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Deep Brain Stimulation for Morbid Obesity

Primary Purpose

Obesity, Obesity, Morbid

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Deep Brain Stimulation
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Deep Brain Stimulation, Functional Neurosurgery, Neuromodulation, Bariatrics, Weight Loss, Addiction

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Toronto Western Hospital, University Health NetworkRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Deep Brain Stimulation

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events
Patients will be closely monitored for adverse events following DBS surgery with regular check-ups.

Secondary Outcome Measures

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

Full Information

First Posted
August 10, 2018
Last Updated
May 16, 2022
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03650309
Brief Title
Deep Brain Stimulation for Morbid Obesity
Official Title
Deep Brain Stimulation for the Treatment of Refractory Morbid Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
January 23, 2023 (Anticipated)
Study Completion Date
July 23, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Obesity, Morbid
Keywords
Deep Brain Stimulation, Functional Neurosurgery, Neuromodulation, Bariatrics, Weight Loss, Addiction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Deep Brain Stimulation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Deep Brain Stimulation
Intervention Description
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 Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
Patients will be closely monitored for adverse events following DBS surgery with regular check-ups.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Weight
Description
Weight (in kilograms) will be frequently assessed prior to and following DBS surgery.
Time Frame
12 months
Title
'Quality of Life Scale' Questionnaire
Description
Patients will regularly complete the 16-item Quality of Life Scale questionnaire (worst score = 16, best score = 112) to assess psychosocial function.
Time Frame
12 months
Title
'Behavioral Inhibition System/Behavioral Activation System Scales (BIS/BAS Scales)' Questionnaire
Description
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).
Time Frame
12 months
Title
'Patient Health Questionnaire (PHQ-9)' Questionnaire
Description
Patients will regularly complete the 9-item PHQ-9 questionnaire (worst score = 27, best score = 0) to assess mood and depression symptoms.
Time Frame
12 months
Title
'Generalized Anxiety Disorder 7-item (GAD-7)' Questionnaire
Description
Patients will regularly complete the 7-item GAD-7 questionnaire (worst score = 21, best score = 0) to assess anxiety symptoms.
Time Frame
12 months
Title
'Difficulties in Emotion Regulation Scale (DERS)' Questionnaire
Description
Patients will regularly complete the 36-item DERS questionnaire (worst score = 180, best score = 36) to assess emotional dysregulation.
Time Frame
12 months
Title
'Yale-Brown Obsessive Compulsive Scale (Y-BOCS)' Questionnaire
Description
Patients will regularly complete the 10-item Y-BOCS questionnaire (worst score = 40, best score = 0) to assess severity of obsessive and compulsive symptoms
Time Frame
12 months
Title
'Binge Eating Scale (BES)' Questionnaire
Description
Patients will regularly complete the 16-item BES questionnaire (worst score = 43, best score = 0) to assess binge eating symptoms
Time Frame
12 months
Title
'Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS)' Questionnaire
Description
Patients will regularly complete the 19-item YBC-EDS questionnaire (worst score = 32, best score = 0) to assess eating-related preoccupations and rituals
Time Frame
12 months
Title
'Emotional Eating Scale (EES)' Questionnaire
Description
Patients will regularly complete the 25-item EES questionnaire (worst score = 100, best score = 0) to assess their emotional relationship with food.
Time Frame
12 months
Title
'Power of Food (POF)' Questionnaire
Description
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.
Time Frame
12 months
Title
'Eating Disorder Examination Questionnaire (EDE-Q)'
Description
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.
Time Frame
12 months
Title
'Yale Food Addiction Scale (YFAS)' Questionnaire
Description
Patients will regularly complete the 25-item YFAS (higher numbers = more severe symptoms) to assess the severity of food addiction.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gavin Elias
Phone
4166035800
Ext
6200
Email
gavin.elias@uhnresearch.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Martha Lenis, BHA
Phone
416 603 5800
Ext
2797
Email
martha.lenis@uhnresearch.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andres Lozano
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital, University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gavin Elias

12. IPD Sharing Statement

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Deep Brain Stimulation for Morbid Obesity

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