Deep Brain Stimulation for Morbid Obesity

University Health Network, Toronto6 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obesity Obesity, Morbid

Interventions

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Toronto Western Hospital, University Health Network

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events

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

Time frame: 12 months

Secondary Outcomes

Weight

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

Time frame: 12 months

'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.

Time frame: 12 months

'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).

Time frame: 12 months

'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.

Time frame: 12 months

'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.

Time frame: 12 months

'Difficulties in Emotion Regulation Scale (DERS)' Questionnaire

Data from ClinicalTrials.gov

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