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Device

Deep Brain Stimulation for Obesity

N/A
Recruiting
Led By Donald Whiting, MD
Research Sponsored by Donald M. Whiting, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stable at their present weight (+/- 3 kg) for a 12-month period.
Failure of bariatric surgery (gastric bypass) and subjects who have no endoscopically or surgically correctable causes for failed bariatric surgery. "Failed bariatric surgery" is determined using the modified Reinhold classification as patients who are currently more than 50% over ideal body weight at least 24 months after a technically successful surgery (as confirmed by a esophagogastroduodenoscopy (EGD) within the 6 months prior to ICF)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 weeks, 2 months, 4-5 months, 6 months, 9 months, 12 months, 15 months, 18 months, 20 months and 24 months post-surgery
Awards & highlights

Study Summary

This trial will test if a brain implant can help people with chronic obesity that have failed other treatments.

Who is the study for?
This trial is for adults aged 22-65 with severe obesity (BMI ≥ 50 kg/m2) who have been stable in weight for a year and whose bariatric surgery failed. They must not have any neuropsychiatric issues that could affect participation, no history of seizures or hemorrhagic stroke, and should not be at high risk of infection.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of deep brain stimulation (DBS) on the lateral hypothalamic area (LHA) in patients with chronic refractory obesity who haven't responded to other treatments including gastric bypass surgery.See study design
What are the potential side effects?
Potential side effects may include risks associated with brain surgery such as infection, bleeding, headache, nausea, changes in mood or behavior. Specific side effects related to DBS can also occur but are not detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My weight has been stable, within 3 kg, for the last year.
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My weight loss surgery didn't work, and there's no surgical fix.
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I am between 22 and 65 years old with a BMI of 50 or more.
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I can care for myself but may not be able to do active work.
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My weight loss surgery didn't work, and it can't be fixed with more surgery or procedures.
Select...
I am between 22 and 65 years old with a BMI of 50 or more.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 weeks, 2 months, 4-5 months, 6 months, 9 months, 12 months, 15 months, 18 months, 20 months and 24 months post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 weeks, 2 months, 4-5 months, 6 months, 9 months, 12 months, 15 months, 18 months, 20 months and 24 months post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety - Complication Rates
Secondary outcome measures
Appetitive sensations
Binge Eating Scale (BES)
Body mass index
+14 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: LHA DBSExperimental Treatment1 Intervention
Subjects will receive bilateral DBS of the LHA

Find a Location

Who is running the clinical trial?

Donald M. Whiting, MDLead Sponsor
donald whitingLead Sponsor
Boston Scientific CorporationIndustry Sponsor
717 Previous Clinical Trials
932,899 Total Patients Enrolled
3 Trials studying Obesity
91 Patients Enrolled for Obesity

Media Library

DBS of the LHA (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04453020 — N/A
Obesity Research Study Groups: LHA DBS
Obesity Clinical Trial 2023: DBS of the LHA Highlights & Side Effects. Trial Name: NCT04453020 — N/A
DBS of the LHA (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04453020 — N/A
Obesity Patient Testimony for trial: Trial Name: NCT04453020 — N/A

Frequently Asked Questions

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

Are there still openings in this clinical trial for potential participants?

"According to clinicaltrials.gov, this medical trial is still recruiting patients; the study was first made public on February 7th 2022 and has most recently been updated May 13th of the same year."

Answered by AI

What criteria must I meet to be admitted as a participant in this medical study?

"Eligibility for this particular project necessitates that candidates must have a BMI classified as "obese" and be aged between 22-65. Currently, the research team is aiming to include 6 people in their study."

Answered by AI

What is the total cohort size of this research effort?

"Affirmative. According to the information accessible on clinicaltrials.gov, this research study is presently enrolling volunteers. It was first shared on February 7th 2022 and recently updated on May 13th 2022. A total of 6 individuals need to be recruited at 1 medical facility."

Answered by AI

Is enrollment open to elderly individuals for this experimental research?

"As per the trial's inclusion criteria, only individuals aged between 22 and 65 are eligible to participate. However, there exist 202 trials targeting minors and 596 clinical trias for seniors."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Florida
Texas
Other
How old are they?
65+
18 - 65
What site did they apply to?
Allegheny General Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0
1
3+

What questions have other patients asked about this trial?

How much does this study pay? What type of implant? is there any compensation for the trial? How often do I need to be at the hospital?
PatientReceived no prior treatments

Why did patients apply to this trial?

To lose weight. I have tried all my life to lose weight, Nothing has worked.
PatientReceived 2+ prior treatments
I need to lose weight and I’ve tried some things but they didn’t work. I'm interested in this study to loose weight and maintain the weight loss.
PatientReceived no prior treatments
I have done everything to lose weight. I even had gastric sleeve surgery. I eat very but I lose nothing.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Allegheny General Hospital: < 24 hours
Average response time
  • < 1 Day
~2 spots leftby Feb 2025