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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
Sponsor:
Information provided by (Responsible Party):
Donald M. Whiting, MD, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Device: Deep Brain Stimulation of the Lateral Hypothalamic Area Not Applicable

Detailed Description:

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 Although 3 subjects had undergone placement of the DBS electrode in the pilot study, one subject was withdrawn from this study due to a lead breakage and medical instability pertaining to an unrelated abdominal infection.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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
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
Other Names:
  • Devices used in this protocol:
  • Medtronic Activa TM SC model # 37603
  • Medtronic DBS lead model # 3389
  • Medtronic Extension model # 37086-60




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, Pennsylvania
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Investigators
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Principal Investigator: Donald M Whiting, MD West Penn Allegheny Health System

Publications:
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Responsible Party: Donald M. Whiting, MD, Principal Investigator, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
ClinicalTrials.gov Identifier: NCT01933113     History of Changes
Other Study ID Numbers: DBS 5583
First Posted: September 2, 2013    Key Record Dates
Results First Posted: January 8, 2019
Last Update Posted: January 8, 2019
Last Verified: December 2018
Keywords provided by Donald M. Whiting, MD, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute):
Obesity
Deep Brain Stimulation
LHA
Additional relevant MeSH terms:
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Body Weight Changes
Body Weight
Signs and Symptoms