":15,"summary":122,"prompt_version":132},{"design":123,"status":124,"heading":125,"summary":126,"follow_up":127,"word_count":128,"commitments":129,"compensation":130,"drugs_mentioned":131},"This interventional study plans to enroll up to 124 participants, comparing active transcranial direct current stimulation (tDCS) with sham tDCS during cognitive training.","completed","tDCS with Cognitive Training for Obesity in Veterans","This study is looking at whether transcranial direct current stimulation (tDCS) can help veterans with obesity reduce impulsivity and lose weight. tDCS is a non-invasive treatment that uses a mild electrical current to stimulate specific areas of the brain. You would participate in cognitive training sessions while receiving either active tDCS or a sham (inactive) tDCS. To join, you need to be a veteran aged 18-80, enrolled in a MOVE! Weight Management Program at the Minneapolis VA, and have obesity. The study aims to see if this combination can improve impulse control and lead to weight loss. The current status of this study is unclear, and it plans to enroll up to 124 participants.","Your weight and impulsivity will be measured approximately 2 months and 4 months after starting stimulation.",114,"You would have 13 study visits, including four testing days, over approximately four months after starting stimulation.","Not stated in the trial record.",[],"v2"]