Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02717247
Recruitment Status : Recruiting
First Posted : March 23, 2016
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Overweight, Obesity and Other Hyperalimentation (E65-E68) Device: Active tRNS Device: Sham tRNS Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Transcranial Random Noise Stimulation of Prefrontal Cortex on Craving Supply Subject Suffering From Obesity
Actual Study Start Date : February 2016
Estimated Primary Completion Date : September 28, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Noise

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.




Primary Outcome Measures :
  1. Effects on craving frequencies [ Time Frame: Change from baseline after 3 months ]
    by questionnaires scores and declarative number of food


Secondary Outcome Measures :
  1. change in body weight [ Time Frame: Change from baseline after 3 months ]
  2. change in waist circumference [ Time Frame: Change from baseline after 3 months ]
  3. change in body mass index [ Time Frame: Change from baseline after 3 months ]
  4. change in biological markers such as lipid profile, ghrelin, leptin, prolactin [ Time Frame: Change from baseline after 3 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717247


Contacts
Layout table for location contacts
Contact: D'AMATO THIERRY, PUPH 003337915100 thierry.damato@ch-le-vinatier.fr
Contact: ICETA SYLVAIN, PH 0033427857769 sylvain.iceta@chu-lyon.fr

Locations
Layout table for location information
France
Centre Hospitalier Le Vinatier Recruiting
Bron Cedex, France, 69678
Contact: Thierry D'AMATO, PH    04 37 91 51 00    thierry.damato@ch-le-vinatier.fr   
Sponsors and Collaborators
Hôpital le Vinatier
Investigators
Layout table for investigator information
Principal Investigator: D'AMATO THIERRY, PUPH CH LE VINATIER

Layout table for additonal information
Responsible Party: Hôpital le Vinatier
ClinicalTrials.gov Identifier: NCT02717247     History of Changes
Other Study ID Numbers: 2015-A00028-41
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hôpital le Vinatier:
tRNS
Food addiction,
Obesity
Craving
functional magnetic resonance imaging (fMRI)
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Overweight
Hyperphagia
Food Addiction
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Feeding and Eating Disorders
Mental Disorders
Signs and Symptoms, Digestive