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

Obesity Clinical Trial

— FAOB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02761369
• Other study ID #: SOR-0324-15-CTIL
• Status: Recruiting
• Phase: N/A
• First received: April 20, 2016
• Last updated: January 2, 2018
• Start date: June 18, 2017
• Est. completion date: June 2018

Study information

• Verified date: June 2017
• Source: Soroka University Medical Center
• Contact: Roni Aviram-Friedman, PhD
• Phone: 19292245107
• Email: aviramro[@]bgu.post.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Addictive
• Obesity

Intervention

Device:
• A multi-channel deep TMS device with an H-coil (Brainsway Ltd)
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.

Locations

Country	Name	City	State
Israel	SorokaUMC	Beer Sheva

Sponsors (2)

Lead Sponsor	Collaborator
Soroka University Medical Center	Ben-Gurion University of the Negev

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	General mood	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)
Primary	Change in weight	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	Performance on a food Stroop test	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)
Secondary	Food addiction symptoms	Yale Food Addiction Scale (YFAS)	Change between baseline versus the end of the treatment (day 15) and follow-up (a month after day 15)
Secondary	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	Throughout the study period, estimated as 2 years
Secondary	Eating behavior (cognitive restraint, disinhibition, and hunger)	Three Factor Eating Questionnaire (TFEQ)	Change between baseline versus the end of the treatment (day 15) and follow-up (a month after day 15)
Secondary	Quality of life	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)
Secondary	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)	Changes in cortical excitability between baseline versus following 15 days of treatment