Study Summary
This trial will study whether electrical stimulation of the dorsolateral prefrontal cortex, which is important in determining the feeling of fullness after eating, affects how much food a person eats and weight loss over 4 weeks. It will also compare weight changes in people who attend weight loss counseling sessions and those who do not over this period of time.
Eligible Conditions
- Electrotherapy
- Eating Disorder
- Weight Loss
- Obesity
Treatment Effectiveness
Effectiveness Progress
Study Objectives
5 Primary · 17 Secondary · Reporting Duration: Baseline, 1 year
Baseline, 1 year
weight loss
Baseline, week 9
Correlation between food intake and responses to behavioral tests and neuropsychological performance tests
Effect of tDCS on food intake
Effect of tDCS on macronutrient preferences
Effect of tDCS on responses to behavioral tests and neuropsychological performance tests
food intake
macronutrient preferences
responses to Gormally Binge Eating Questionnaire
responses to MacArthur Scale of Subjective Social Status
responses to Perceived Stress Scale
responses to Three Factor Eating Questionnaire
Week 1
Correlation between food intake and appetitive hormone levels
Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, appetitive hormone levels measured in blood
responses to Go/No Go Task
responses to Iowa Gambling Task
Year 1
Correlation between weight change and appetitive hormone levels
Correlation between weight change and responses to behavioral tests and neuropsychological performance tests
Effect of tDCS on weight loss
Weeks 1 and 9
Effect of tDCS on appetitive hormone levels
Effect of tDCS on brain fMRI activation in the left DLPFC when shown food vs. nonfood visual cues
GLP-1
Ghrelin
Brain
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
7 Treatment Groups
2-Active
1 of 7
3-Active
1 of 7
Active
1 of 7
2-Sham
1 of 7
1-Sham
1 of 7
3-Sham
1 of 7
Sham
1 of 7
Active Control
Experimental Treatment
Non-Treatment Group
148 Total Participants · 7 Treatment Groups
Primary Treatment: Transcranial Direct Current Stimulation (TDCS) · Has Placebo Group · Phase 2
Active
Device
Experimental Group · 1 Intervention: Transcranial Direct Current Stimulation (TDCS) · Intervention Types: Device2-Active
Device
ActiveComparator Group · 1 Intervention: Transcranial Direct Current Stimulation (TDCS) · Intervention Types: Device2-Sham
Other
ShamComparator Group · 1 Intervention: Sham/no-stimulation · Intervention Types: Other3-Active
Device
ActiveComparator Group · 1 Intervention: Transcranial Direct Current Stimulation (TDCS) · Intervention Types: Device1-Sham
Device
ShamComparator Group · 1 Intervention: Transcranial Direct Current Stimulation (TDCS) · Intervention Types: Device3-Sham
Other
ShamComparator Group · 1 Intervention: Sham/no-stimulation · Intervention Types: OtherSham
Other
ShamComparator Group · 1 Intervention: Sham/no-stimulation · Intervention Types: OtherTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1 year
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,148 Previous Clinical Trials
4,074,631 Total Patients Enrolled
Marci E Gluck, Ph.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 Previous Clinical Trials
5,000 Total Patients Enrolled
Marci Gluck, Ph.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
2 Previous Clinical Trials
5,100 Total Patients Enrolled
Eligibility Criteria
Age 18 - 60 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Arizona | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| NIDDK, Phoenix | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
References
- Le, Duc Son NT, Nicola Pannacciulli, Kewei Chen, Arline D Salbe, James O Hill, Rena R Wing, Eric M Reiman, and Jonathan Krakoff. 2007. “Less Activation in the Left Dorsolateral Prefrontal Cortex in the Reanalysis of the Response to a Meal in Obese Than in Lean Women and Its Association with Successful Weight Loss”. The American Journal of Clinical Nutrition. Oxford University Press (OUP). doi:10.1093/ajcn/86.3.573.
- Heinitz, Sascha, Martin Reinhardt, Paolo Piaggi, Christopher M Weise, Enrique Diaz, Emma J Stinson, Colleen Venti, et al.. 2017. “Neuromodulation Directed at the Prefrontal Cortex of Subjects with Obesity Reduces Snack Food Intake and Hunger in a Randomized Trial”. The American Journal of Clinical Nutrition. Oxford University Press (OUP). doi:10.3945/ajcn.117.158089.
- Gluck, Marci E., Miguel Alonso-Alonso, Paolo Piaggi, Christopher M. Weise, Reiner Jumpertz-von Schwartzenberg, Martin Reinhardt, Eric M. Wassermann, Colleen A. Venti, Susanne B. Votruba, and Jonathan Krakoff. 2015. “Neuromodulation Targeted to the Prefrontal Cortex Induces Changes in Energy Intake and Weight Loss in Obesity”. Obesity. Wiley. doi:10.1002/oby.21313.
- Stinson EJ, Travis KT, Magerowski G, Alonso-Alonso M, Krakoff J, Gluck ME. Improved food Go/No-Go scores after transcranial direct current stimulation (tDCS) to prefrontal cortex in a randomized trial. Obesity (Silver Spring). 2022 Oct;30(10):2005-2013. doi: 10.1002/oby.23529. Epub 2022 Sep 2.
- Le DS, Pannacciulli N, Chen K, Salbe AD, Del Parigi A, Hill JO, Wing RR, Reiman EM, Krakoff J. Less activation in the left dorsolateral prefrontal cortex in the reanalysis of the response to a meal in obese than in lean women and its association with successful weight loss. Am J Clin Nutr. 2007 Sep;86(3):573-9. doi: 10.1093/ajcn/86.3.573. Erratum In: Am J Clin Nutr. 2008 Feb;87(2):463. Del Parigi, Angelo [added].
- 2009. "Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00739362.
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Conditions
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