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This study focuses on lateral hypothalamic area (LHA) deep brain stimulation (DBS) for severe obesity. In a previous pilot study, three subjects were implanted with a DBS electrode into the LHA under an Investigational Device Exemption (IDE) and IRB approved study at West Virginia University. That study demonstrated the safety of DBS of the LHA in these patients. These patients, who met the enrollment criteria of having prior placement of LHA DBS in accordance with previous study protocol, were eligible for this study with a goal of determining optimal DBS settings.
The goal of this study was to investigate changes in Resting Metabolic Rate (RMR) at different settings during stimulation of the LHA with DBS and to find the optimal setting for increasing the RMR in two patients that previously were implanted. Although 3 subjects had undergone placement of the DBS electrode in the pilot study, one subject was withdrawn from this study due to a lead breakage and medical instability pertaining to an unrelated abdominal infection.
Each subject utilized the metabolic chambers and Deltatrac II Metabolic Carts (SensorMedics Corporation, Anaheim, California or Datex-Ohmeda, Helsinki, Finland) at Pennington Biomedical Research Center (PBRC), in Baton Rouge, Louisiana to objectively measure the correlation of their metabolic rate to various novel settings on the DBS for a one week period.
The schedule for the metabolic testing included: Day 0 baseline overnight chamber with no stimulation. Days 1-4 Resting metabolic rate (RMR) will be performed hourly with variable LHS DBS settings. The settings will be changed approximately every 15 minutes after the DBS settings are changed. Day 4 overnight chamber at ideal metabolic rate setting. After RMR test on Day 4, the subject will have a dual-energy x-ray absorptiometry (DXA) scan performed to assess body composition.
Subjects were also be seen in clinic as often as every month but no less than every 3 months to assess changes in weight until the study ended.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DBS of the Lateral Hypothalamic Area | Experimental | Single Arm: Deep Brain Stimulation of LHA for maximum RMR On days 1-4, subjects stayed in the inpatient unit to have metabolic weight, temperature, and resting metabolic rate (RMR) measured at different settings. Metabolic testing RMR measurement: A clear plastic hood was placed over the head and chest Oxygen intake and carbon dioxide out-put were measured to determine how many calories were burned during the next 15-30 minutes. Each hour for the next seven hours, DBS settings were changed and the above process was repeated. On Day 4, a DXA scan was performed to assess body composition. Primary endpoint is the determination of optimal settings |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep Brain Stimulation of the Lateral Hypothalamic Area | Device | Deep Brain Stimulation of the Lateral Hypothalamic Area |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Metabolic Rate | Metabolic rate of subjects will be measured while at Pennington Biomedical Research Center. Percentage of change in these parameters will be measured. | One week of testing for each subject. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald M Whiting, MD | West Penn Allegheny Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allegheny Health Network | Pittsburgh | Pennsylvania | 15212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23560573 | Background | Whiting DM, Tomycz ND, Bailes J, de Jonge L, Lecoultre V, Wilent B, Alcindor D, Prostko ER, Cheng BC, Angle C, Cantella D, Whiting BB, Mizes JS, Finnis KW, Ravussin E, Oh MY. Lateral hypothalamic area deep brain stimulation for refractory obesity: a pilot study with preliminary data on safety, body weight, and energy metabolism. J Neurosurg. 2013 Jul;119(1):56-63. doi: 10.3171/2013.2.JNS12903. Epub 2013 Apr 5. | |
| 30315980 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single arm | DBS of the LHA Deep Brain Stimulation of the Lateral Hypothalamic Area |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single arm | DBS of the LHA Deep Brain Stimulation of the Lateral Hypothalamic Area |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Metabolic Rate | Metabolic rate of subjects will be measured while at Pennington Biomedical Research Center. Percentage of change in these parameters will be measured. | Posted | Median | Standard Deviation | percentage of increase in REM and SEE | One week of testing for each subject. |
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Subjects were followed for a total of one week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single arm | Deep Brain Stimulation (DBS) of the Lateral Hypothalamic Area (LHA) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Donald Whiting, MD | Allegheny Health Network | 412-359-6200 | donald.whiting@ahn.org |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Background |
| Whiting AC, Sutton EF, Walker CT, Godzik J, Catapano JS, Oh MY, Tomycz ND, Ravussin E, Whiting DM. Deep Brain Stimulation of the Hypothalamus Leads to Increased Metabolic Rate in Refractory Obesity. World Neurosurg. 2019 Jan;121:e867-e874. doi: 10.1016/j.wneu.2018.10.002. Epub 2018 Oct 11. |
| Participants |
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| Sex: Female, Male | One subject was withdrawn due to a lead breakage and medical instability pertaining to an unrelated abdominal infection. | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| BMI | Chronic obesity as defined as a BMI over 40 | One subject was withdrawn due to lead fracture and unrelated abdominal infection leaving 2 evaluable subjects | Count of Participants | Participants |
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| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |