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the princcipal investigator went abroad
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tRNS treatment | Experimental | 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 |
|
| Placebo tRNS treatment | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active tRNS | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Effects on craving frequencies | by questionnaires scores and declarative number of food | Change from baseline after 3 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| D'AMATO THIERRY, PUPH | CH LE VINATIER | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Le Vinatier | Bron | 69678 | France |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D000073932 | Food Addiction |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Sham tRNS | Device | 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. |
|
| Change from baseline after 3 months |
| change in biological markers such as lipid profile, ghrelin, leptin, prolactin | Change from baseline after 3 months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016739 | Behavior, Addictive |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |