Transcranial Random Noise Stimulation in Food Addiction Treatment (tRNS-FA)
January 6, 2020 updated by: Hôpital le Vinatier
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bron Cedex, France, 69678
- Centre Hospitalier Le Vinatier
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
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 |
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.
|
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
Time Frame: Change from baseline after 3 months
|
by questionnaires scores and declarative number of food
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Change from baseline after 3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
change in body weight
Time Frame: Change from baseline after 3 months
|
Change from baseline after 3 months
|
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change in waist circumference
Time Frame: Change from baseline after 3 months
|
Change from baseline after 3 months
|
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change in body mass index
Time Frame: Change from baseline after 3 months
|
Change from baseline after 3 months
|
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change in biological markers such as lipid profile, ghrelin, leptin, prolactin
Time Frame: Change from baseline after 3 months
|
Change from baseline after 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: D'AMATO THIERRY, PUPH, Ch Le Vinatier
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-A00028-41
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.