CompletedNot Applicable

Deep Brain Stimulation Effects on Weight Change and Metabolic Rate

United States3 participantsStarted 2013-08

Plain-language 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.

Who can participate

SexALL

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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

What they're measuring

Change in Metabolic Rate

Timeframe: One week of testing for each subject.

Trial details

NCT IDNCT01933113

SponsorAllegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-07

Results submitted2017-10-10

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