Transcranial Random Noise Stimulation in Food Addiction Treatment - Clinical Trial for Overweight, Obesity and Other Hyperalimentation (E65-E68) | NCT02717247

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Primary Purpose

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Active tRNS

Sham tRNS

About this trial

This is an interventional treatment trial for Overweight, Obesity and Other Hyperalimentation (E65-E68) focused on measuring tRNS, Food addiction,, Obesity, Craving, functional magnetic resonance imaging (fMRI)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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 .

Sites / Locations

Centre Hospitalier Le Vinatier

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tRNS treatment

Placebo tRNS treatment

Arm 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

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.

Outcomes

Primary Outcome Measures

Effects on craving frequencies

by questionnaires scores and declarative number of food

Secondary Outcome Measures

change in body weight

change in waist circumference

change in body mass index

change in biological markers such as lipid profile, ghrelin, leptin, prolactin

Full Information

NCT ID

NCT02717247

First Posted

March 7, 2016

Last Updated

January 6, 2020

Sponsor

Hôpital le Vinatier

1. Study Identification

Unique Protocol Identification Number

NCT02717247

Brief Title

Transcranial Random Noise Stimulation in Food Addiction Treatment

Acronym

tRNS-FA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Terminated

Why Stopped

the princcipal investigator went abroad

Study Start Date

February 2016 (Actual)

Primary Completion Date

April 30, 2019 (Actual)

Study Completion Date

May 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hôpital le Vinatier

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight, Obesity and Other Hyperalimentation (E65-E68)

Keywords

tRNS, Food addiction,, Obesity, Craving, functional magnetic resonance imaging (fMRI)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active tRNS treatment

Arm Type

Experimental

Arm 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

Arm Title

Placebo tRNS treatment

Arm Type

Sham Comparator

Arm 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.

Intervention Type

Device

Intervention Name(s)

Active tRNS

Intervention 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 dorsolateral prefrontal cortex (F4). 100Hz-650Hz, 2mA, 30min, twice daily, 5 days

Intervention Type

Device

Intervention Name(s)

Sham tRNS

Intervention 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.

Primary Outcome Measure Information:

Title

Effects on craving frequencies

Description

by questionnaires scores and declarative number of food

Time Frame