Food Addiction, Obesity, Morbid
Conditions
Brief summary
This experiment is based on a unique technique of deep Transcranial magnetic stimulation (dTMS) of the brain's cortex, aiming to produce weight loss in food-addicted severely obese adults.
Detailed description
The neurobiological underpinnings of food addiction in obesity point to chemical, structural and functional imbalance in the mesolimbic dopaminergic brain system. This may cause symptoms of altered reward processing, excessive cravings for hyperpalatable food and repeated self-regulation failures to control food intake in this population. Specifically, the medial prefrontal cortex (mPFC), anterior cingulate cortex (ACC) and deeper reward-related brain regions function differentially from healthy controls and similarly to individuals with substance or behavioral addiction. Deep transcranial magnetic stimulation of the mPFC has been shown efficacious in reducing cravings and other addictive symptoms in individuals with SUD, as well as symptoms of compulsivity in obsessive compulsive disorder (OCD). In this study the investigators use deep transcranial magnetic stimulation (dTMS) with an H-coil to safely stimulate the mPFC and deeper brain regions, in individuals with obesity and food addiction. The investigators aim to produce neuroplasticity favoring the restoration of mPFC functioning, alleviating food addiction symptoms and promoting weight loss.
Interventions
DEVICEdTMS with mPFC stimulation
dTMS with Brainsway's H7 device, stimulating the mPFC.
Sponsors
Soroka University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 30 ≤ BMI ≥ 50. * Having had at least one prior conventional weight loss attempt, but no current weight loss attempts or over the last 3 months. * Having satisfied a safety screening questionnaire for TMS (Keel, 2001) * Omnivorous * Have not had experience with TMS of any kind *
Exclusion criteria
* They experience tremor in any limb. * They experience seizures. * They have a history of epilepsy or seizure (EXCEPT those therapeutically induced by ECT, or febrile childhood seizures). * They are at increased risk for seizures for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or a history of significant head trauma with loss of consciousness for \> 5 minutes. * A history of clinically significant neurological disorders, including organic brain disease, epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery or personal history of head trauma that resulted in loss of consciousness for \> 5 minutes and retrograde amnesia for \> 30 minutes (self-reported history). * They have a clinically significant hearing impairment, unless a medical letter is provided permitting the participant to receive a dTMS treatment. * The participant has an unstable physical disease, such as acute unstable cardiac disease, or high blood pressure (\>150 mmHg, systolic/\> 110 mmHg diastolic, unless a medical letter is provided permitting the participant to receive a dTMS treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in BMI | Change in BMI between baseline and the end of the treatment (day 15) and follow-up (a month after day 15) | Unit of measure: BMI in kg/m\^2 (weight in kilograms, height in meters) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive regulation of eating | The change in reaction time on the Food Stroop task between day 15 and baseline. | Cognitive regulation of eating will be assessed with a computerized Food Stroop task. A change in reaction time (milliseconds) in response to high-calorie food, low-calorie food, and non-food items will be assessed. |
| Depressive symptoms | A change in BDI score from baseline to day 15. | Depressive symptoms will be assessed with the 21-question multiple-choice self-report inventory, the Beck Depression Inventory (BDI). The highest possible total for the whole test would be sixty-three and the lowest possible score for the test would be zero. |
| Eating behavior [cognitive restraint (CR), emotional eating (EE), uncontrollable eating (UE)] will be assessed with the Three Factor Eating Questionnaire (TFEQ). | The change in these parameters will be assessed between baseline and day 15. | The TFEQ measures CR, EE, and UE. A change (decrease or increase) in the symptoms of each of the scales will be assessed at the end of the intervention and at follow up. |
| Eating behavior [restrictive eating (RE), emotional eating (EME), external eating (EXE)] will be assessed with the Dutch Eating Behavior Questionnaire (DEBQ) | The change in these parameters will be assessed between baseline and day 15. | The DEBQ measures RE, EME and EXE, A change (decrease or increase) in the symptoms of each of the scales will be assessed at the end of the intervention and at follow up. |
| Change in food addiction symptoms on the Yale Food Addiction Scale (YFAS) | The change in the number of symptoms on day 15 compared to baseline will be assessed. | The YFAS includes 1-7 symptoms, while participants are recruited to the study if they have 3 symptoms or more. The greater the symptoms, the more food addiction the participants experience. |
| Binge eating frequency | The change in binge eating frequency between baseline and day 15. | Binge eating will be assessed with the Eating disorder examination-questionnaire with Instructions (EDE-Q-I). This questionnaire assesses binge eating frequency over the past 28 days. |
| Quality of life | The change in the SF-36 score between baseline and day 15. | Health Status Scale Short-form 36 (SF-36) |
| General mood | The change in the overall score (positive affect minus negative affect) between baseline and day 15. | Positive Affect Negative Affect Schedule (PANAS). |
| Eating behavior [restrictive eating (RE), emotional eating (EME), external eating (EXE)] | The change in these parameters will be assessed between day 16 (a month after day 15) and baseline. | The DEBQ measures RE, EME and EXE, A change (decrease or increase) in the |
Countries
Israel
Contacts
Primary ContactAbraham Zangen, PhD
Backup ContactShahar Atias, MD
Outcome results
None listed