ObesityNCT04453020
Deep Brain Stimulation Effects in Patients With Chronic Refractory Obesity
A study testing DBS of the LHA in people with Obesity, run by donald whiting at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- DBS of the LHA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2022to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients age ≥ 22 years and < 65 years old with a BMI of ≥ 40 kg/m2.
- 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).
- Stable at their present weight (+/- 3 kg) for a 12-month period.
- 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).
- Karnofsky Performance Score >60.
- Platelet count >125,000 per cubic mm.
- Prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits.
Who cannot join
- Any intracranial abnormality or medical condition that would contraindicate DBS surgery.
- Have a history that includes a prior suicide attempt.
- 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.
- 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.
- 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.
- Any history of recurrent or unprovoked seizures.
Show all 33Show fewer
- Any history of hemorrhagic stroke.
- Any diagnosis of acute myocardial infarction or cardiac arrest within previous 6 months.
- 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.
- Any history of hypothyroidism.
- Any history of demonstrated binge eating.
- Concurrent use of weight-loss prescription drug therapy or the use of over-the-counter weight loss preparations.
- Any prior intracranial surgery or device implantation.
- 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.
- Any previously implanted Vagus Nerve Stimulation (VNS) patients.
- A condition requiring or likely to require the use of Magnetic Resonance Imaging (MRI), diathermy or electroconvulsive therapy (ECT).
- Likely to require the use of monopolar cautery, radio-frequency (RF) procedures, external defibrillation, lithotripsy, radiation therapy or transcranial stimulation.
- Currently on any anticoagulant medications that cannot be discontinued during perioperative period.
- 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).
- Any terminal illness with life expectancy of < 1 year.
- Any diagnosis of malignancy (except basal cell of skin) within the past five years.
- Any unresolved infection, a coagulopathy or significant cardiac or other medical risk factor for surgery.
- Current or future risk of being immunocompromised (due to medications, disease factors, illness, etc.) that might significantly increase risk of infection.
- 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.
- 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.
- A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.
- Not able to speak, write and read in English language as determined by the investigator.
- Overall intellectual abilities below a standard score of 80 based on results from the Wechsler Abbreviated Scale of Intelligence (WASI; Wechsler, 1999)
- Unable to fit into MRI or CT (Maximum weight limit is 180 kg (396 lb.).
- Plasma pre-albumin < 14 mg/dL
- 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.)
- 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
- Unable or unwilling to follow up for scheduled clinic visits
Trial locations and contacts
1 site in 1 country.
United States1 site
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15229
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- DBS of the LHA
- Keywords
- Deep Brain Stimulation, Lateral Hypothalamic Area, Feeding Behaviors, Energy Balance
- Medical subject headings
- Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBS of the LHADevice
Also called 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
Deep Brain Stimulation of the Lateral Hypothalamic Area
| Study group | Role | What they receive |
|---|---|---|
| LHA DBS | Experimental | Subjects will receive bilateral DBS of the LHA Receives: Device: DBS of the LHA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Complication Rates
Adverse Events
Measured: 12 months
Secondary outcomes (17)
Resting metabolic rate (RMR)
RMR assessment of energy expenditure
Measured: Baseline, 2 months, 4-5 months and 20 months post-surgery
Energy intake
Assessment of energy intake through ad libitum test meals
Measured: 2 months and 4-5 months post-surgery
Impact of weight on quality of life: IWQOL-Lite
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.
Measured: Baseline, 2 months and 4-5 months post-surgery
Binge Eating Scale (BES)
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.
Measured: Baseline, 2 months and 4-5 months post-surgery
Yale Food Addiction Scale
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.
Measured: Baseline, 2 months and 4-5 months post-surgery
Power of Food Scale
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.
Measured: Baseline, 2 months and 4-5 months post-surgery
Eating inventory
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.
Measured: Baseline, 2 months and 4-5 months post-surgery
Body shape perception
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.
Measured: Baseline, 2 months and 4-5 months post-surgery
Food craving inventory
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.
