NCT02717247

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 7, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2019

Completed
Last Updated

January 9, 2020

Status Verified

January 1, 2020

Enrollment Period

3.2 years

First QC Date

March 7, 2016

Last Update Submit

January 6, 2020

Conditions

Overweight, Obesity and Other Hyperalimentation (E65-E68)

Keywords

tRNSFood addiction,ObesityCravingfunctional magnetic resonance imaging (fMRI)

Outcome Measures

Primary Outcomes (1)

  • Effects on craving frequencies

    by questionnaires scores and declarative number of food

    Change from baseline after 3 months

Secondary Outcomes (4)

  • change in body weight

    Change from baseline after 3 months

  • change in waist circumference

    Change from baseline after 3 months

  • change in body mass index

    Change from baseline after 3 months

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

    Change from baseline after 3 months

Study Arms (2)

Active tRNS treatment

EXPERIMENTAL

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

Placebo tRNS treatment

SHAM COMPARATOR

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

Interventions

Active tRNSDEVICE

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

Active tRNS treatment
Sham tRNSDEVICE

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.

Placebo tRNS treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Le Vinatier

Bron, 69678, France

Location

MeSH Terms

Conditions

OverweightObesityFood Addiction

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehaviorFeeding and Eating DisordersMental Disorders

Study Officials

  • D'AMATO THIERRY, PUPH

    CH LE VINATIER

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2016

First Posted

March 23, 2016

Study Start

February 1, 2016

Primary Completion

April 30, 2019

Study Completion

May 2, 2019

Last Updated

January 9, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)