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

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

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.

Study Overview

• Status: Terminated
• Conditions: Overweight, Obesity and Other Hyperalimentation (E65-E68)
• Intervention / Treatment: Device: Active tRNS; Device: Sham tRNS

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron Cedex, France, 69678
    • Centre Hospitalier Le Vinatier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Active tRNS treatment; 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; 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
SHAM_COMPARATOR: Placebo tRNS treatment; 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; 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.

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Hôpital le Vinatier
• Investigators: Principal Investigator: D'AMATO THIERRY, PUPH, CH Le Vinatier

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2016
• Primary Completion (ACTUAL): April 30, 2019
• Study Completion (ACTUAL): May 2, 2019

Study Registration Dates

• First Submitted: March 7, 2016
• First Submitted That Met QC Criteria: March 17, 2016
• First Posted (ESTIMATE): March 23, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 9, 2020
• Last Update Submitted That Met QC Criteria: January 6, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Obesity; Craving; functional magnetic resonance imaging (fMRI); tRNS; Food addiction,
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Overnutrition; Nutrition Disorders; Body Weight; Compulsive Behavior; Impulsive Behavior; Behavior, Addictive; Obesity; Overweight; Food Addiction; Hyperphagia
• Other Study ID Numbers: 2015-A00028-41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO