Deep Brain Stimulation Effects on Weight Change and Metabolic Rate

NCT ID: NCT01933113

Last Updated: 2025-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-07-31

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 Although 3 subjects had undergone placement of the DBS electrode in the pilot study, one subject was withdrawn from this study due to a lead breakage and medical instability pertaining to an unrelated abdominal infection.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

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Deep Brain Stimulation of the Lateral Hypothalamic Area

Intervention Type: DEVICE

Deep Brain Stimulation of the Lateral Hypothalamic Area

Interventions

Deep Brain Stimulation of the Lateral Hypothalamic Area

Deep Brain Stimulation of the Lateral Hypothalamic Area

Intervention Type: DEVICE

Other Intervention Names

Devices used in this protocol: Medtronic Activa TM SC model # 37603; Medtronic DBS lead model # 3389; Medtronic Extension model # 37086-60

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

OTHER

Sponsor Role: lead

Responsible Party

donald whiting

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Donald M Whiting, MD

Role: PRINCIPAL_INVESTIGATOR

West Penn Allegheny Health System

Locations

Allegheny Health Network

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23560573 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30315980 (View on PubMed)

Other Identifiers

DBS 5583

Identifier Type: -

Identifier Source: org_study_id