NCT03650309

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 28, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2022

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

3.4 years

First QC Date

August 10, 2018

Last Update Submit

May 7, 2024

Conditions

ObesityObesity, Morbid

Keywords

Deep Brain StimulationFunctional NeurosurgeryNeuromodulationBariatricsWeight LossAddiction

Outcome Measures

Primary Outcomes (1)

  • Incidence of Treatment-Emergent Adverse Events

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

    12 months

Secondary Outcomes (13)

  • Weight

    12 months

  • 'Quality of Life Scale' Questionnaire

    12 months

  • 'Behavioral Inhibition System/Behavioral Activation System Scales (BIS/BAS Scales)' Questionnaire

    12 months

  • 'Patient Health Questionnaire (PHQ-9)' Questionnaire

    12 months

  • 'Generalized Anxiety Disorder 7-item (GAD-7)' Questionnaire

    12 months

  • +8 more secondary outcomes

Study Arms (1)

Deep Brain Stimulation

EXPERIMENTAL

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.

Device: Deep Brain Stimulation

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.

Deep Brain Stimulation

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital, University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

ObesityObesity, MorbidWeight LossBehavior, Addictive

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesCompulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Andres Lozano

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neurosurgeon, Professor of Surgery

Study Record Dates

First Submitted

August 10, 2018

First Posted

August 28, 2018

Study Start

September 1, 2018

Primary Completion

January 23, 2022

Study Completion

July 23, 2022

Last Updated

May 8, 2024

Record last verified: 2024-05

Locations

CA(1)