Your session is about to expire
← Back to Search
Neurostimulation
Responsive Neurostimulation for Binge Eating Disorder (DBSLOC Trial)
N/A
Recruiting
Research Sponsored by Casey H. Halpern
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Failure of at least one weight loss medication
Previous Gastric Bypass Surgery lead to less than 50% of excess weight lost by 2 years after surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
DBSLOC Trial Summary
This trial is to assess the function and safety of a device, with secondary objectives including feasibility.
Who is the study for?
This trial is for adults with severe obesity (BMI 40-60) who've tried at least one weight loss medication without success. They must be able to attend clinic visits, follow study rules, and premenopausal women should use birth control. It's not for those with brain implants or pacemakers, or who can't fit in a CT scanner.Check my eligibility
What is being tested?
The trial is testing responsive neurostimulation, a device that may help control binge eating by sending electrical impulses to the brain. The focus is on how well the device works and its safety.See study design
What are the potential side effects?
Since this involves a medical device rather than medication, side effects might include discomfort at the implant site, potential infection risk from surgery, and possible changes in mood or behavior.
DBSLOC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have tried at least one weight loss medication without success.
Select...
I lost less than half of my excess weight 2 years after gastric bypass surgery.
DBSLOC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Count of Participants Exhibiting Overall Decrease in Loss of Control Episodes Per Week
Incidence of Treatment-Emergent Related Adverse Events [Safety and Tolerability]
DBSLOC Trial Design
1Treatment groups
Experimental Treatment
Group I: Responsive NeurostimulationExperimental Treatment1 Intervention
Surgical arm. Patients expected to receive treatment.
Find a Location
Who is running the clinical trial?
Casey H. HalpernLead Sponsor
1 Previous Clinical Trials
7 Total Patients Enrolled
Casey HalpernLead Sponsor
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,227 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand the study and agree to participate.You have a medical device in your brain that uses electrical energy.I have tried at least one weight loss medication without success.You have a device in your body like a pacemaker, defibrillator, or neurostimulator.You have trouble controlling your eating habits.I lost less than half of my excess weight 2 years after gastric bypass surgery.I weigh over 500lbs and cannot fit into a CT scanner.You have a body mass index (BMI) between 40 to 60, which is considered very high.I am able to understand and agree to the treatment plan.I can attend all clinic visits by myself or with help.
Research Study Groups:
This trial has the following groups:- Group 1: Responsive Neurostimulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are actively participating in this investigation?
"Affirmative. Evidence from clinicaltrials.gov suggests that this research endeavour, which was initially published on April 10th 2019, is presently recruiting participants. Approximately 6 individuals need to be enrolled at 1 separate medical facility."
Answered by AI
Can persons younger than seventy years of age partake in this research?
"This research study is currently accepting volunteers that are between 22 and 65 years of age."
Answered by AI
Is enrollment for this trial ongoing at the present time?
"According to data posted by clinicaltrials.gov, this medical experiment is actively seeking participants. The trial was initially announced on April 10th 2019 and recently updated during the 19th of April 2022."
Answered by AI
Who has the necessary qualifications to participate in this research?
"To be eligible for this medical trial, applicants must possess obesity and morbidity, as well as an age between 22 to 65. The investigators are looking for 6 participants in total."
Answered by AI
Who else is applying?
What site did they apply to?
Stanford University
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I have tried bairatric surgery, diet pills, weight watchers and alot of different diets. Nothing has worked for real weightloss
And recently noticed I'm back to binge eating.
PatientReceived no prior treatments
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger