Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309, United States
Location status: Recruiting
NCT Number: NCT05225233
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Minneapolis, Minnesota, 55417-2309, United States
Location status: Recruiting
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cognitive training concurrent with sham tDCS (30 seconds ramp up/ramp down at the beginning of the session)
Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.
Time frame: Change between baseline and Visit 11, Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months)
Differences in the magnitude of change in NIH Flanker Reaction Time (RT) (ms) between active and sham groups from baseline to follow up sessions.
Time frame: Change between baseline and Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months)
Differences in the magnitude of change in weights (kg) between active and sham tDCS (active from baseline to follow up sessions.
Time frame: Change between baseline and Visit 11, Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months)
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.
Time frame: Change between baseline and Visit 11, Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months)
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.
Time frame: Change between baseline and Visit 11, Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months)
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.
Contact information is provided by the study sponsor or research team.
VA Office of Research and Development
Fed
Transcranial Direct Current Stimulation (tDCS) With Cognitive Training to Reduce Impulsivity and Weight in Veterans With Obesity: A Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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