Measured: Baseline, 2 months and 4-5 months post-surgery
Food preferences
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.
Measured: Baseline, 2 months and 4-5 months post-surgery
Delayed reward discounting
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.
Measured: Baseline, 2 months and 4-5 months post-surgery
Appetitive sensations
Visual analog scale (VAS) assessment. [Feeding behavior assessment]. Subjects will rank appetitive sensations on a scale from 0-10.
Measured: Baseline, 2 months and 4-5 months post-surgery
Quality of life measure: SF-36
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.
Measured: Baseline, 2 months and 4-5 months post-surgery
Depression score
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.
Measured: Baseline, 2 months and 4-5 months post-surgery
Changes in metabolic hormone profiles
Biochemical battery of tests. Blood draw for GLP1, PYY, Ghrelin (total and active) - Fasting
Measured: 2 months and 4-5 months post-surgery
Body mass index
Body Mass Index (BMI)
Measured: 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
Change in body composition. Measured by dual-energy x-ray absorptiometry (DXA) scan
Measured: 2 months and 4-5 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start7 Feb 2022
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Why it stopped: The advent of GLP-1 medications for obesity has hampered successful recruitment. No subjects were consented nor enrolled into this study since the start date.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- donald whiting
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor-investigator, donald whiting, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Investigators
- Donald Whiting, MD, Principal investigator, Allegheny Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453020
- Sponsor's protocol ID
- Obesity IDE
- Status last verified
- Jan 2025
- First submitted
- 16 Jun 2020
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04453020
- Acronym / sponsor ID
- Obesity IDE
- Conditions
- Obesity
- Keywords
- Deep Brain Stimulation, Lateral Hypothalamic Area, Feeding Behaviors, Energy Balance
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The advent of GLP-1 medications for obesity has hampered successful recruitment. No subjects were consented nor enrolled into this study since the start date.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- donald whitingUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 1 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LHA DBS | Experimental | Device: DBS of the LHASubjects will receive bilateral DBS of the LHA |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female patients age ≥ 22 years and < 65 years old with a BMI of ≥ 40 kg/m2.
- 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).
- Stable at their present weight (+/- 3 kg) for a 12-month period.
- 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).
- Karnofsky Performance Score >60.
Key exclusion criteria (33 listed)
- Any intracranial abnormality or medical condition that would contraindicate DBS surgery.
- Have a history that includes a prior suicide attempt.
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBS of the LHAAlso: 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-4100ADeep Brain Stimulation of the Lateral Hypothalamic Area | Device | LHA DBS |
Primary outcome
Safety - Complication Rates
Time frame: 12 months
Adverse Events
17 secondary outcomes
Resting metabolic rate (RMR)
Time frame: Baseline, 2 months, 4-5 months and 20 months post-surgery
Energy intake
Time frame: 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
Binge Eating Scale (BES)
Time frame: Baseline, 2 months and 4-5 months post-surgery
Yale Food Addiction Scale
Time frame: Baseline, 2 months and 4-5 months post-surgery
Power of Food Scale
Time frame: Baseline, 2 months and 4-5 months post-surgery
Eating inventory
Time frame: Baseline, 2 months and 4-5 months post-surgery
Body shape perception
Time frame: Baseline, 2 months and 4-5 months post-surgery
Food craving inventory
Time frame: Baseline, 2 months and 4-5 months post-surgery
Food preferences
Time frame: Baseline, 2 months and 4-5 months post-surgery
Delayed reward discounting
Time frame: Baseline, 2 months and 4-5 months post-surgery
Appetitive sensations
Time frame: 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
Depression score
Time frame: Baseline, 2 months and 4-5 months post-surgery
Changes in metabolic hormone profiles
Time frame: 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
Change in DXA body composition
Time frame: 2 months and 4-5 months post-surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald Whiting, MD principal investigator
Allegheny Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBS of the LHA in people with Obesity, run by donald whiting at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Complication Rates (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.