Deep Brain Stimulation for Morbid Obesity

NCT ID: NCT03650309

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2022-07-23

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.

Conditions

Obesity; Obesity, Morbid

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Deep Brain Stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Andres M. Lozano

Neurosurgeon, Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andres Lozano

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

Toronto Western Hospital, University Health Network

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

17-5899

Identifier Type: -

Identifier Source: org_study_id