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

NCT02761369 | Unknown DMC

• 1 other identifier: SOR-0324-15-CTIL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

food addiction; obesity; deep TMS; PAS; Food Stroop; brain laterality; EEG; INP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Performance on a food Stroop test

  Change in performance between baseline versus the end of the treatment (day 15) and follow-up (a month after day 15)

• Food addiction symptoms

  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)

  Throughout the study period, estimated as 2 years

• Eating behavior (cognitive restraint, disinhibition, and hunger)

  Change between baseline versus the end of the treatment (day 15) and follow-up (a month after day 15)

• Quality of life

  Change between baseline and the end of the treatment (day 15) and follow-up (a month after day 15)

Other Outcomes (1)

• General mood

  Change between baseline versus the end of the treatment (day 15) and follow-up (a month after day 15)

Study Arms (3)

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

A sham PAS protocol, via deep TMS

SHAM COMPARATOR

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)

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

Interventions

A multi-channel deep TMS device with an H-coil (Brainsway Ltd) DEVICE

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.

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

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Soroka University Medical Center: lead
• Ben-Gurion University of the Negev: collaborator

Study Sites (1)

SorokaUMC

Beersheba, 84101, Israel

RECRUITING

MeSH Terms

Conditions

Obesity; Food Addiction

Condition Hierarchy (Ancestors)

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

Study Officials

• Eliezer Avinoach, MD

  Soroka UMC

  PRINCIPAL INVESTIGATOR

• Roni Aviram-Friedman, PhD

  Ben-Gurion University of the Negev

  STUDY DIRECTOR

• Abraham Zangen, PhD

  Ben-Gurion University of the Negev

  STUDY CHAIR

Central Study Contacts

Roni Aviram-Friedman, PhD

CONTACT

19292245107; aviramro@bgu.post.ac.il

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: April 20, 2016
• First Posted: May 4, 2016
• Study Start: June 18, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: January 3, 2018

Record last verified: 2017-06

Locations

IL (1)