Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 3/10/2019 |
| Start Date: | August 4, 2008 |
| End Date: | January 30, 2025 |
| Contact: | Marci Gluck, Ph.D. |
| Email: | gmarci@mail.nih.gov |
| Phone: | (602) 200-5312 |
The Effects of Transcranial Direct Current Stimulation (TDCS) on Food Intake and Weight Loss
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.
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.
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.
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.
- INCLUSION CRITERIA:
- BMI greater than or equal to 30 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.
Additionally, while the risks of tDCS are minimal, there haven t been studies showing
how tDCS might affect the growing brain.
- Healthy, as determined by medical history, physical examination, and laboratory tests
- 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
EXCLUSION CRITERIA:
- Weight less than 350 lbs, as this is the weight limit of the DXA machine
- Type 2 diabetes (according to the World Health Organization diagnostic criteria)
- Endocrine disorders (Cushing s disease, pituitary disorders, and hypo- and
hyperthyroidism)
- Chronic pulmonary disorders, including chronic obstructive pulmonary disease that
would limit ability to follow the protocol (investigator judgment) and obstructive
sleep apnea syndrome; only subjects with mild or exercise-induced asthma on no
medications or on beta-adrenergic agonists only (such as albuterol) will be allowed to
enter the study (provided use of these agents is not required for 1 week before study
entry).
- Cardiovascular diseases (coronary heart disease, heart failure, arrhythmias, and
peripheral artery disease)
- Hypertension (blood pressure measurement higher than 140/90 mmHg on 2 or more
occasions or use of anti-hypertensive medications)
- Diagnosed gastrointestinal diseases, including inflammatory bowel diseases (e.g. Crohn
s disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease),
gastric ulcer (active); only subjects with gastro-esophageal reflux will be allowed to
enter the study
- Liver disease (cirrhosis, active hepatitis B or C, and AST or ALT greater than or
equal to 1.5 times normal)
- Renal disease (serum creatinine concentrations greater than or equal to 1.5 mg/dl
and/or overt proteinuria)
- Central nervous system disease (cerebrovascular accidents, dementia, neurodegenerative
disorders, epilepsy or history of head injury). Personal or first-degree relative with
a seizure history.
- Cancer requiring treatment in the past 5 years, except for non-melanoma skin cancers
or cancers that have clearly been cured or, in the opinion of the investigator, carry
an excellent prognosis (e.g., Stage 1 cervical cancer)
- Alcohol (more than 3 drinks per day) and/or drug abuse (such as amphetamines, cocaine,
heroin, or marijuana)
- Smoking more than 5 cigarettes per day
- Current psychiatric disorder, as diagnosed by the Structured Clinical Interview for
DSM-V. Those who report suicidal ideation or clinically significant problems will be
immediately referred for appropriate treatment.
- Presence of metal in the cranial cavity
- Holes in the skull made by trauma or surgery
- Pregnancy or lactation. All women (who could bear children) not using a medically
approved method of contraception (surgical sterilization, intrauterine device, or a
combined method using at least 2 of the following: diaphragm, condom, spermicide) will
be excluded.
- Postmenopausal women or symptoms of perimenopause (e.g. hot flashes, onset of
irregular periods following age 40, elevation of FSH greater than 20 IU following age
40 years)
- Taking weight loss medications or psychotropic medication
- History of HIV infection or ongoing chronic infection (such as tuberculosis)
- Conditions not specifically mentioned above may serve as criteria for exclusion at the
discretion of the investigators.
- Any conditions contraindicated for MRI (e.g., pacemaker, metal in body, significant
claustrophobia).
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