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ObesityNCT03650309

Deep Brain Stimulation for Morbid Obesity

A study testing Deep Brain Stimulation in people with Obesity and Obesity, Morbid, run by University Health Network, Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label, phase I pilot trial designed to evaluate the safety and feasibility of deep brain stimulation (DBS) for the treatment of refractory morbid obesity. Patients with diagnoses of morbid obesity will be recruited and enrolled. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Obesity, Obesity, Morbid
What is being tested?
Deep Brain Stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteCanada
Study dates
1 Sep 2018to 23 Jul 2022
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 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female or Male patients between age 20-60
  • Diagnosis of Morbid Obesity (defined as a BMI>40kg/m2 or BMI>35 with 1 obesity related comorbidity) OR a diagnosis of Binge Eating Disorder not responsive to recommended treatments (as defined by the DSM-5)
  • Failure or non eligibility of bariatric surgery with <50% of excess weight loss, with or without BMI>35 kg/m2, at 18 months or more after the operation; OR diagnosis of binge eating disorder for over 18 months
  • Diagnosis of food dependence via Yale Food Addiction Scale (YFAS) criteria
  • Normal neurological exam
  • Normal head CT scan and cerebral MRI
  • Patient informed and able to give written consent
  • Able to comply with all testing, follow-ups and study appointments and protocols

Who cannot join

  • Active neurologic disease such as epilepsy
  • Alcohol or substance dependence or abuse in the last 6 months, excluding caffeine and nicotine
  • Any contraindication to magnetic resonance imaging (MRI) or positron emission tomography (PET) scanning
  • Likely to relocate or move during the study's one year duration
  • Presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions as a result of morbid obesity, that will result in significant risk from a surgical procedure.
  • Presence of epilepsy, stroke or degenerative disorder of the nervous system
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Toronto Western Hospital, University Health Network

    Toronto, Ontario, M5T 2S8

Other trials in Canada

About this study

Official title: Deep Brain Stimulation for the Treatment of Refractory Morbid Obesity

This is an open-label, phase I pilot trial designed to evaluate the safety and feasibility of deep brain stimulation (DBS) for the treatment of refractory morbid obesity. Patients with diagnoses of morbid obesity will be recruited and enrolled. All patients will receive DBS targeting two brains areas involved in the pathophysiology of obesity and will be followed post-operatively for 12 months.

Read the detailed description

This study will establish 1)the safety of deep brain stimulation (DBS) in a patient population with treatment refractory morbid obesity. DBS has been used safely and effectively in thousands of patients for numerous disorders. Recent evidence (outlined above) has shown that DBS can also be used to manage refractory psychiatric conditions, such as depression and obsessive-compulsive disorder, as well as in eating disorders such as anorexia nervosa. Such studies indicate that a targeted therapy informed by the neuroanatomic and circuitry literature can be effective in altering pathological mood and behaviour. 2) evaluate the effectiveness of the procedure, which will be evaluated by the actual weight loss and resolution of the core symptoms of morbid obesity, including BMI, as well of, depression, self-esteem, and binge eating scores surrounding with loss or weight gain.

Being tested
Deep Brain Stimulation
Keywords
Deep Brain Stimulation, Functional Neurosurgery, Neuromodulation, Bariatrics, Weight Loss, Addiction
Medical subject headings
Obesity, Obesity, Morbid, Weight Loss, Behavior, Addictive

What participants receive

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

  • Deep Brain StimulationDevice

    All patients will undergo surgical implantation of a deep brain stimulation (DBS) system, which involves placement of stimulating electrodes in the brain. These electrodes will be used to deliver electrical current to target two brain structures involved in the pathophysiology of obesity.

Study groups in NCT03650309
Study groupRoleWhat they receive
Deep Brain StimulationExperimentalAll patients will receive deep brain stimulation (DBS) targeting two brain areas involved in the pathophysiology of obesity. No other changes to pre-existing treatment will be made. This is the only arm in this experiment.
Receives: Device: Deep Brain Stimulation

What is being measured

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

  1. Incidence of Treatment-Emergent Adverse Events

    Patients will be closely monitored for adverse events following DBS surgery with regular check-ups.

