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Deep Brain Stimulation Effects on Weight Change and Metabolic Rate

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Deep Brain Stimulation of the Lateral Hypothalamic Area
Sponsored by
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Deep Brain Stimulation, LHA

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Allegheny Health Network

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DBS of the Lateral Hypothalamic Area

Arm Description

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

Outcomes

Primary Outcome Measures

Change in Metabolic Rate
Metabolic rate of subjects will be measured while at Pennington Biomedical Research Center. Percentage of change in these parameters will be measured.

Secondary Outcome Measures

Full Information

First Posted
August 23, 2013
Last Updated
December 19, 2018
Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
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1. Study Identification

Unique Protocol Identification Number
NCT01933113
Brief Title
Deep Brain Stimulation Effects on Weight Change and Metabolic Rate
Official Title
Effects of Deep Brain Stimulation of the Lateral Hypothalamic Area on Weight Change and Metabolic Rate
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Deep Brain Stimulation, LHA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DBS of the Lateral Hypothalamic Area
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Deep Brain Stimulation of the Lateral Hypothalamic Area
Other Intervention Name(s)
Devices used in this protocol:, Medtronic Activa TM SC model # 37603, Medtronic DBS lead model # 3389, Medtronic Extension model # 37086-60
Intervention Description
Deep Brain Stimulation of the Lateral Hypothalamic Area
Primary Outcome Measure Information:
Title
Change in Metabolic Rate
Description
Metabolic rate of subjects will be measured while at Pennington Biomedical Research Center. Percentage of change in these parameters will be measured.
Time Frame
One week of testing for each subject.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald M Whiting, MD
Organizational Affiliation
West Penn Allegheny Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allegheny Health Network
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23560573
Citation
Whiting DM, Tomycz ND, Bailes J, de Jonge L, Lecoultre V, Wilent B, Alcindor D, Prostko ER, Cheng BC, Angle C, Cantella D, Whiting BB, Mizes JS, Finnis KW, Ravussin E, Oh MY. Lateral hypothalamic area deep brain stimulation for refractory obesity: a pilot study with preliminary data on safety, body weight, and energy metabolism. J Neurosurg. 2013 Jul;119(1):56-63. doi: 10.3171/2013.2.JNS12903. Epub 2013 Apr 5.
Results Reference
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PubMed Identifier
30315980
Citation
Whiting AC, Sutton EF, Walker CT, Godzik J, Catapano JS, Oh MY, Tomycz ND, Ravussin E, Whiting DM. Deep Brain Stimulation of the Hypothalamus Leads to Increased Metabolic Rate in Refractory Obesity. World Neurosurg. 2019 Jan;121:e867-e874. doi: 10.1016/j.wneu.2018.10.002. Epub 2018 Oct 11.
Results Reference
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Deep Brain Stimulation Effects on Weight Change and Metabolic Rate

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