Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00739362|
Recruitment Status : Recruiting
First Posted : August 21, 2008
Last Update Posted : April 1, 2021
This study will determine whether electrical stimulation of an area of the brain called 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.
Obese, non-diabetic people between 18 and 60 years of age who are in good health and who live in the Phoenix, AZ, metropolitan area are eligible for this study. Candidates must have a body mass index of 35 kg/m(2) or more and weigh less than 350 pounds.
Participants are admitted to the NIH inpatient unit in Phoenix for the first 9 days of the study for tests, which include meal tests to determine eating behaviors and caloric intake, blood and urine tests, glucose tolerance test, weight measurement, psychological assessments and DEXA scan to measure body fat. For 3 of the days, they will be asked to eat all of their food from automated vending machines. Some subjects receive transcranial direct current stimulation (TDCS). For this procedure, electrodes that conduct electricity are placed on the head and arm and the current is turned on for 40 minutes. Some tingling may be felt under the electrodes. Other subjects receive sham TDCS, with the current turned on only very briefly.
After the evaluations, subjects are discharged home from the NIH unit and instructed to eat 25 percent fewer calories than they consumed while on a weight maintenance diet the first 3 days of their inpatient stay. They maintain the lower calorie diet at home for 4 weeks. During this period they come to the NIH unit 3 days a week to receive either real or sham TDCS.
|Condition or disease||Intervention/treatment||Phase|
|Electric Stimulation Therapy Obesity Weight Loss Eating||Device: Transcranial Direct Current Stimulation (TDCS) Other: Sham/no-stimulation||Phase 2|
In our studies of brain function examining areas related to hunger and fullness, a part of the brain called the left dorsolateral prefrontal cortex (DLPFC) was found to be less active in obese versus lean individuals following a meal. Furthermore, in women who have lost and maintained weight loss, the activity in this area following a meal is similar to that of lean women, suggesting that the activity in this area may improve with weight loss. Two recent studies have demonstrated a lack of increase in food craving following non-invasive brain stimulation to the left DLPFC when compared to a sham control group that did not receive brain stimulation.
The aim of our protocol is to investigate the effectiveness of one type of noninvasive brain stimulation technique, transcranial direct current stimulation (TDCS) on food intake in significantly overweight (BMI greater than or equal to 30 kg/m(2) individuals. In study 1, we enrolled individuals who previously participated in this study and examined how anodal (active) stimulation or sham (no stimulation) to the left DLPFC compared to their previous stimulation condition in terms of both weight loss and food intake. The aim of Study 2 was to compare active versus sham anodal left DLPFC stimulation in a new group of volunteers.
Study 3 will be a 9 week double-blind parallel outpatient study where volunteers will come to the Clinical Research Unit 3x per week and be randomized to receive either active tDCS or "no stimulation" (sham) to the left DLPFC for stimulation sessions while being asked to follow a diet that is a 25% reduction from their calculated weight maintenance calories. The primary outcome measurement will be total food (kcal) intake during a snack food taste test, and weight change. Volunteers will also undergo 4 sessions of brain imaging (called functional MRI) to help us understand how the stimulation is working. Participants will also be asked to come back to the Unit after 6 months and 1 year for weight measurement. We will also examine appetitive hormones, neurocognitive and behavioral factors, which might also mediate potential changes in food intake and weight following TDCS to the left DLPFC. Positive findings from this study could demonstrate the utility of a novel and safe treatment for severe obesity. Future studies could include longer clinical trials of TDCS with extended follow-up durations.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||148 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||The Effects of Transcranial Direct Current Stimulation (TDCS) on Food Intake and Weight Loss|
|Actual Study Start Date :||January 19, 2009|
|Estimated Primary Completion Date :||July 31, 2022|
|Estimated Study Completion Date :||July 31, 2022|
active tDCS stimulation
Device: Transcranial Direct Current Stimulation (TDCS)
Active tDCS (anodal left DLPFC)
Sham Comparator: Sham
- Effect of tDCS on weight loss [ Time Frame: Screening, baseline, weeks 1-9, 6 months, 1 year ]Weight (kg)
- Effect of tDCS on brain fMRI activation in the left DLPFC when shown food vs. nonfood visual cues [ Time Frame: Weeks 1 and 9 ]Percent signal change in the left DLPFC when shown food vs. nonfood visual cues
- Effect of tDCS on food intake [ Time Frame: Baseline, week 9 ]Total energy intake during snack food taste test
- Effect of tDCS on macronutrient preferences [ Time Frame: Baseline, week 9 ]Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, macronutrient preferences determined during snack food taste test
- Effect of tDCS on responses to behavioral tests and neuropsychological performance tests [ Time Frame: Baseline, week 9 ]Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, performance on questionnaires
- Effect of tDCS on appetitive hormone levels [ Time Frame: Weeks 1 and 9 ]Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, appetitive hormone levels measured in blood
- Correlation between food intake and responses to behavioral tests and neuropsychological performance tests [ Time Frame: Baseline, week 9 ]Total energy intake during snack food taste test, performance on questionnaires
- Correlation between food intake and appetitive hormone levels [ Time Frame: Baseline, weeks 1 and 9 ]Total energy intake during snack food taste test, appetitive hormone levels measured in blood
- Correlation between weight change and responses to behavioral tests and neuropsychological performance tests [ Time Frame: Screening, baseline, weeks 1-9, 6 months, 1 year ]Weight (kg), performance on questionnaires
- Correlation between weight change and appetitive hormone levels [ Time Frame: Screening, baseline, weeks 1-9, 6 months, 1 year ]Weight (kg), appetitive hormone levels measured in blood
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00739362
|Contact: Marci Gluck, Ph.D.||(602) firstname.lastname@example.org|
|United States, Arizona|
|Banner Alzheimer's Institute||Recruiting|
|Phoenix, Arizona, United States, 85006|
|Phoenix, Arizona, United States, 85014|
|Contact: Marci Gluck, Ph.D. 602-200-5312 email@example.com|
|Principal Investigator:||Marci Gluck, Ph.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|