Transcranial Random Noise Stimulation in Food Addiction Treatment (tRNS-FA)

Hôpital le Vinatier

Status: Terminated

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

Treatments: Device: Active tRNS; Device: Sham tRNS

Study type: Interventional

Funder types: Other

Identifiers

NCT02717247

2015-A00028-41

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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13 participants in 2 patient groups

Active tRNS treatment

Experimental group

Description:

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

Treatment:

Device: Active tRNS

Placebo tRNS treatment

Sham Comparator group

Description:

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.

Treatment:

Device: Sham tRNS