N/A
N=3
Deep Brain Stimulation Effects on Weight Change and Metabolic Rate
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01933113 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Change in Metabolic Rate — 7.6; 18 percentage of increase in REM and SEE
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Deep Brain Stimulation of the Lateral Hypothalamic Area (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Metabolic Rate |
7.6; 18 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01933113). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.