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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)

Tracking Information
First Submitted Date  ICMJE August 23, 2013
First Posted Date  ICMJE September 2, 2013
Results First Submitted Date  ICMJE October 10, 2017
Results First Posted Date  ICMJE January 8, 2019
Last Update Posted Date January 8, 2019
Actual Study Start Date  ICMJE August 2013
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 28, 2013)
  • Weight loss. [ Time Frame: One year. ]
    Weight of subjects will be measured at each follow-up visit.
  • 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.
Change History Complete list of historical versions of study NCT01933113 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2013)
Collection of obesity related co-morbidities [ Time Frame: one year. ]
Reported co-morbidities will be collected from subjects, such as changes in blood sugar management, changes in blood pressure management, etc. This information will be solicited from subjects at each follow-up visit.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Deep Brain Stimulation Effects on Weight Change and Metabolic Rate
Official Title  ICMJE Effects of Deep Brain Stimulation of the Lateral Hypothalamic Area on Weight Change and Metabolic Rate
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE 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
Study Arms  ICMJE 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

Intervention: Device: Deep Brain Stimulation of the Lateral Hypothalamic Area
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2013)
3
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01933113
Other Study ID Numbers  ICMJE DBS 5583
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Donald M. Whiting, MD, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study Sponsor  ICMJE Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Donald M Whiting, MD West Penn Allegheny Health System
PRS Account Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP