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

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
A multi-channel deep TMS device with an H-coil (Brainsway Ltd)
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring food addiction, obesity, deep TMS, PAS, Food Stroop, brain laterality, EEG, INP

Eligibility Criteria

22 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • SorokaUMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

A PAS protocol, right-to-left, via deep TMS

A PAS protocol, left-to-right, via deep TMS

A sham PAS protocol, via deep TMS

Arm Description

Via a multi-channel deep TMS device with an H-coil (Brainsway Ltd), a PAS protocol, starting with the right DLPFC

Via a multi-channel deep TMS device with an H-coil (Brainsway Ltd), a PAS protocol, starting with the left DLPFC

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)

Outcomes

Primary Outcome Measures

Change in weight
Unit of measure: BMI in kg/m^2 (weight in kilograms, height in meters)

Secondary Outcome Measures

Performance on a food Stroop test
Unit of measure: reaction time (in milliseconds)
Food addiction symptoms
Yale Food Addiction Scale (YFAS)
Safety and tolerability of a PAS protocol using the multi-channel deep TMS system, measured via the number of adverse events (AE)
Measured via the number of adverse events
Eating behavior (cognitive restraint, disinhibition, and hunger)
Three Factor Eating Questionnaire (TFEQ)
Quality of life
Health Status Scale Short-form 36 (SF-36)
Implementation of INP
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)

Full Information

First Posted
April 20, 2016
Last Updated
January 2, 2018
Sponsor
Soroka University Medical Center
Collaborators
Ben-Gurion University of the Negev
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1. Study Identification

Unique Protocol Identification Number
NCT02761369
Brief Title
Deep Transcranial Magnetic Stimulation (TMS) With Paired Associative Stimulation (PAS) for the Treatment of Food Addiction in Obesity
Acronym
FAOB
Official Title
Comparison of Two Deep TMS Protocols With Paired Associative Stimulation (PAS) for the Treatment of Food Addiction in Severe Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 18, 2017 (Actual)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soroka University Medical Center
Collaborators
Ben-Gurion University of the Negev

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
food addiction, obesity, deep TMS, PAS, Food Stroop, brain laterality, EEG, INP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A PAS protocol, right-to-left, via deep TMS
Arm Type
Experimental
Arm Description
Via a multi-channel deep TMS device with an H-coil (Brainsway Ltd), a PAS protocol, starting with the right DLPFC
Arm Title
A PAS protocol, left-to-right, via deep TMS
Arm Type
Experimental
Arm Description
Via a multi-channel deep TMS device with an H-coil (Brainsway Ltd), a PAS protocol, starting with the left DLPFC
Arm Title
A sham PAS protocol, via deep TMS
Arm Type
Sham Comparator
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
A multi-channel deep TMS device with an H-coil (Brainsway Ltd)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in weight
Description
Unit of measure: BMI in kg/m^2 (weight in kilograms, height in meters)
Time Frame
Change in weight between baseline versus the end of the treatment (day 15) and follow-up (a month after day 15)
Secondary Outcome Measure Information:
Title
Performance on a food Stroop test
Description
Unit of measure: reaction time (in milliseconds)
Time Frame
Change in performance between baseline versus the end of the treatment (day 15) and follow-up (a month after day 15)
Title
Food addiction symptoms
Description
Yale Food Addiction Scale (YFAS)
Time Frame
Change between baseline versus the end of the treatment (day 15) and follow-up (a month after day 15)
Title
Safety and tolerability of a PAS protocol using the multi-channel deep TMS system, measured via the number of adverse events (AE)
Description
Measured via the number of adverse events
Time Frame
Throughout the study period, estimated as 2 years
Title
Eating behavior (cognitive restraint, disinhibition, and hunger)
Description
Three Factor Eating Questionnaire (TFEQ)
Time Frame
Change between baseline versus the end of the treatment (day 15) and follow-up (a month after day 15)
Title
Quality of life
Description
Health Status Scale Short-form 36 (SF-36)
Time Frame
Change between baseline and the end of the treatment (day 15) and follow-up (a month after day 15)
Title
Implementation of INP
Description
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)
Time Frame
Changes in cortical excitability between baseline versus following 15 days of treatment
Other Pre-specified Outcome Measures:
Title
General mood
Description
Positive Affect Negative Affect Schedule (PANAS)
Time Frame
Change between baseline versus the end of the treatment (day 15) and follow-up (a month after day 15)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roni Aviram-Friedman, PhD
Phone
19292245107
Email
aviramro@bgu.post.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eliezer Avinoach, MD
Organizational Affiliation
Soroka UMC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roni Aviram-Friedman, PhD
Organizational Affiliation
Ben-Gurion University of the Negev
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Abraham Zangen, PhD
Organizational Affiliation
Ben-Gurion University of the Negev
Official's Role
Study Chair
Facility Information:
Facility Name
SorokaUMC
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roni Aviram-Friedman
Phone
19292245107
Email
aviramro@post.bgu.ac.il

12. IPD Sharing Statement

Learn more about this trial

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

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