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Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment

Primary Purpose

Electric Stimulation Therapy, Obesity, Weight Loss

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Transcranial Direct Current Stimulation (TDCS)

Sham/no-stimulation

About this trial

This is an interventional treatment trial for Electric Stimulation Therapy focused on measuring Behavioral Weight Loss Treatment, Obesity, Appetite Control, Weight Loss, Transcranial Direct Current Stimulation (TDCS)

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA:
BMI greater than or equal to 25 kg/m(2).
Age 18-60 years. Women who are post-menopausal will be excluded from the study due to changes in their metabolism that could affect weight loss. We will set the cutoff at age 60 so that the age difference between the men and women is not too great for analysis purposes. Minors under the age of 18 will be excluded because the time requirements of the study are such that they would interfere with school schedules.
Right-handedness (because the treatment will be given to the left dorsolateral prefrontal cortex and the evidence accumulated in this region was only in right-handed individuals)
Weight stable (plus or minus 5 percent) for last 3 months as determined by volunteer report.

EXCLUSION CRITERIA:

Weight > 300 lbs (136 kg), as this is the weight limit of the fMRI machine
Use of medication affecting metabolism and appetite in the last three months
Current pregnancy, pregnancy within the past 6 months or currently lactating
History or clinical manifestations of acute or chronic disorders or conditions that may affect appetite or energy expenditure (such as, but not limited to type 1 or type 2 diabetes, Cushing s disease, thyroid disorders, coccidiomycoses)
Gastrointestinal disease, including inflammatory bowel diseases (e.g. Chron s disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active) which may alter metabolism
Current, unstable medical conditions such as hepatitis, renal insufficiency, cancer requiring treatment in the last 5 years, or central nervous system disorders etc. as assessed by history and physical exam
Evidence of alcohol abuse as defined by greater than or equal to 8 point score on the Alcohol consumption screening AUDIT questionnaire in adults
Evidence of nicotine use or of drug use such as amphetamines, cocaine, heroin, or marijuana
Postmenopausal women or symptoms of perimenopause (e.g. hot flashes, onset of irregular periods following age 40, elevation of FSH >20 IU following age 40 years)
Any conditions contraindicated for MRI (e.g., pacemaker, metal in the cranial cavity, significant claustrophobia, holes in the skull made by trauma or surgery)
Any condition not specifically mentioned above that, in the opinion of the investigator, may interfere with the study or prove unsafe for participation.

Sites / Locations

NIDDK, PhoenixRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Sham Comparator

Active Comparator

Sham Comparator

Active Comparator

Sham Comparator

Arm Label

1-Sham

2-Active

2-Sham

3-Active

3-Sham

Arm Description

Active tDCS stimulation

Sham/no-stimulation

Active tDCS stimulation

Sham/no-stimulation

Outcomes

Primary Outcome Measures

weight loss

Weight (kg)

food intake

Total energy intake during snack food taste test

brain fMRI activation in the left DLPFC when shown food vs. nonfood visual cues

Percent signal change in the left DLPFC when shown food vs. nonfood visual cues

Secondary Outcome Measures

weight loss

weight (kg)

responses to Iowa Gambling Task

Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, performance on questionnaires

responses to Three Factor Eating Questionnaire

Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, performance on questionnaires

responses to MacArthur Scale of Subjective Social Status

Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, performance on questionnaires

responses to Gormally Binge Eating Questionnaire

Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, performance on questionnaires

weight loss

weight (kg)

responses to Perceived Stress Scale

Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, performance on questionnaires

GLP-1

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

Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, performance on questionnaires

Ghrelin

Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, appetitive hormone levels measured in blood

macronutrient preferences

Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, macronutrient preferences determined during snack food taste test

Full Information

NCT ID

NCT00739362

First Posted

August 20, 2008

Last Updated

October 20, 2023

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT00739362

Brief Title

Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment

Official Title

The Effects of Transcranial Direct Current Stimulation (TDCS) on Food Intake and Weight Loss

Study Type

Interventional

2. Study Status

Record Verification Date

May 18, 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 19, 2009 (Actual)

Primary Completion Date

July 30, 2024 (Anticipated)

Study Completion Date

July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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. ...

Detailed Description

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 >= 30 kg/m2) 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 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 measurements. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Electric Stimulation Therapy, Obesity, Weight Loss, Eating

Keywords

Behavioral Weight Loss Treatment, Obesity, Appetite Control, Weight Loss, Transcranial Direct Current Stimulation (TDCS)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1-Sham

Arm Type

Sham Comparator

Arm Description

Active tDCS stimulation

Arm Title

2-Active

Arm Type

Active Comparator

Arm Description

Active tDCS stimulation

Arm Title

2-Sham

Arm Type

Sham Comparator

Arm Description

Sham/no-stimulation

Arm Title

3-Active

Arm Type

Active Comparator

Arm Description

Active tDCS stimulation

Arm Title

3-Sham

Arm Type

Sham Comparator

Arm Description

Sham/no-stimulation

Intervention Type

Device

Intervention Name(s)

Transcranial Direct Current Stimulation (TDCS)

Intervention Description

Active tDCS (anodal left DLPFC)

Intervention Type

Other

Intervention Name(s)

Sham/no-stimulation

Intervention Description

Sham tDCS

Primary Outcome Measure Information:

