Food AddictionFAOB-mPFCNCT04692909
Deep Transcranial Magnetic Stimulation (dTMS) of the Medial Prefrontal Cortex in Food Addiction and Obesity
A study testing dTMS with mPFC stimulation in people with Food Addiction and Obesity, Morbid, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
This experiment is based on a unique technique of deep Transcranial magnetic stimulation (dTMS) of the brain's cortex, aiming to produce weight loss in food-addicted severely obese adults. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Food Addiction, Obesity, Morbid
- What is being tested?
- dTMS with mPFC stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Jan 2021to 1 Dec 2022
- 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
- 30 ≤ BMI ≥ 50.
- Having had at least one prior conventional weight loss attempt, but no current weight loss attempts or over the last 3 months.
- Having satisfied a safety screening questionnaire for TMS (Keel, 2001)
- Omnivorous
- Have not had experience with TMS of any kind
Who cannot join
- They experience tremor in any limb.
- They experience seizures.
- They have a history of epilepsy or seizure (EXCEPT those therapeutically induced by ECT, or febrile childhood seizures).
- They are at increased risk for seizures for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or a history of significant head trauma with loss of consciousness for > 5 minutes.
- A history of clinically significant neurological disorders, including organic brain disease, epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery or personal history of head trauma that resulted in loss of consciousness for > 5 minutes and retrograde amnesia for > 30 minutes (self-reported history).
- They have a clinically significant hearing impairment, unless a medical letter is provided permitting the participant to receive a dTMS treatment.
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- The participant has an unstable physical disease, such as acute unstable cardiac disease, or high blood pressure (>150 mmHg, systolic/> 110 mmHg diastolic, unless a medical letter is provided permitting the participant to receive a dTMS treatment.
- They experience tremor in any limb.
- They experience seizures.
- They have a history of epilepsy or seizure (EXCEPT those therapeutically induced by ECT, or febrile childhood seizures).
- They are at increased risk for seizures for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or a history of significant head trauma with loss of consciousness for > 5 minutes.
- A history of clinically significant neurological disorders, including organic brain disease, epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery or personal history of head trauma that resulted in loss of consciousness for > 5 minutes and retrograde amnesia for > 30 minutes (self-reported history).
- They have a clinically significant hearing impairment, unless a medical letter is provided permitting the participant to receive a dTMS treatment.
- The participant has an unstable physical disease, such as acute unstable cardiac disease, or high blood pressure (>150 mmHg, systolic/> 110 mmHg diastolic, unless a medical letter is provided permitting the participant to receive a dTMS treatment.
- The participant is at a high risk for severe violence or suicidal tendencies, has current DSM5 diagnosis of schizophrenia, bipolar disorder, or other psychotic disorder, as reported during the screening interview (see appendix 3).
- The participant has metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neuro-stimulators, intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or implanted medical pumps.
- The participant is having, or has had, any metal in the head (outside the mouth).
- The participant has any cognitive or functional disability, according to criteria specified in the DSM-V, such as active and unstable psychiatric disorder according to DSM-V (Axis I and Axis II), diagnosed within the last year.
- The participant has started or changed a psychotropic prescription within the past three months.
- The participant has current alcohol or other substance abuse or dependence, or has had one over the past 12 months prior to recruitment.
- The participant can't reliably communicate with the investigator, or is unlikely to cope with the requirements of the experiment.
- The participant is having a known or suspected pregnancy or lactation.
- The motor threshold can't be found or quantified.
- The PI decides that the participant should be withdrawn from the study for the safety and welfare of the participant. For example, the participant experiences adverse event which is contraindicated with the continuation in the study.
- The participant has a history of intolerance to a TMS treatment. The participant asks for withdrawal.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Soroka University Medical Center
Beersheba
Shahar Atias, MD, 972544783129, atiassh@yahoo.com
About this study
Official title: Deep Transcranial Magnetic Stimulation (dTMS) of the Medial Prefrontal Cortex (mPFC) in Food Addiction and Obesity
This experiment is based on a unique technique of deep Transcranial magnetic stimulation (dTMS) of the brain's cortex, aiming to produce weight loss in food-addicted severely obese adults.
