Deep Transcranial Magnetic Stimulation (dTMS) of the Medial Prefrontal Cortex in Food Addiction and Obesity (FAOB-mPFC)

December 31, 2020 updated by: Soroka University Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Israel
      • Beer Sheva, Israel
        • Recruiting
        • Soroka university medical center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • Exclusion Criteria:
  • 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.

Exclusion criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Active
Active dTMS
Device: dTMS with mPFC stimulation
dTMS with Brainsway's H7 device, stimulating the mPFC.
Placebo Comparator: Placebo
Placebo dTMS
Device: dTMS with mPFC stimulation
dTMS with Brainsway's H7 device, stimulating the mPFC.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 between baseline and the end of the treatment (day 15) and follow-up (a month after day 15)
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)
Change in BMI between baseline and follow-up (a month after day 15)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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 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.
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.
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.
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 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.
A change in BDI score from baseline to day 15.
Depressive symptoms
Time Frame: A change in BDI score from baseline to day 16.
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.
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.
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.
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.
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.
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.
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.
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.
The DEBQ measures RE, EME and EXE, A change (decrease or increase) in the
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 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.
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.
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.
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.
Health Status Scale Short-form 36 (SF-36)
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.
Health Status Scale Short-form 36 (SF-36)
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.
Positive Affect Negative Affect Schedule (PANAS).
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.
Positive Affect Negative Affect Schedule (PANAS).
The change in the overall score (positive affect minus negative affect) between baseline and day 16.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Soroka University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SOR032415CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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