Deep Brain Stimulation Effects in Patients With Chronic Refractory Obesity

January 23, 2025 updated by: donald whiting

Pilot Study to Evaluate Deep Brain Stimulation (DBS) of the Lateral Hypothalamic Area (LHA) on Energy Balance and Feeding Behavior in Patients With Chronic Refractory Obesity

This is a pilot study to evaluate the safety and efficacy of deep brain stimulation (DBS) of the lateral hypothalamic area (LHA) as a treatment for chronic refractory obesity. This study will include 6 individuals with chronic refractory obesity, that have failed other treatments including gastric bypass surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Six (N = 6) subjects with chronic refractory obesity will receive bilateral DBS implants in the LHA using the Boston Scientific Vercise Gevia DBS system. The primary objective is to evaluate the safety of DBS of the LHA using the current-driven Boston Scientific device and compare that to the safety data for our previous pilot using the voltage-driven DBS system for the treatment of chronic refractory obesity. The primary efficacy objective is to determine if DBS of the LHA can affect energy balance (i.e. energy intake and/or energy expenditure) in these patients. Secondary outcomes include quality of life outcomes and changes in feeding behaviors. Study participants will undergo a two-part DBS implantation procedure for placement of DBS electrodes in the LHA. Following this procedure, subjects with complete resting metabolic rate (RMR) testing to determine the optimal settings for the LHA stimulation. If effective, DBS technology might offer severely obese adults (BMI of ≥50 kg/m2), who have failed traditional therapy, a non-destructive, adaptable, reversible neurosurgical option for altering eating habits leading to sustained weight loss in the long-term.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15229
        • Allegheny General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male and female patients age ≥ 22 years and < 65 years old with a BMI of ≥ 40 kg/m2.
  2. 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).
  3. Stable at their present weight (+/- 3 kg) for a 12-month period.
  4. Neuropsychiatric evaluation must not reveal any issues that will be an impediment to subject's participation (as listed in Exclusion Criteria 2, 3 and 4).
  5. Karnofsky Performance Score >60.
  6. Platelet count >125,000 per cubic mm.
  7. Prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits.

Exclusion Criteria:

