- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02761369
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
Status
Unknown
Conditions
Intervention / Treatment
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
- Name: Roni Aviram-Friedman, PhD
- Phone Number: 19292245107
- Email: aviramro@bgu.post.ac.il
Study Locations
-
-
-
Beer Sheva, Israel, 84101
- Recruiting
- SorokaUMC
-
Contact:
- Roni Aviram-Friedman
- Phone Number: 19292245107
- Email: aviramro@post.bgu.ac.il
-
-
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.
Sponsor
Collaborators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- SOR-0324-15-CTIL
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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