Clinical trial NCT03650309: Deep Brain Stimulation for Morbid Obesity
Official title: Deep Brain Stimulation for the Treatment of Refractory Morbid Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Obesity, Morbid
Keywords: Deep Brain Stimulation
Functional Neurosurgery
Neuromodulation
Bariatrics
Weight Loss
Addiction
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: Weight
timeFrame: 12 months
measure: 'Quality of Life Scale' Questionnaire
timeFrame: 12 months
measure: 'Behavioral Inhibition System/Behavioral Activation System Scales (BIS/BAS Scales)' Questionnaire
timeFrame: 12 months
measure: 'Patient Health Questionnaire (PHQ-9)' Questionnaire
timeFrame: 12 months
measure: 'Generalized Anxiety Disorder 7-item (GAD-7)' Questionnaire
timeFrame: 12 months
measure: 'Difficulties in Emotion Regulation Scale (DERS)' Questionnaire
timeFrame: 12 months
measure: 'Yale-Brown Obsessive Compulsive Scale (Y-BOCS)' Questionnaire
timeFrame: 12 months
measure: 'Binge Eating Scale (BES)' Questionnaire
timeFrame: 12 months
measure: 'Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS)' Questionnaire
timeFrame: 12 months
measure: 'Emotional Eating Scale (EES)' Questionnaire
timeFrame: 12 months
measure: 'Power of Food (POF)' Questionnaire
timeFrame: 12 months
measure: 'Eating Disorder Examination Questionnaire (EDE-Q)'
timeFrame: 12 months
measure: 'Yale Food Addiction Scale (YFAS)' Questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital, University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Andres Lozano
role: PRINCIPAL_INVESTIGATOR
References: