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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
dTMS with Brainsway's H7 device, stimulating the mPFC.
Soroka University Medical Center
Beersheba, Israel
RECRUITINGChange in BMI
Unit of measure: BMI in kg/m\^2 (weight in kilograms, height in meters)
Time frame: Change in BMI between baseline and the end of the treatment (day 15) and follow-up (a month after day 15)
Change in BMI
Unit of measure: BMI in kg/m\^2 (weight in kilograms, height in meters)
Time frame: Change in BMI between baseline and follow-up (a month after day 15)
Change in food addiction symptoms on the Yale Food Addiction Scale (YFAS)
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.
Time frame: The change in the number of symptoms on day 15 compared to baseline will be assessed.
Change in food addiction symptoms on the Yale Food Addiction Scale (YFAS)
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.
Time frame: The change in the number of symptoms on day 16 (a month after day 15) compared to baseline will be assessed.
Cognitive regulation of eating
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.
Time frame: The change in reaction time on the Food Stroop task between day 15 and baseline.
Cognitive regulation of eating
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.
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Time frame: The change in reaction time on the Food Stroop task between day 16 (a month after day 15) and baseline.
Depressive symptoms
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.
Time frame: A change in BDI score from baseline to day 15.
Depressive symptoms
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.
Time frame: A change in BDI score from baseline to day 16.
Eating behavior [cognitive restraint (CR), emotional eating (EE), uncontrollable eating (UE)] will be assessed with the Three Factor Eating Questionnaire (TFEQ).
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.
Time frame: The change in these parameters will be assessed between baseline and day 15.
Eating behavior [cognitive restraint (CR), emotional eating (EE), uncontrollable eating (UE)] will be assessed with the Three Factor Eating Questionnaire (TFEQ).
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.
Time frame: The change in these parameters will be assessed between day 16 (a month after day 15) and baseline.
Eating behavior [restrictive eating (RE), emotional eating (EME), external eating (EXE)] will be assessed with the Dutch Eating Behavior Questionnaire (DEBQ)
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.
Time frame: The change in these parameters will be assessed between baseline and day 15.
Eating behavior [restrictive eating (RE), emotional eating (EME), external eating (EXE)]
The DEBQ measures RE, EME and EXE, A change (decrease or increase) in the
Time frame: The change in these parameters will be assessed between day 16 (a month after day 15) and baseline.
Binge eating frequency
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.
Time frame: The change in binge eating frequency between baseline and day 15.
Binge eating frequency
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.
Time frame: The change in binge eating frequency between baseline and day 16.
Quality of life
Health Status Scale Short-form 36 (SF-36)
Time frame: The change in the SF-36 score between baseline and day 15.
Quality of life
Health Status Scale Short-form 36 (SF-36)
Time frame: The change in the SF-36 score between baseline and day 16.
General mood
Positive Affect Negative Affect Schedule (PANAS).
Time frame: The change in the overall score (positive affect minus negative affect) between baseline and day 15.
General mood
Positive Affect Negative Affect Schedule (PANAS).
Time frame: The change in the overall score (positive affect minus negative affect) between baseline and day 16.