Transcranial Random Noise Stimulation in Food Addiction Treatment

Not Applicable

Terminated

• Conditions: Overweight, Obesity and Other Hyperalimentation (E65-E68)
• Interventions: Device: Active tRNS; Device: Sham tRNS

• Registration Number: NCT02717247
• Lead Sponsor: Hôpital le Vinatier

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-03-07
• Study First Submitted QC: 2016-03-17
• Study First Posted: 2016-03-23
• Primary Completion: 2019-04-30
• Study Completion: 2019-05-02
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active tRNS treatment	Active tRNS	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 tRNS	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.

Primary Outcome Measures

Name	Time	Method
Effects on craving frequencies	Change from baseline after 3 months	by questionnaires scores and declarative number of food

Secondary Outcome Measures

Name	Time	Method
change in biological markers such as lipid profile, ghrelin, leptin, prolactin	Change from baseline after 3 months
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

Trial Locations

Locations (1)

Centre Hospitalier Le Vinatier; 🇫🇷 Bron Cedex, France