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

NCT04692909 | Unknown DMC

• 1 other identifier: SOR032415CTIL
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Food Addiction; Obesity, Morbid

Outcome Measures

Primary Outcomes (2)

• Change in BMI

  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

  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 Outcomes (16)

• Change in food addiction symptoms on the Yale Food Addiction Scale (YFAS)

  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 change in the number of symptoms on day 16 (a month after day 15) compared to baseline will be assessed.

• Cognitive regulation of eating

  The change in reaction time on the Food Stroop task between day 15 and baseline.

• Cognitive regulation of eating

  The change in reaction time on the Food Stroop task between day 16 (a month after day 15) and baseline.

• Depressive symptoms

  A change in BDI score from baseline to day 15.

Study Arms (2)

Active

ACTIVE COMPARATOR

Active dTMS

Device: dTMS with mPFC stimulation

Placebo

PLACEBO COMPARATOR

Placebo dTMS

Device: dTMS with mPFC stimulation

Interventions

dTMS with mPFC stimulation DEVICE

dTMS with Brainsway's H7 device, stimulating the mPFC.

Active; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ 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

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Soroka University Medical Center: lead

Study Sites (1)

Soroka University Medical Center

Beersheba, Israel

RECRUITING

MeSH Terms

Conditions

Food Addiction; Obesity, Morbid

Condition Hierarchy (Ancestors)

Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Behavior; Feeding and Eating Disorders; Mental Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Roni Aviram-Friedman, PhD

  Ben-Gurion University of the Negev

  STUDY DIRECTOR

Central Study Contacts

Abraham Zangen, PhD

CONTACT

97286472646; azangen@bgu.ac.il

Shahar Atias, MD

CONTACT

972544783129; atiassh@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: January 5, 2021
• Study Start: January 15, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 5, 2021

Record last verified: 2020-09

Locations

IL (1)