  1. Any intracranial abnormality or medical condition that would contraindicate DBS surgery.
  2. Have a history that includes a prior suicide attempt.
  3. Have any significant psychiatric condition likely to compromise the subject's ability to comply with requirements of the study protocol (e.g. bipolar, schizophrenia, mood disorder with psychotic features, cluster B personality disorders) or have any prior history of schizophrenia or bipolar disorder or active psychotic episodes.
  4. Have a current diagnosis of major depressive episode per DSM-IV (Diagnostics and Statistical Manual of Mental Disorders) criteria or has a current BDI-II score ≥ 17.
  5. Any current drug or alcohol abuse, per DSM-IV criteria or any history of substance abuse (alcohol or other drug) or dependence during the past 12 months.
  6. Any history of recurrent or unprovoked seizures.
  7. Any history of hemorrhagic stroke.
  8. Any diagnosis of acute myocardial infarction or cardiac arrest within previous 6 months.
  9. Any diagnosis of a neurological disorder, such as multiple sclerosis, stroke, Parkinson's disease, severe brain atrophy or the presence of subdural hygromas or subdural hematomas.
  10. Any history of hypothyroidism.
  11. Any history of demonstrated binge eating.
  12. Concurrent use of weight-loss prescription drug therapy or the use of over-the-counter weight loss preparations.
  13. Any prior intracranial surgery or device implantation.
  14. Any other active implanted devices (e.g., spinal cord stimulator, cochlear implant, pacemaker, vagus nerve stimulator) and /or drug delivery pumps, whether turned on or off. Passive implants (e.g., knee prostheses) would be allowed provided that they would not interfere with the DBS.
  15. Any previously implanted Vagus Nerve Stimulation (VNS) patients.
  16. A condition requiring or likely to require the use of Magnetic Resonance Imaging (MRI), diathermy or electroconvulsive therapy (ECT).
  17. Likely to require the use of monopolar cautery, radio-frequency (RF) procedures, external defibrillation, lithotripsy, radiation therapy or transcranial stimulation.
  18. Currently on any anticoagulant medications that cannot be discontinued during perioperative period.
  19. Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, (e.g. hepatitis or HIV).
  20. Any terminal illness with life expectancy of < 1 year.
  21. Any diagnosis of malignancy (except basal cell of skin) within the past five years.
  22. Any unresolved infection, a coagulopathy or significant cardiac or other medical risk factor for surgery.
  23. Current or future risk of being immunocompromised (due to medications, disease factors, illness, etc.) that might significantly increase risk of infection.
  24. Participation in any other clinical trial (e.g. drug, device, or biologics) concurrently or within the preceding 30 days. Participation in any other study will be allowed per investigator/sponsor discretion only.
  25. Plan to receive any procedure that involves sudden jerking motions of the head or neck (e.g. certain chiropractic therapies) or massage and manipulation directly over the leads in the scalp, neck or chest, at any time during the study.
  26. A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.
  27. Not able to speak, write and read in English language as determined by the investigator.
  28. Overall intellectual abilities below a standard score of 80 based on results from the Wechsler Abbreviated Scale of Intelligence (WASI; Wechsler, 1999)
  29. Unable to fit into MRI or CT (Maximum weight limit is 180 kg (396 lb.).
  30. Plasma pre-albumin < 14 mg/dL
  31. Obesity as part of another medical condition, neurological injury or lesions, related to medication side effect, or as part of a genetic syndrome (i.e. Prader-Willi Syndrome, Leptin deficiency, etc.)
  32. Be eligible for bariatric surgery revision including gastric outlet exclusion, gastrogastric fistula or other reasons that would qualify for a revision of their gastric bypass
  33. Unable or unwilling to follow up for scheduled clinic visits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LHA DBS
Subjects will receive bilateral DBS of the LHA
Device: DBS of the LHA
Deep Brain Stimulation of the Lateral Hypothalamic Area
Other Names:
  • Vercise Gevia™ Deep Brain Stimulator System
  • Suretek Model DB-4600-C
  • Vercise Cartesia Directional Leads Model DB-2202-45
  • OR Cable and Extension Model DB-4100A
  • 8 Contact Extension Model NM-3138-55
  • Vercise Charging System Model DB-64125-US
  • Vercise Gevia 16 Contact IPG Kit Model DB-1200-S
  • Vercise DBS Remote Control 3 Kit Model DB-5552-1

