search
Back to results

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

Primary Purpose

Overweight, Obesity and Other Hyperalimentation (E65-E68)

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Active tRNS
Sham tRNS
Sponsored by
Hôpital le Vinatier
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
March 7, 2016
Last Updated
January 6, 2020
Sponsor
Hôpital le Vinatier
search

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
Change from baseline after 3 months
Secondary Outcome Measure Information:
Title
change in body weight
Time Frame
Change from baseline after 3 months
Title
change in waist circumference
Time Frame
Change from baseline after 3 months
Title
change in body mass index
Time Frame
Change from baseline after 3 months
Title
change in biological markers such as lipid profile, ghrelin, leptin, prolactin
Time Frame
Change from baseline after 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
D'AMATO THIERRY, PUPH
Organizational Affiliation
CH LE VINATIER
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Le Vinatier
City
Bron Cedex
ZIP/Postal Code
69678
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Transcranial Random Noise Stimulation in Food Addiction Treatment

We'll reach out to this number within 24 hrs