Transcranial Random Noise Stimulation in Food Addiction Treatment

Study Overview
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Brief Summary
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Obesity is worldwide a public health problem. According to World Health Organization (WHO), overweight and obesity are the fifth death risk factor worldwide. At least 2.8 million adults die each year. Food addiction is one of the causes of obesity that may benefit from new therapeutic options.

Detailed Description
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Transcranial random noise stimulation is a noninvasive brain stimulation technic. The modulation of the electrical activity of the right and left dorsolateral prefrontal cortex (DLPFC) by tRNS is able to act on the phenomenon of craving in other addictions. This allows us to make the assumption that tRNS stimulation could constitute a treatment for food addiction especially in obesity.

Official Title
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Effect of Transcranial Random Noise Stimulation of Prefrontal Cortex on Craving Supply Subject Suffering From Obesity

Conditions
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Overweight, Obesity and Other Hyperalimentation (E65-E68)

Intervention / Treatment
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* Device: Active tRNS
* Device: Sham tRNS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female or male between 18 and 65 years old Patients suffering from obesity, with a BMI ≥ 30. Food dependence score at the Yale Food addiction Scale ≥ 3 Exclusion Criteria: Presence of a an other psychiatric diagnosis of Axis I (DSM IV); Presence of addictive comorbidity other than food addiction Psychotropic treatment; Pregnancy or lactation; Contraindication to fMRI .

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active tRNS treatment<br>The intervention consists in active tRNS stimulation with cathode above the left dorsolateral prefrontal cortex (DLPFC) which corresponds to the F3 location given by the 10-20 system. Anode is above the right dorsalateral prefrontal cortex (F4). 100 (Hertz)Hz-650Hz, 2milliampere(mA), 30min, twice daily, 5 days | Device: Active tRNS<br>* The intervention consists in active tRNS stimulation with cathode above the left dorsolateral prefrontal cortex (DLPFC) which corresponds to the F3 location given by the 10-20 system. Anode is above the right dorsolateral prefrontal cortex (F4). 100Hz-650Hz, 2mA, 30min, twice daily, 5 days<br>|
| Sham Comparator: Placebo tRNS treatment<br>The intervention consists in placebo or sham tRNS stimulation electrode are above F3 and F4. Voltage will be ramped at the begin and end of a stimulation for 30 seconds. Placebo stimulation will consist of just applying the ramps at the begin and end of the stimulation. | Device: Sham tRNS<br>* The intervention consists in placebo or sham tRNS stimulation electrode are above F3 and F4. Voltage will be ramped at the begin and end of a stimulation for 30 seconds. Placebo stimulation will consist of just applying the ramps at the begin and end of the stimulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on craving frequencies | by questionnaires scores and declarative number of food | Change from baseline after 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in body weight |  | Change from baseline after 3 months | 
| change in waist circumference |  | Change from baseline after 3 months | 
| change in body mass index |  | Change from baseline after 3 months | 
| change in biological markers such as lipid profile, ghrelin, leptin, prolactin |  | Change from baseline after 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tRNS, Food addiction,, Obesity, Craving, functional magnetic resonance imaging (fMRI)