Read the detailed description
The neurobiological underpinnings of food addiction in obesity point to chemical, structural and functional imbalance in the mesolimbic dopaminergic brain system. This may cause symptoms of altered reward processing, excessive cravings for hyperpalatable food and repeated self-regulation failures to control food intake in this population. Specifically, the medial prefrontal cortex (mPFC), anterior cingulate cortex (ACC) and deeper reward-related brain regions function differentially from healthy controls and similarly to individuals with substance or behavioral addiction. Deep transcranial magnetic stimulation of the mPFC has been shown efficacious in reducing cravings and other addictive symptoms in individuals with SUD, as well as symptoms of compulsivity in obsessive compulsive disorder (OCD). In this study the investigators use deep transcranial magnetic stimulation (dTMS) with an H-coil to safely stimulate the mPFC and deeper brain regions, in individuals with obesity and food addiction. The investigators aim to produce neuroplasticity favoring the restoration of mPFC functioning, alleviating food addiction symptoms and promoting weight loss.
- Conditions
- Food Addiction, Obesity, Morbid
- Being tested
- dTMS with mPFC stimulation
- Medical subject headings
- Food Addiction, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dTMS with mPFC stimulationDevice
dTMS with Brainsway's H7 device, stimulating the mPFC.
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Active dTMS Receives: Device: dTMS with mPFC stimulation |
| Placebo | Placebo comparator | Placebo dTMS Receives: Device: dTMS with mPFC stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI
Unit of measure: BMI in kg/m^2 (weight in kilograms, height in meters)
Measured: Change in BMI between baseline and the end of the treatment (day 15) and follow-up (a month after day 15)
Change in BMI
Unit of measure: BMI in kg/m^2 (weight in kilograms, height in meters)
Measured: Change in BMI between baseline and follow-up (a month after day 15)
Secondary outcomes (16)
Change in food addiction symptoms on the Yale Food Addiction Scale (YFAS)
The YFAS includes 1-7 symptoms, while participants are recruited to the study if they have 3 symptoms or more. The greater the symptoms, the more food addiction the participants experience.
Measured: The change in the number of symptoms on day 15 compared to baseline will be assessed.
Change in food addiction symptoms on the Yale Food Addiction Scale (YFAS)
The YFAS includes 1-7 symptoms, while participants are recruited to the study if they have 3 symptoms or more. The greater the symptoms, the more food addiction the participants experience.
Measured: The change in the number of symptoms on day 16 (a month after day 15) compared to baseline will be assessed.
Cognitive regulation of eating
Cognitive regulation of eating will be assessed with a computerized Food Stroop task. A change in reaction time (milliseconds) in response to high-calorie food, low-calorie food, and non-food items will be assessed.
Measured: The change in reaction time on the Food Stroop task between day 15 and baseline.
Cognitive regulation of eating
Cognitive regulation of eating will be assessed with a computerized Food Stroop task. A change in reaction time (milliseconds) in response to high-calorie food, low-calorie food, and non-food items will be assessed.
Measured: The change in reaction time on the Food Stroop task between day 16 (a month after day 15) and baseline.
Depressive symptoms
Depressive symptoms will be assessed with the 21-question multiple-choice self-report inventory, the Beck Depression Inventory (BDI). The highest possible total for the whole test would be sixty-three and the lowest possible score for the test would be zero.
Measured: A change in BDI score from baseline to day 15.
Depressive symptoms
Depressive symptoms will be assessed with the 21-question multiple-choice self-report inventory, the Beck Depression Inventory (BDI). The highest possible total for the whole test would be sixty-three and the lowest possible score for the test would be zero.
Measured: A change in BDI score from baseline to day 16.
Eating behavior [cognitive restraint (CR), emotional eating (EE), uncontrollable eating (UE)] will be assessed with the Three Factor Eating Questionnaire (TFEQ).
The TFEQ measures CR, EE, and UE. A change (decrease or increase) in the symptoms of each of the scales will be assessed at the end of the intervention and at follow up.
Measured: The change in these parameters will be assessed between baseline and day 15.
