Transcranial Random Noise Stimulation in Food Addiction Treatment

Overweight, Obesity and Other Hyperalimentation (E65-E68) Clinical Trial

— tRNS-FA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02717247
• Other study ID #: 2015-A00028-41
• Status: Terminated
• Phase: N/A
• Start date: February 2016
• Est. completion date: May 2, 2019

Study information

• Verified date: January 2020
• Source: Hôpital le Vinatier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: May 2, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Food Addiction
• Hyperphagia
• Obesity
• Overweight
• Overweight, Obesity and Other Hyperalimentation (E65-E68)

Intervention

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 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.

Locations

Country	Name	City	State
France	Centre Hospitalier Le Vinatier	Bron Cedex

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects on craving frequencies	by questionnaires scores and declarative number of food	Change from baseline after 3 months
Secondary	change in body weight		Change from baseline after 3 months
Secondary	change in waist circumference		Change from baseline after 3 months
Secondary	change in body mass index		Change from baseline after 3 months
Secondary	change in biological markers such as lipid profile, ghrelin, leptin, prolactin		Change from baseline after 3 months