Title

weight loss

Description

Weight (kg)

Time Frame

Baseline, week 9

Title

food intake

Description

Total energy intake during snack food taste test

Time Frame

Baseline, week 9

Title

brain fMRI activation in the left DLPFC when shown food vs. nonfood visual cues

Description

Percent signal change in the left DLPFC when shown food vs. nonfood visual cues

Time Frame

Weeks 1 and 9

Secondary Outcome Measure Information:

Title

weight loss

Description

weight (kg)

Time Frame

Baseline, 6 months

Title

responses to Iowa Gambling Task

Description

Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, performance on questionnaires

Time Frame

Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, appetitive hormone levels measured in blood

Title

responses to Three Factor Eating Questionnaire

Description

Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, performance on questionnaires

Time Frame

Baseline, week 9

Title

responses to MacArthur Scale of Subjective Social Status

Description

Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, performance on questionnaires

Time Frame

Baseline, week 9

Title

responses to Gormally Binge Eating Questionnaire

Description

Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, performance on questionnaires

Time Frame

Baseline, week 9

Title

weight loss

Description

weight (kg)

Time Frame

Baseline, 1 year

Title

responses to Perceived Stress Scale

Description

Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, performance on questionnaires

Time Frame

Baseline, week 9

Title

GLP-1

Description

Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, appetitive hormone levels measured in blood

Time Frame

Weeks 1 and 9

Title

responses to Go/No Go Task

Description

Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, performance on questionnaires

Time Frame

Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, appetitive hormone levels measured in blood

Title

Ghrelin

Description

Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, appetitive hormone levels measured in blood

Time Frame

Weeks 1 and 9

Title

macronutrient preferences

Description

Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, macronutrient preferences determined during snack food taste test

Time Frame

Baseline, week 9

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

INCLUSION CRITERIA: BMI greater than or equal to 25 kg/m(2). Age 18-60 years. Women who are post-menopausal will be excluded from the study due to changes in their metabolism that could affect weight loss. We will set the cutoff at age 60 so that the age difference between the men and women is not too great for analysis purposes. Minors under the age of 18 will be excluded because the time requirements of the study are such that they would interfere with school schedules. Right-handedness (because the treatment will be given to the left dorsolateral prefrontal cortex and the evidence accumulated in this region was only in right-handed individuals) Weight stable (plus or minus 5 percent) for last 3 months as determined by volunteer report. EXCLUSION CRITERIA: Weight > 300 lbs (136 kg), as this is the weight limit of the fMRI machine Use of medication affecting metabolism and appetite in the last three months Current pregnancy, pregnancy within the past 6 months or currently lactating History or clinical manifestations of acute or chronic disorders or conditions that may affect appetite or energy expenditure (such as, but not limited to type 1 or type 2 diabetes, Cushing s disease, thyroid disorders, coccidiomycoses) Gastrointestinal disease, including inflammatory bowel diseases (e.g. Chron s disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active) which may alter metabolism Current, unstable medical conditions such as hepatitis, renal insufficiency, cancer requiring treatment in the last 5 years, or central nervous system disorders etc. as assessed by history and physical exam Evidence of alcohol abuse as defined by greater than or equal to 8 point score on the Alcohol consumption screening AUDIT questionnaire in adults Evidence of nicotine use or of drug use such as amphetamines, cocaine, heroin, or marijuana Postmenopausal women or symptoms of perimenopause (e.g. hot flashes, onset of irregular periods following age 40, elevation of FSH >20 IU following age 40 years) Any conditions contraindicated for MRI (e.g., pacemaker, metal in the cranial cavity, significant claustrophobia, holes in the skull made by trauma or surgery) Any condition not specifically mentioned above that, in the opinion of the investigator, may interfere with the study or prove unsafe for participation.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kateri A Ware

Phone

(602) 200-5300

wareka@mail.nih.gov

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marci E Gluck, Ph.D.

Organizational Affiliation

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Official's Role

Principal Investigator

Facility Information:

Facility Name

NIDDK, Phoenix

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85014

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Office of Participant Recruitment-NIDDK

Phone

602-200-5315

niddkphoenixcontact@mail.nih.gov

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

26530931

Citation

Gluck ME, Alonso-Alonso M, Piaggi P, Weise CM, Jumpertz-von Schwartzenberg R, Reinhardt M, Wassermann EM, Venti CA, Votruba SB, Krakoff J. Neuromodulation targeted to the prefrontal cortex induces changes in energy intake and weight loss in obesity. Obesity (Silver Spring). 2015 Nov;23(11):2149-56. doi: 10.1002/oby.21313.

Results Reference

background

PubMed Identifier

17823419

Citation

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].

Results Reference

background

PubMed Identifier

29046305

Citation

Heinitz S, Reinhardt M, Piaggi P, Weise CM, Diaz E, Stinson EJ, Venti C, Votruba SB, Wassermann EM, Alonso-Alonso M, Krakoff J, Gluck ME. Neuromodulation directed at the prefrontal cortex of subjects with obesity reduces snack food intake and hunger in a randomized trial. Am J Clin Nutr. 2017 Dec;106(6):1347-1357. doi: 10.3945/ajcn.117.158089. Epub 2017 Oct 18.

Results Reference

background

PubMed Identifier

36052819

Citation

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.

Results Reference

derived

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Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment

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