Deep Brain Stimulation for the Treatment of Refractory Morbid Obesity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Incidence of Treatment-Emergent Adverse Events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Deep Brain Stimulation (Device)
Outcomes
Primary Outcomes
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 Outcomes
- Weight(12 months)
- 'Quality of Life Scale' Questionnaire(12 months)
- 'Generalized Anxiety Disorder 7-item (GAD-7)' Questionnaire(12 months)
- 'Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS)' Questionnaire(12 months)
- 'Emotional Eating Scale (EES)' Questionnaire(12 months)
- 'Eating Disorder Examination Questionnaire (EDE-Q)'(12 months)
- 'Binge Eating Scale (BES)' Questionnaire(12 months)
- 'Yale Food Addiction Scale (YFAS)' Questionnaire(12 months)
- 'Difficulties in Emotion Regulation Scale (DERS)' Questionnaire(12 months)
- 'Patient Health Questionnaire (PHQ-9)' Questionnaire(12 months)
- 'Power of Food (POF)' Questionnaire(12 months)
- 'Behavioral Inhibition System/Behavioral Activation System Scales (BIS/BAS Scales)' Questionnaire(12 months)
- 'Yale-Brown Obsessive Compulsive Scale (Y-BOCS)' Questionnaire(12 months)
Investigators
Andres M. Lozano
Neurosurgeon, Professor of Surgery
University Health Network, Toronto