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Pittsburgh, Pennsylvania 15212


Purpose:

The study is a continuation of the clinical pilot study of lateral hypothalamic area (LHA) deep brain stimulation (DBS) for severe obesity. Patients who met the enrollment criteria underwent stereotactic placement of bilateral hypothalamic chronic stimulating electrodes. The current trial will continue to monitor these subjects as well as objectively measure metabolic rate (including energy expenditure, respiratory quotient, oxygen consumption, and carbon dioxide production).


Study summary:

The intent of this protocol to continue to monitor effects of deep brain stimulation (DBS) on the lateral hypothalamic area (LHA) on the metabolic rate in the treatment of chronic refractory obesity. Three subjects have been previously implanted in an IDE study at West Virginia University. The subjects continue to be monitored and data is gathered on weight loss, metabolism and any other effects or side effects over time. The subjects will be seen as often as every month but no less than every three months at the outpatient clinic. They will be weighed and asked about changes in their overall health. Their stimulators will be interrogated for use and battery status. All device related adverse events will be captured as well as any non-device related serious adverse events. In addition, each subject will utilize 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 will include: 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.


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


NCT ID:

NCT01933113


Primary Contact:

Principal Investigator
Donald M Whiting, MD
West Penn Allegheny Health System


Backup Contact:

N/A


Location Contact:

Pittsburgh, Pennsylvania 15212
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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