NCT01933113

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 2, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

January 8, 2019

Completed
Last Updated

October 27, 2025

Status Verified

December 1, 2018

Enrollment Period

1.9 years

First QC Date

August 23, 2013

Results QC Date

October 10, 2017

Last Update Submit

September 29, 2025

Conditions

Obesity

Keywords

ObesityDeep Brain StimulationLHA

Outcome Measures

Primary Outcomes (1)

  • 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.

    One week of testing for each subject.

Study Arms (1)

DBS of the Lateral Hypothalamic Area

EXPERIMENTAL

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

Interventions

Deep Brain Stimulation of the Lateral Hypothalamic AreaDEVICE

Deep Brain Stimulation of the Lateral Hypothalamic Area

Also known as: Devices used in this protocol:, Medtronic Activa TM SC model # 37603, Medtronic DBS lead model # 3389, Medtronic Extension model # 37086-60
DBS of the Lateral Hypothalamic Area

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Prior placement of LHA DBS in accordance with previous study protocol

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States

Location

Related Publications (2)

  • 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.

    PMID: 23560573BACKGROUND

  • 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.

    PMID: 30315980BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Donald Whiting, MD
Organization
Allegheny Health Network
donald.whiting@ahn.org
412-359-6200

Study Officials

  • Donald M Whiting, MD

    West Penn Allegheny Health System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 23, 2013

First Posted

September 2, 2013

Study Start

August 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

October 27, 2025

Results First Posted

January 8, 2019

Record last verified: 2018-12

Locations

US(1)