Deep Brain Stimulation Effects on Weight Change and Metabolic Rate
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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 Although 3 subjects had undergone placement of the DBS electrode in the pilot study, one subject was withdrawn from this study due to a lead breakage and medical instability pertaining to an unrelated abdominal infection.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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DBS of the Lateral Hypothalamic Area 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 |
Device: Deep Brain Stimulation of the Lateral Hypothalamic Area
Deep Brain Stimulation of the Lateral Hypothalamic Area
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in Metabolic Rate [One week of testing for each subject.]
Metabolic rate of subjects will be measured while at Pennington Biomedical Research Center. Percentage of change in these parameters will be measured.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Prior placement of LHA DBS in accordance with previous study protocol
Exclusion Criteria:
-
Not a participant of the original LHA DBS study
-
Prior brain surgery, excluding the placement of LHA DBS
-
Taking medications with a recognized adverse event of weight change.
-
Diagnosis of a neurological disorder, such as multiple sclerosis or stroke.
-
Concurrent use of weight-loss prescription drug therapy or the use of over- the-counter weight loss preparations.
-
Unable to participate in scheduled study visits
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Allegheny Health Network | Pittsburgh | Pennsylvania | United States | 15212 |
Sponsors and Collaborators
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Investigators
- Principal Investigator: Donald M Whiting, MD, West Penn Allegheny Health System
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- DBS 5583
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Single Arm |
|---|---|
| Arm/Group Description | DBS of the LHA Deep Brain Stimulation of the Lateral Hypothalamic Area |
| Period Title: Overall Study | |
| STARTED | 3 |
| COMPLETED | 2 |
| NOT COMPLETED | 1 |
Baseline Characteristics
| Arm/Group Title | Single Arm |
|---|---|
| Arm/Group Description | DBS of the LHA Deep Brain Stimulation of the Lateral Hypothalamic Area |
| Overall Participants | 3 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
3
100%
|
| >=65 years |
0
0%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
2
66.7%
|
| Male |
1
33.3%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
3
100%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
3
100%
|
| BMI (Count of Participants) | |
| Count of Participants [Participants] |
2
66.7%
|
Outcome Measures
| Title | Change in Metabolic Rate |
|---|---|
| Description | Metabolic rate of subjects will be measured while at Pennington Biomedical Research Center. Percentage of change in these parameters will be measured. |
| Time Frame | One week of testing for each subject. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Single Arm |
|---|---|
| Arm/Group Description | DBS of the LHA Deep Brain Stimulation of the Lateral Hypothalamic Area |
| Measure Participants | 2 |
| Sleep Energy Expenditure (SEE) |
7.6
(3.9598)
|
| Resting Metabolic Rate (RMR) |
18
(2.8284)
|
Adverse Events
| Time Frame | Subjects were followed for a total of one week | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Single Arm | |
| Arm/Group Description | Deep Brain Stimulation (DBS) of the Lateral Hypothalamic Area (LHA) | |
All Cause Mortality |
||
| Single Arm | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/3 (0%) | |
Serious Adverse Events |
||
| Single Arm | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/3 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Single Arm | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/3 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Donald Whiting, MD |
|---|---|
| Organization | Allegheny Health Network |
| Phone | 412-359-6200 |
| donald.whiting@ahn.org |
- DBS 5583