Deep Transcranial Magnetic Stimulation (TMS) With Paired Associative Stimulation (PAS) for the Treatment of Food Addiction in Obesity (FAOB)

January 2, 2018 updated by: Soroka University Medical Center

Comparison of Two Deep TMS Protocols With Paired Associative Stimulation (PAS) for the Treatment of Food Addiction in Severe Obesity

The neurobiological underpinnings of obesity point to brain asymmetry in cortical and deeper brain regions. Furthermore, chemical, structural and functional imbalance in cortical and sub-cortical brain regions alters reward processing, attentional control and self-regulation in food-addicted obese individuals. In this study the investigators use TMS with a special multichannel H-coil developed by their lab to safely stimulate cortical and deeper brain regions in obese humans. The investigators aim to produce interhemispheric neuroplasticity (INP) using a paired associative stimulation (PAS) protocol over the DLPFC, to restore neurobiological functioning, alleviate food addiction symptoms, and promote weight loss.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • 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 Locations

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

Ages Eligible for Study

22 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 30 ≤ BMI ≥ 40.
  • 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:

  • The participant experiences tremor in any limb.
  • The participant experiences seizures.
  • The participant has a history of epilepsy or seizure (EXCEPT those therapeutically induced by ECT), or a history of such in first degree relatives.
  • The participant is 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.
  • The participant has a history of head injury.
  • The participant suffers from an unstable physical disease, such as high blood pressure (>150 mmHg systolic / diastolic > 110 mmHg) or acute, unstable cardiac disease The participant is at a high risk for severe violence or suicidal tendencies, assessed during the screening interview (see appendix 4).
  • 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 suffers from a significant neurological disorder or insult including, but not limited to:

    • Any condition likely to be associated with increased intracranial pressure
    • Space occupying brain lesion
    • History of cerebrovascular accident
    • Transient ischemic attack within the last two years
    • Cerebral aneurysm
    • Dementia
    • Parkinson's disease
    • Huntington's chorea
    • Multiple sclerosis
  • The participant has any cognitive or functional disability, according to criteria specified in the DSM-V, such as active psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-V; Axis I and Axis II) diagnosed within the last year.
  • The participant has started or changed a psychotropic prescription within the last three months.
  • The participant has current alcohol or other substance abuse or dependence, or has had one over the last 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 participant is a sexually-active woman of childbearing age, who does not use a medically accepted form of contraception.
  • 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.
  • 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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A PAS protocol, right-to-left, via deep TMS
Via a multi-channel deep TMS device with an H-coil (Brainsway Ltd), a PAS protocol, starting with the right DLPFC
A 3-week long treatment (15 days). Treatment session consist of 300 rapidly occurring pairs of pulses over the dorsolateral prefrontal cortex (at a frequency of 10 Hz and intensity of 110% of individual's motor threshold), with a 5-seconds interval, for a duration of 1800 seconds in total.
EXPERIMENTAL: A PAS protocol, left-to-right, via deep TMS
Via a multi-channel deep TMS device with an H-coil (Brainsway Ltd), a PAS protocol, starting with the left DLPFC
A 3-week long treatment (15 days). Treatment session consist of 300 rapidly occurring pairs of pulses over the dorsolateral prefrontal cortex (at a frequency of 10 Hz and intensity of 110% of individual's motor threshold), with a 5-seconds interval, for a duration of 1800 seconds in total.
SHAM_COMPARATOR: A sham PAS protocol, via deep TMS
Via a multi-channel deep TMS device with an H-coil (Brainsway Ltd), a sham PAS protocol, starting with the right DLPFC (@ 40% of individual MT)
A 3-week long treatment (15 days). Treatment session consist of 300 rapidly occurring pairs of pulses over the dorsolateral prefrontal cortex (at a frequency of 10 Hz and intensity of 110% of individual's motor threshold), with a 5-seconds interval, for a duration of 1800 seconds in total.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in weight
Time Frame: Change in weight between baseline versus 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 weight between baseline versus the end of the treatment (day 15) and follow-up (a month after day 15)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance on a food Stroop test
Time Frame: Change in performance between baseline versus the end of the treatment (day 15) and follow-up (a month after day 15)
Unit of measure: reaction time (in milliseconds)
Change in performance between baseline versus the end of the treatment (day 15) and follow-up (a month after day 15)
Food addiction symptoms
Time Frame: Change between baseline versus the end of the treatment (day 15) and follow-up (a month after day 15)
Yale Food Addiction Scale (YFAS)
Change between baseline versus the end of the treatment (day 15) and follow-up (a month after day 15)
Safety and tolerability of a PAS protocol using the multi-channel deep TMS system, measured via the number of adverse events (AE)
Time Frame: Throughout the study period, estimated as 2 years
Measured via the number of adverse events
Throughout the study period, estimated as 2 years
Eating behavior (cognitive restraint, disinhibition, and hunger)
Time Frame: Change between baseline versus the end of the treatment (day 15) and follow-up (a month after day 15)
Three Factor Eating Questionnaire (TFEQ)
Change between baseline versus the end of the treatment (day 15) and follow-up (a month after day 15)
Quality of life
Time Frame: Change between baseline and the end of the treatment (day 15) and follow-up (a month after day 15)
Health Status Scale Short-form 36 (SF-36)
Change between baseline and the end of the treatment (day 15) and follow-up (a month after day 15)
Implementation of INP
Time Frame: Changes in cortical excitability between baseline versus following 15 days of treatment
1. Acute change in INP, assessed via changes in cortical excitability (measured via EEG and TCI) between pre- and post PAS administration. 2. Chronic change in INP assessed as change in cortical excitability between baseline versus the end of the treatment (day 15) and follow up (measured via EEG and TCI)
Changes in cortical excitability between baseline versus following 15 days of treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
General mood
Time Frame: Change between baseline versus the end of the treatment (day 15) and follow-up (a month after day 15)
Positive Affect Negative Affect Schedule (PANAS)
Change between baseline versus the end of the treatment (day 15) and follow-up (a month after day 15)

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Eliezer Avinoach, MD, Soroka UMC
  • Study Chair: Abraham Zangen, PhD, Ben-Gurion University of the Negev

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 (ACTUAL)

June 18, 2017

Primary Completion (ANTICIPATED)

June 1, 2018

Study Completion (ANTICIPATED)

June 1, 2018

Study Registration Dates

First Submitted

April 20, 2016

First Submitted That Met QC Criteria

May 1, 2016

First Posted (ESTIMATE)

May 4, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 3, 2018

Last Update Submitted That Met QC Criteria

January 2, 2018

Last Verified

June 1, 2017

More Information

Terms related to this study

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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