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Deep Brain Stimulation for Obesity
Study Summary
This trial will test if a brain implant can help people with chronic obesity that have failed other treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am currently using prescription or over-the-counter weight loss drugs.I am currently diagnosed with a major depressive episode or my depression score is 17 or higher.My weight has been stable, within 3 kg, for the last year.You have had a Vagus Nerve Stimulation (VNS) device implanted in the past.My weight loss surgery didn't work, and there's no surgical fix.I have not been diagnosed with any severe neurological disorders.My obesity is due to another health condition, medication side effects, or a genetic syndrome.My doctor expects I have less than a year to live due to my illness.I do not have any major health issues like hepatitis or HIV that could affect the study.You currently abuse drugs or alcohol or have a history of substance abuse within the past year.I am between 22 and 65 years old with a BMI of 50 or more.I can care for myself but may not be able to do active work.I weigh less than 396 lbs and can fit into an MRI or CT scanner.I cannot or do not want to attend scheduled clinic visits.I do not have any ongoing infections, bleeding disorders, or major health risks for surgery.I do not plan to undergo procedures that involve sudden head or neck movements.I am a woman who could be pregnant, am pregnant, or am not using birth control.My weight loss surgery didn't work, and it can't be fixed with more surgery or procedures.You must not have any mental health issues that would make it difficult for you to participate in the study.I have not been diagnosed with any cancer (except skin cancer) in the last 5 years.I have had brain surgery or a device implanted in my brain.I am taking blood thinners that can't be stopped for surgery.I may need treatments like cautery or radiation therapy.You must not have any mental health conditions that would make it difficult for you to participate in the study.I am between 22 and 65 years old with a BMI of 50 or more.I have had seizures that happen without a known cause.I have had a bleeding stroke in the past.I have a history of hypothyroidism.I am at risk of being immunocompromised, which could increase my infection risk.I am eligible for a second bariatric surgery due to complications or other reasons.I don't have brain conditions that prevent DBS surgery.You have tried to harm yourself in the past.You have a history of binge eating episodes.I have not had a heart attack or cardiac arrest in the last 6 months.
- Group 1: LHA DBS
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What questions have other patients asked about this trial?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Allegheny General Hospital: < 24 hours
Average response time
- < 1 Day
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