Deep Brain Stimulation Effects on Weight Change and Metabolic Rate
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/10/2019 |
| Start Date: | August 2013 |
| End Date: | July 2015 |
Effects of Deep Brain Stimulation of the Lateral Hypothalamic Area on Weight Change and Metabolic Rate
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.
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undergone placement of the DBS electrode in the pilot study, one subject was withdrawn from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.
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.
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
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