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Neurostimulation

Deep Brain Stimulation for Obesity

N/A
Recruiting
Led By Andres Lozano
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Diagnosis of food dependence via Yale Food Addiction Scale (YFAS) criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will test if it is safe and feasible to use deep brain stimulation to treat morbid obesity. If successful, patients will be followed for 12 months after the operation.

Eligible Conditions
  • Obesity

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check β€œYes” for the criteria below
Select...
You are extremely overweight with a high body mass index (BMI) or have a condition called binge eating disorder that hasn't improved with recommended treatments.
Select...
You have been diagnosed with food addiction based on specific criteria from the Yale Food Addiction Scale (YFAS).
Select...
You have undergone bariatric surgery but did not achieve at least 50% weight loss, or you have a diagnosis of binge eating disorder for more than 18 months.
Select...
Your brain and nerves are working normally.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events
Secondary outcome measures
'Behavioral Inhibition System/Behavioral Activation System Scales (BIS/BAS Scales)' Questionnaire
'Binge Eating Scale (BES)' Questionnaire
'Difficulties in Emotion Regulation Scale (DERS)' Questionnaire
+10 more

Side effects data

From 2018 Phase 2 trial β€’ 53 Patients β€’ NCT01221948
23%
Fall
15%
Depression
8%
Hand fracture
8%
Restless legs syndrome
8%
Apathy
5%
Back pain
5%
Head injury
5%
Speech disorder
5%
Skeletal injury
5%
Tremor
5%
Gait disturbance
5%
Dystonia
5%
Paraesthesia
5%
Influenza
5%
Urinary tract infection
5%
Dyspepsia
3%
Akinesia
3%
Diabetes mellitus
3%
Intervertebral disc protrusion
3%
Device migration
3%
Postoperative wound infection
3%
Parkinson's disease
3%
Productive cough
3%
Fluid retention
3%
Skin laceration
3%
Respiratory depression
3%
Joint sprain
3%
Syncope
3%
Ingrowing nail
3%
Rib fracture
3%
Drug withdrawal syndrome
3%
Alcohol poisoning
3%
Contusion
3%
Cerebral microangiopathy
3%
Dysarthria
3%
Hypoaesthesia
3%
Memory impairment
3%
Movement disorder
3%
Monarthritis
3%
Neck pain
3%
Osteoarthritis
3%
Pain in extremity
3%
Spinal osteoarthritis
3%
Adverse drug reaction
3%
Cyst
3%
Implant site haematoma
3%
Oedema peripheral
3%
Pyrexia
3%
Pleural effusion
3%
Nerve root lesion
3%
Anxiety
3%
Cough
3%
Fibula fracture
3%
Thermal burn
3%
Sciatica
3%
Anger
3%
Bursitis
3%
Cystitis
3%
Helicobacter gastritis
3%
Implant site infection
3%
Localised infection
3%
Pneumonia
3%
Staphylococcal infection
3%
Confusional state
3%
Depressed mood
3%
Hallucination, auditory
3%
Impulse-control disorder
3%
Insomnia
3%
Panic attack
3%
Rapid eye movements sleep abnormal
3%
Bronchitis
3%
Ear infection
3%
Incision site infection
3%
Arthralgia
3%
Axillary pain
3%
Folate deficiency
3%
Hypertension
3%
Hypotension
3%
Thrombophlebitis
3%
Diplopia
3%
Macular degeneration
3%
Laboratory test abnormal
3%
Weight increased
3%
Pericardial effusion
3%
Seborrhoeic keratosis
3%
Urinary incontinence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Deep Brain Stimulation

Trial Design

1Treatment groups
Experimental Treatment
Group I: Deep Brain StimulationExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deep Brain Stimulation
2011
Completed Phase 2
~700

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,456 Previous Clinical Trials
482,793 Total Patients Enrolled
12 Trials studying Obesity
931 Patients Enrolled for Obesity
Andres LozanoPrincipal InvestigatorUniversity Health Network, Toronto
3 Previous Clinical Trials
267 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the qualifications for participating in this experiment?

"In order to join the study, individuals must be within the age range of 20 and 70 years old while also suffering from obesity. Currently, around 6 participants are being sought out for this trial."

Answered by AI

Are elderly individuals eligible for this investigation?

"This research is recruiting participants who are within the age range of 20-70 years old."

Answered by AI

Are physicians in this study currently enrolling participants?

"This research initiative, listed on clinicaltrials.gov and initially published in September 2018, is currently enrolling patients. The project was last updated on May 16th 2022"

Answered by AI

What is the current enrollment size for this research endeavor?

"Affirmative, the clinical trial information available on clinicaltrials.gov corroborates that recruitment is currently underway for this study. It was first posted in September 2018 and last modified in May 2022; 6 patients are needed from a single location."

Answered by AI
~1 spots leftby Mar 2025