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety - Complication Rates
Time Frame: 12 months
Adverse Events
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Resting metabolic rate (RMR)
Time Frame: Baseline, 2 months, 4-5 months and 20 months post-surgery
RMR assessment of energy expenditure
Baseline, 2 months, 4-5 months and 20 months post-surgery
Energy intake
Time Frame: 2 months and 4-5 months post-surgery
Assessment of energy intake through ad libitum test meals
2 months and 4-5 months post-surgery
Impact of weight on quality of life: IWQOL-Lite
Time Frame: Baseline, 2 months and 4-5 months post-surgery
Impact of Weight on Quality of Life Questionnaire (IWQOL-Lite). [Feeding behavior assessment]. There are 31 items by which the subject will respond to statements under 5 domains. Responses include: Always true, Usually true, Sometimes true, Rarely true, and Never true. All responses are totaled for a final score. Scores range from 0 to 100, with 100 representing the best quality of life.
Baseline, 2 months and 4-5 months post-surgery
Binge Eating Scale (BES)
Time Frame: Baseline, 2 months and 4-5 months post-surgery
Eating Habits Checklist/Binge Eating Scale (BES). [Feeding behavior assessment]. There are 16 items that subjects will respond to. Each question has 3-4 separate responses assigned a numerical value. The score range is from 0-46. Higher scores equate to greater binging behavior.
Baseline, 2 months and 4-5 months post-surgery
Yale Food Addiction Scale
Time Frame: Baseline, 2 months and 4-5 months post-surgery
Yale Food Addiction Scale. [Feeding behavior assessment]. There are 25 self-reported questions in dichotomous and Likert-type format. Food addiction is recognized when a subject meets at least three of the symptom criteria. The more symptoms met, the more severe the food addiction.
Baseline, 2 months and 4-5 months post-surgery
Power of Food Scale
Time Frame: Baseline, 2 months and 4-5 months post-surgery
Power of Food Scale. [Feeding behavior assessment]. There are 21 items that subjects will assign a response to. The scale is as follows: 1=I don't agree at all, 2=I agree a little, 3=I agree somewhat, 4=I agree, 5=I strongly agree. All items are scored so that a higher item score indicates a greater responsiveness to the food environment.
Baseline, 2 months and 4-5 months post-surgery
Eating inventory
Time Frame: Baseline, 2 months and 4-5 months post-surgery
Eating Inventory (EI). [Feeding behavior assessment]. There are 51 items consisting of three subscales. Scores range from a minimum of 0-0-0 to a maximum of 21-16-14. Higher scores are indicative of a greater level of the eating habits for the respective subscales.
Baseline, 2 months and 4-5 months post-surgery
Body shape perception
Time Frame: Baseline, 2 months and 4-5 months post-surgery
Body Shape Questionnaire (BSQ). [Feeding behavior assessment]. There are 34 items that subjects will assign a response to. The scale is as follows: 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Very Often, 6=Always. The maximum score is 204, and a higher score indicates more dissatisfaction and discomfort with the body experience.
Baseline, 2 months and 4-5 months post-surgery
Food craving inventory
Time Frame: Baseline, 2 months and 4-5 months post-surgery
Food Craving Inventory. [Feeding behavior assessment]. For each of the foods listed (37), subjects will rate the frequency of cravings. The scale is as follows: A=Never, B=Rarely (once or twice), C=Sometimes, D=Often, E=Always/almost every day. Cravings are measured for five types of foods. A total score is also obtained that measures the general construct of food cravings. Higher scores are indicative of more intense cravings.
Baseline, 2 months and 4-5 months post-surgery
Food preferences
Time Frame: Baseline, 2 months and 4-5 months post-surgery
Food Preference Questionnaire. [Feeding behavior assessment]. Subjects rate their liking of 62 individual foods on a 5-point Likert scale. The scale is as follows: 1=Dislike a lot, 2=Dislike a little, 3=Neither like nor dislike, 4=Like a little, 5=Like a lot. Higher scores indicate a higher preference.
Baseline, 2 months and 4-5 months post-surgery
Delayed reward discounting
Time Frame: Baseline, 2 months and 4-5 months post-surgery
Monetary Choice Questionnaire. [Feeding behavior assessment]. There are 21 items that subjects will indicate a response. The scale is as follows: 0=smaller reward today, 1=larger reward in the specified number of days. The questionnaire is scored by calculating where the respondent's answers place them amid reference discounting curves, where placement amid steeper curves indicates higher levels of impulsivity.
Baseline, 2 months and 4-5 months post-surgery
Appetitive sensations
Time Frame: Baseline, 2 months and 4-5 months post-surgery
Visual analog scale (VAS) assessment. [Feeding behavior assessment]. Subjects will rank appetitive sensations on a scale from 0-10.
Baseline, 2 months and 4-5 months post-surgery
Quality of life measure: SF-36
Time Frame: Baseline, 2 months and 4-5 months post-surgery
Short Form-36 (SF-36). Subjects will rate responses to each of 36 items, (Likert and yes/no responses). Scores for each scale range from 0-100. The lower the score the more disability.
Baseline, 2 months and 4-5 months post-surgery
Depression score
Time Frame: Baseline, 2 months and 4-5 months post-surgery
Beck Depression Inventory (BDI-II). There are 21 items where subjects will rate their responses on a Likert scale from 0-3. Total scores range from 0-63. Higher total scores indicate more severe depressive symptoms.
Baseline, 2 months and 4-5 months post-surgery
Changes in metabolic hormone profiles
Time Frame: 2 months and 4-5 months post-surgery
Biochemical battery of tests. Blood draw for GLP1, PYY, Ghrelin (total and active) - Fasting
2 months and 4-5 months post-surgery
Body mass index
Time Frame: 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
Body Mass Index (BMI)
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
Change in DXA body composition
Time Frame: 2 months and 4-5 months post-surgery
Change in body composition. Measured by dual-energy x-ray absorptiometry (DXA) scan
2 months and 4-5 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
donald whiting

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Donald Whiting, MD, Allegheny Health Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 7, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Obesity IDE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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