Eating behavior [cognitive restraint (CR), emotional eating (EE), uncontrollable eating (UE)] will be assessed with the Three Factor Eating Questionnaire (TFEQ).
The TFEQ measures CR, EE, and UE. A change (decrease or increase) in the symptoms of each of the scales will be assessed at the end of the intervention and at follow up.
Measured: The change in these parameters will be assessed between day 16 (a month after day 15) and baseline.
Eating behavior [restrictive eating (RE), emotional eating (EME), external eating (EXE)] will be assessed with the Dutch Eating Behavior Questionnaire (DEBQ)
The DEBQ measures RE, EME and EXE, A change (decrease or increase) in the symptoms of each of the scales will be assessed at the end of the intervention and at follow up.
Measured: The change in these parameters will be assessed between baseline and day 15.
Eating behavior [restrictive eating (RE), emotional eating (EME), external eating (EXE)]
The DEBQ measures RE, EME and EXE, A change (decrease or increase) in the
Measured: The change in these parameters will be assessed between day 16 (a month after day 15) and baseline.
Binge eating frequency
Binge eating will be assessed with the Eating disorder examination-questionnaire with Instructions (EDE-Q-I). This questionnaire assesses binge eating frequency over the past 28 days.
Measured: The change in binge eating frequency between baseline and day 15.
Binge eating frequency
Binge eating will be assessed with the Eating disorder examination-questionnaire with Instructions (EDE-Q-I). This questionnaire assesses binge eating frequency over the past 28 days.
Measured: The change in binge eating frequency between baseline and day 16.
Quality of life
Health Status Scale Short-form 36 (SF-36)
Measured: The change in the SF-36 score between baseline and day 15.
Quality of life
Health Status Scale Short-form 36 (SF-36)
Measured: The change in the SF-36 score between baseline and day 16.
General mood
Positive Affect Negative Affect Schedule (PANAS).
Measured: The change in the overall score (positive affect minus negative affect) between baseline and day 15.
General mood
Positive Affect Negative Affect Schedule (PANAS).
Measured: The change in the overall score (positive affect minus negative affect) between baseline and day 16.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start15 Jan 2021 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AddictionStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roni Aviram-Friedman, PhD, Study director, Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692909
- Sponsor's protocol ID
- SOR032415CTIL
- Acronym
- FAOB-mPFC
- Status last verified
- Sep 2020
- First submitted
- 24 Sep 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Transcranial Magnetic Stimulation (dTMS) of the Medial Prefrontal Cortex (mPFC) in Food Addiction and Obesity
- ClinicalTrials.gov ID
- NCT04692909
- Acronym / sponsor ID
- FAOB-mPFC / SOR032415CTIL
- Conditions
- Food Addiction, Obesity, Morbid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- 15 Jan 2021 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 5 Jan 2021 (actual)
- 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.
This experiment is based on a unique technique of deep Transcranial magnetic stimulation (dTMS) of the brain's cortex, aiming to produce weight loss in food-addicted severely obese adults.
Detailed description
The neurobiological underpinnings of food addiction in obesity point to chemical, structural and functional imbalance in the mesolimbic dopaminergic brain system. This may cause symptoms of altered reward processing, excessive cravings for hyperpalatable food and repeated self-regulation failures to control food intake in this population. Specifically, the medial prefrontal cortex (mPFC), anterior cingulate cortex (ACC) and deeper reward-related brain regions function differentially from healthy controls and similarly to individuals with substance or behavioral addiction. Deep transcranial magnetic stimulation of the mPFC has been shown efficacious in reducing cravings and other addictive symptoms in individuals with SUD, as well as symptoms of compulsivity in obsessive compulsive disorder (OCD). In this study the investigators use deep transcranial magnetic stimulation (dTMS) with an H-coil to safely stimulate the mPFC and deeper brain regions, in individuals with obesity and food addiction. The investigators aim to produce neuroplasticity favoring the restoration of mPFC functioning, alleviating food addiction symptoms and promoting weight loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: dTMS with mPFC stimulationActive dTMS |
| Placebo | Placebo comparator | Device: dTMS with mPFC stimulationPlacebo dTMS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 30 ≤ BMI ≥ 50.
