Overweight, Obesity and Other Hyperalimentation (E65-E68)tRNS-FANCT02717247
Transcranial Random Noise Stimulation in Food Addiction Treatment
A study testing Active tRNS in people with Overweight, Obesity and Other Hyperalimentation (E65-E68), run by Hôpital le Vinatier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight, Obesity and Other Hyperalimentation (E65-E68)
- What is being tested?
- Active tRNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2016to 2 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Active tRNS, Sham tRNS
- Keywords
- tRNS, Food addiction,, Obesity, Craving, functional magnetic resonance imaging (fMRI)
- Medical subject headings
- Overweight, Obesity, Food Addiction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Sham tRNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects on craving frequencies
by questionnaires scores and declarative number of food
Measured: Change from baseline after 3 months
Secondary outcomes (4)
change in body weight
Measured: Change from baseline after 3 months
change in waist circumference
Measured: Change from baseline after 3 months
change in body mass index
Measured: Change from baseline after 3 months
change in biological markers such as lipid profile, ghrelin, leptin, prolactin
Measured: Change from baseline after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completion30 Apr 2019
- Study completion2 May 2019
Why it stopped: the princcipal investigator went abroad
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight, Obesity and Other Hyperalimentation (E65-E68)Studies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- D'AMATO THIERRY, PUPH, Principal investigator, CH LE VINATIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717247
- Sponsor's protocol ID
- 2015-A00028-41
- Acronym
- tRNS-FA
- Status last verified
- Jan 2020
- First submitted
- 7 Mar 2016
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcranial Random Noise Stimulation of Prefrontal Cortex on Craving Supply Subject Suffering From Obesity
- ClinicalTrials.gov ID
- NCT02717247
- Acronym / sponsor ID
- tRNS-FA / 2015-A00028-41
- Keywords
- tRNS, Food addiction,, Obesity, Craving, functional magnetic resonance imaging (fMRI)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the princcipal investigator went abroad
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 2 May 2019 (actual)
- First posted
- 23 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tRNS treatment | Experimental | Device: Active tRNSThe 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 |
| Placebo tRNS treatment | Sham comparator | Device: Sham tRNSThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active tRNSThe 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 | Device | Active tRNS treatment |
| Sham tRNSThe 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 | Placebo tRNS treatment |
Primary outcome
Effects on craving frequencies
Time frame: Change from baseline after 3 months
by questionnaires scores and declarative number of food
4 secondary outcomes
change in body weight
Time frame: Change from baseline after 3 months
change in waist circumference
Time frame: Change from baseline after 3 months
change in body mass index
Time frame: Change from baseline after 3 months
change in biological markers such as lipid profile, ghrelin, leptin, prolactin
Time frame: Change from baseline after 3 months
Results and safety
The study was stopped early (reason given: the princcipal investigator went abroad). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Individual participant dataSharing planned: No
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Overweight, Obesity and Other Hyperalimentation (E65-E68)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
D'AMATO THIERRY, PUPH principal investigator
CH LE VINATIER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tRNS in people with Overweight, Obesity and Other Hyperalimentation (E65-E68), run by Hôpital le Vinatier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: the princcipal investigator went abroad). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects on craving frequencies (time frame: Change from baseline after 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.