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Deep Brain Stimulation for Morbid Obesity

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ClinicalTrials.gov Identifier: NCT03650309
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Andres M. Lozano, University Health Network, Toronto

Brief 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. All patients will receive DBS targeting two brains areas involved in the pathophysiology of obesity and will be followed post-operatively for 12 months.

Condition or disease Intervention/treatment Phase
Obesity Obesity, Morbid Device: Deep Brain Stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation for the Treatment of Refractory Morbid Obesity
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : January 23, 2021
Estimated Study Completion Date : July 23, 2021

Arm Intervention/treatment
Experimental: Deep Brain Stimulation
All 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.
Device: Deep Brain Stimulation
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.




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 12 months ]
    Patients will be closely monitored for adverse events following DBS surgery with regular check-ups.


Secondary Outcome Measures :
  1. Weight [ Time Frame: 12 months ]
    Weight (in kilograms) will be frequently assessed prior to and following DBS surgery.

  2. 'Quality of Life Scale' Questionnaire [ Time Frame: 12 months ]
    Patients will regularly complete the 16-item Quality of Life Scale questionnaire (worst score = 16, best score = 112) to assess psychosocial function.

  3. 'Behavioral Inhibition System/Behavioral Activation System Scales (BIS/BAS Scales)' Questionnaire [ Time Frame: 12 months ]
    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).

  4. 'Patient Health Questionnaire (PHQ-9)' Questionnaire [ Time Frame: 12 months ]
    Patients will regularly complete the 9-item PHQ-9 questionnaire (worst score = 27, best score = 0) to assess mood and depression symptoms.

  5. 'Generalized Anxiety Disorder 7-item (GAD-7)' Questionnaire [ Time Frame: 12 months ]
    Patients will regularly complete the 7-item GAD-7 questionnaire (worst score = 21, best score = 0) to assess anxiety symptoms.

  6. 'Difficulties in Emotion Regulation Scale (DERS)' Questionnaire [ Time Frame: 12 months ]
    Patients will regularly complete the 36-item DERS questionnaire (worst score = 180, best score = 36) to assess emotional dysregulation.

  7. 'Yale-Brown Obsessive Compulsive Scale (Y-BOCS)' Questionnaire [ Time Frame: 12 months ]
    Patients will regularly complete the 10-item Y-BOCS questionnaire (worst score = 40, best score = 0) to assess severity of obsessive and compulsive symptoms

  8. 'Binge Eating Scale (BES)' Questionnaire [ Time Frame: 12 months ]
    Patients will regularly complete the 16-item BES questionnaire (worst score = 43, best score = 0) to assess binge eating symptoms

  9. 'Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS)' Questionnaire [ Time Frame: 12 months ]
    Patients will regularly complete the 19-item YBC-EDS questionnaire (worst score = 32, best score = 0) to assess eating-related preoccupations and rituals

  10. 'Emotional Eating Scale (EES)' Questionnaire [ Time Frame: 12 months ]
    Patients will regularly complete the 25-item EES questionnaire (worst score = 100, best score = 0) to assess their emotional relationship with food.

  11. 'Power of Food (POF)' Questionnaire [ Time Frame: 12 months ]
    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.

  12. 'Eating Disorder Examination Questionnaire (EDE-Q)' [ Time Frame: 12 months ]
    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.

  13. 'Yale Food Addiction Scale (YFAS)' Questionnaire [ Time Frame: 12 months ]
    Patients will regularly complete the 25-item YFAS (higher numbers = more severe symptoms) to assess the severity of food addiction.



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female or Male patients between age 20-60
  2. 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)
  3. 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
  4. Diagnosis of food dependence via Yale Food Addiction Scale (YFAS) criteria
  5. Normal neurological exam
  6. Normal head CT scan and cerebral MRI
  7. Patient informed and able to give written consent
  8. Able to comply with all testing, follow-ups and study appointments and protocols

Exclusion Criteria:

  1. Active neurologic disease such as epilepsy
  2. Alcohol or substance dependence or abuse in the last 6 months, excluding caffeine and nicotine
  3. Any contraindication to magnetic resonance imaging (MRI) or positron emission tomography (PET) scanning
  4. Likely to relocate or move during the study's one year duration
  5. 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.
  6. Presence of epilepsy, stroke or degenerative disorder of the nervous system
  7. Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03650309


Contacts
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Contact: Gavin Elias 4166035800 ext 6200 gavin.elias@uhnresearch.ca
Contact: Maheleth Llinas 4166035800 ext 3304

Locations
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Canada, Ontario
Toronto Western Hospital, University Health Network Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Gavin Elias         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Andres Lozano University Health Network, Toronto

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Responsible Party: Andres M. Lozano, Neurosurgeon, Professor of Surgery, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03650309     History of Changes
Other Study ID Numbers: 17-5899
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Andres M. Lozano, University Health Network, Toronto:
Deep Brain Stimulation
Functional Neurosurgery
Neuromodulation
Bariatrics
Weight Loss
Addiction
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms