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ObesityFAOBNCT02761369

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

A study testing A multi-channel deep TMS device with an H-coil (Brainsway Ltd) in people with Obesity, run by Soroka University Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 22 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
A multi-channel deep TMS device with an H-coil (Brainsway Ltd)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteIsrael
Study dates
18 Jun 2017to Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).
Show all 28Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Roni Aviram-Friedman, PhD contact

19292245107

aviramro@bgu.post.ac.il

Israel1 site, 1 recruiting

  • SorokaUMC

    Beersheba, 84101

    Roni Aviram-Friedman, 19292245107, aviramro@post.bgu.ac.il

    Recruiting

Other trials in Israel

About this study

Official title: 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.

Conditions
Obesity
Being tested
A multi-channel deep TMS device with an H-coil (Brainsway Ltd)
Keywords
food addiction, obesity, deep TMS, PAS, Food Stroop, brain laterality, EEG, INP
Medical subject headings
Obesity, Food Addiction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT02761369
Study groupRoleWhat they receive
A PAS protocol, right-to-left, via deep TMSExperimentalVia a multi-channel deep TMS device with an H-coil (Brainsway Ltd), a PAS protocol, starting with the right DLPFC
Receives: Device: A multi-channel deep TMS device with an H-coil (Brainsway Ltd)
A PAS protocol, left-to-right, via deep TMSExperimentalVia a multi-channel deep TMS device with an H-coil (Brainsway Ltd), a PAS protocol, starting with the left DLPFC
Receives: Device: A multi-channel deep TMS device with an H-coil (Brainsway Ltd)
A sham PAS protocol, via deep TMSSham comparatorVia 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)
Receives: Device: A multi-channel deep TMS device with an H-coil (Brainsway Ltd)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in weight

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

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

Secondary outcomes (6)

  1. Performance on a food Stroop test

    Unit of measure: reaction time (in milliseconds)

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

  2. Food addiction symptoms

    Yale Food Addiction Scale (YFAS)

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

  3. 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

    Measured: Throughout the study period, estimated as 2 years

  4. Eating behavior (cognitive restraint, disinhibition, and hunger)

    Three Factor Eating Questionnaire (TFEQ)

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

  5. Quality of life

    Health Status Scale Short-form 36 (SF-36)

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

  6. 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)

    Measured: Changes in cortical excitability between baseline versus following 15 days of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2016 (estimated)
  2. Study start18 Jun 2017
  3. Primary completionJun 2018 (estimated)
  4. Study completionJun 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02761369
Sponsor's protocol ID
SOR-0324-15-CTIL
Acronym
FAOB
Status last verified
Jun 2017
First submitted
20 Apr 2016
Last updated
3 Jan 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing A multi-channel deep TMS device with an H-coil (Brainsway Ltd) in people with Obesity, run by Soroka University Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Roni Aviram-Friedman, PhD (19292245107, aviramro@bgu.post.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02761369.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2018.

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