Obesity
Conditions
Keywords
Obesity, Deep Brain Stimulation, LHA
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.
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 Although 3 subjects had undergone placement of the DBS electrode in the pilot study, one subject was withdrawn from this study due to a lead breakage and medical instability pertaining to an unrelated abdominal infection.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.
Interventions
DEVICEDeep Brain Stimulation of the Lateral Hypothalamic Area
Deep Brain Stimulation of the Lateral Hypothalamic Area
Sponsors
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single arm DBS of the LHA
Deep Brain Stimulation of the Lateral Hypothalamic Area | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Fractured nonfunctioning lead. | 1 |
Baseline characteristics
| Characteristic | Single arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| BMI | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
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.
Time frame: One week of testing for each subject.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Single arm | Change in Metabolic Rate | Sleep Energy Expenditure (SEE) | 7.6 percentage of increase in REM and SEE | Standard Deviation 3.9598 |
| Single arm | Change in Metabolic Rate | Resting Metabolic Rate (RMR) | 18 percentage of increase in REM and SEE | Standard Deviation 2.8284 |