- Having had at least one prior conventional weight loss attempt, but no current weight loss attempts or over the last 3 months.
- Having satisfied a safety screening questionnaire for TMS (Keel, 2001)
- Omnivorous
- Have not had experience with TMS of any kind
Key exclusion criteria (25 listed)
- They experience tremor in any limb.
- They experience seizures.
- They have a history of epilepsy or seizure (EXCEPT those therapeutically induced by ECT, or febrile childhood seizures).
- They are at increased risk for seizures for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or a history of significant head trauma with loss of consciousness for > 5 minutes.
- A history of clinically significant neurological disorders, including organic brain disease, epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery or personal history of head trauma that resulted in loss of consciousness for > 5 minutes and retrograde amnesia for > 30 minutes (self-reported history).
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 |
|---|---|---|
| dTMS with mPFC stimulationdTMS with Brainsway's H7 device, stimulating the mPFC. | Device | Active, Placebo |
Primary outcome
Change in BMI
Time frame: Change in BMI between baseline and the end of the treatment (day 15) and follow-up (a month after day 15)
Unit of measure: BMI in kg/m^2 (weight in kilograms, height in meters)
Change in BMI
Time frame: Change in BMI between baseline and follow-up (a month after day 15)
Unit of measure: BMI in kg/m^2 (weight in kilograms, height in meters)
16 secondary outcomes
Change in food addiction symptoms on the Yale Food Addiction Scale (YFAS)
Time frame: The change in the number of symptoms on day 15 compared to baseline will be assessed.
Change in food addiction symptoms on the Yale Food Addiction Scale (YFAS)
Time frame: The change in the number of symptoms on day 16 (a month after day 15) compared to baseline will be assessed.
Cognitive regulation of eating
Time frame: The change in reaction time on the Food Stroop task between day 15 and baseline.
Cognitive regulation of eating
Time frame: The change in reaction time on the Food Stroop task between day 16 (a month after day 15) and baseline.
Depressive symptoms
Time frame: A change in BDI score from baseline to day 15.
Depressive symptoms
Time frame: A change in BDI score from baseline to day 16.
Eating behavior [cognitive restraint (CR), emotional eating (EE), uncontrollable eating (UE)] will be assessed with the Three Factor Eating Questionnaire (TFEQ).
Time frame: The change in these parameters will be assessed between baseline and day 15.
Eating behavior [cognitive restraint (CR), emotional eating (EE), uncontrollable eating (UE)] will be assessed with the Three Factor Eating Questionnaire (TFEQ).
Time frame: The change in these parameters will be assessed between day 16 (a month after day 15) and baseline.
Eating behavior [restrictive eating (RE), emotional eating (EME), external eating (EXE)] will be assessed with the Dutch Eating Behavior Questionnaire (DEBQ)
Time frame: The change in these parameters will be assessed between baseline and day 15.
Eating behavior [restrictive eating (RE), emotional eating (EME), external eating (EXE)]
Time frame: The change in these parameters will be assessed between day 16 (a month after day 15) and baseline.
Binge eating frequency
Time frame: The change in binge eating frequency between baseline and day 15.
Binge eating frequency
Time frame: The change in binge eating frequency between baseline and day 16.
Quality of life
Time frame: The change in the SF-36 score between baseline and day 15.
Quality of life
Time frame: The change in the SF-36 score between baseline and day 16.
General mood
Time frame: The change in the overall score (positive affect minus negative affect) between baseline and day 15.
General mood
Time frame: The change in the overall score (positive affect minus negative affect) between baseline and day 16.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
Roni Aviram-Friedman, PhD study director
Ben-Gurion University of the Negev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dTMS with mPFC stimulation in people with Food Addiction and Obesity, Morbid, run by Soroka University Medical Center at 1 site in Israel.
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 5 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 5 Jan 2021. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abraham Zangen, PhD (97286472646, azangen@bgu.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BMI (time frame: Change in BMI between baseline and the end of the treatment (day 15) and follow-up (a month after day 15)). The study lists 2 primary outcomes in all. 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 5 Jan 2021.