Deep Brain Stimulation Effects on Weight Change and Metabolic Rate
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|ClinicalTrials.gov Identifier: NCT01933113|
Recruitment Status : Completed
First Posted : September 2, 2013
Results First Posted : January 8, 2019
Last Update Posted : January 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Device: Deep Brain Stimulation of the Lateral Hypothalamic Area||Not Applicable|
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 Although 3 subjects had undergone placement of the DBS electrode in the pilot study, one subject was withdrawn from this study due to a lead breakage and medical instability pertaining to an unrelated abdominal infection.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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Deep Brain Stimulation of the Lateral Hypothalamic Area on Weight Change and Metabolic Rate|
|Actual Study Start Date :||August 2013|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
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
- Change in Metabolic Rate [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01933113
|United States, Pennsylvania|
|Allegheny Health Network|
|Pittsburgh, Pennsylvania, United States, 15212|
|Principal Investigator:||Donald M Whiting, MD||West Penn Allegheny Health System|