    Measured: 12 months

Secondary outcomes (13)

  1. Weight

    Weight (in kilograms) will be frequently assessed prior to and following DBS surgery.

    Measured: 12 months

  2. 'Quality of Life Scale' Questionnaire

    Patients will regularly complete the 16-item Quality of Life Scale questionnaire (worst score = 16, best score = 112) to assess psychosocial function.

    Measured: 12 months

  3. 'Behavioral Inhibition System/Behavioral Activation System Scales (BIS/BAS Scales)' Questionnaire

    Patients will regularly complete the 24-item BIS/BAS Scales questionnaire to assess psychosocial behaviour. This questionnaire has 3 sub-scales: 'BAS drive' (highest score = 16, lowest score = 4), 'BAS fun seeking' (highest score = 20, lowest score = 5), 'BAS reward responsiveness' (highest score = 20, lowest score = 5), and 'BIS' (highest score = 28, lowest score = 7).

    Measured: 12 months

  4. 'Patient Health Questionnaire (PHQ-9)' Questionnaire

    Patients will regularly complete the 9-item PHQ-9 questionnaire (worst score = 27, best score = 0) to assess mood and depression symptoms.

    Measured: 12 months

  5. 'Generalized Anxiety Disorder 7-item (GAD-7)' Questionnaire

    Patients will regularly complete the 7-item GAD-7 questionnaire (worst score = 21, best score = 0) to assess anxiety symptoms.

    Measured: 12 months

  6. 'Difficulties in Emotion Regulation Scale (DERS)' Questionnaire

    Patients will regularly complete the 36-item DERS questionnaire (worst score = 180, best score = 36) to assess emotional dysregulation.

    Measured: 12 months

  7. 'Yale-Brown Obsessive Compulsive Scale (Y-BOCS)' Questionnaire

    Patients will regularly complete the 10-item Y-BOCS questionnaire (worst score = 40, best score = 0) to assess severity of obsessive and compulsive symptoms

    Measured: 12 months

  8. 'Binge Eating Scale (BES)' Questionnaire

    Patients will regularly complete the 16-item BES questionnaire (worst score = 43, best score = 0) to assess binge eating symptoms

    Measured: 12 months

  9. 'Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS)' Questionnaire

    Patients will regularly complete the 19-item YBC-EDS questionnaire (worst score = 32, best score = 0) to assess eating-related preoccupations and rituals

    Measured: 12 months

  10. 'Emotional Eating Scale (EES)' Questionnaire

    Patients will regularly complete the 25-item EES questionnaire (worst score = 100, best score = 0) to assess their emotional relationship with food.

    Measured: 12 months

  11. 'Power of Food (POF)' Questionnaire

    Patients will regularly complete the 15-item POF questionnaire (worst score = 75, best score = 15) to assess the degree of influence food exerts on their day-to-day life.

    Measured: 12 months

  12. 'Eating Disorder Examination Questionnaire (EDE-Q)'

    Patients will regularly complete the 28-item EDE-Q (worst score = 6, best score = 0) to assess aspects of eating behaviour including restraint, eating concern, shape concern, and weight concern.

    Measured: 12 months

  13. 'Yale Food Addiction Scale (YFAS)' Questionnaire

    Patients will regularly complete the 25-item YFAS (higher numbers = more severe symptoms) to assess the severity of food addiction.

    Measured: 12 months

Timeline

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

  1. First posted28 Aug 2018
  2. Study start1 Sep 2018
  3. Primary completion23 Jan 2022
  4. Study completion23 Jul 2022

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03650309
Sponsor's protocol ID
17-5899
Status last verified
May 2024
First submitted
10 Aug 2018
Last updated
8 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Deep Brain Stimulation in people with Obesity and Obesity, Morbid, run by University Health Network, Toronto at 1 site in Canada.

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 8 inclusion and 7 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: finished, as of the sponsor's last update on 8 May 2024. 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 Canada. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (time frame: 12 months). 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 NCT03650309.

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 8 May 2024.

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Deep Brain Stimulation for Morbid Obesity | AzTrials