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Responsive Neurostimulation For Loss Of Control Eating (DBSLOC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03868670
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : April 26, 2022
Sponsor:
Collaborator:
NeuroPace
Information provided by (Responsible Party):
Casey Halpern, Abramson Cancer Center at Penn Medicine

Study Description
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Brief Summary:
The primary objective of this trial is to assess device function and safety, with secondary objectives including the feasibility.

Condition or disease Intervention/treatment Phase
Loss of Control Eating Obesity, Morbid Device: responsive neurostimulation Not Applicable

Detailed Description:
This is a single site, early feasibility study to support development of a novel therapeutic approach for utilizing the NeuroPace RNS® System for nucleus accumbens responsive neurostimulation (NAc- RNS) to ameliorate loss of control over (LOC) eating in persons with treatment-refractory obesity, specifically those who have failed gastric bypass surgery. The primary objectives are to assess the safety & feasibility & potential efficacy of the medical device named the NeuroPace RNS® System
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Responsive Neurostimulation For Loss Of Control Eating
Actual Study Start Date : April 10, 2019
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 1, 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: Responsive Neurostimulation
Surgical arm. Patients expected to receive treatment.
 Device: responsive neurostimulation
The RNS® System is a novel, implantable therapeutic device that delivers responsive neurostimulation, an advanced technology designed to continuously monitor brain electrical activity, detect abnormal electrical activity and respond by delivering imperceptible levels of electrical stimulation to normalize that activity before an individual experiences seizures. This is an Early Feasibility Study determining the safety and efficacy of NAc-RNS in the treatment of LOC eating in treatment-refractory obesity.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Related Adverse Events [Safety and Tolerability] [ Time Frame: 5 years ]

    Safety of the RNS System and NAc stimulation through evaluation of AE's graded as "related" (vs. not related) to the intervention that will be graded based on severity.

    Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE


  2. Count of Participants Exhibiting Overall Decrease in Loss of Control Episodes Per Week [ Time Frame: 5 years ]
    This endpoint will be met if at least 50% of subjects exhibiting a decrease in the number of Loss of Control (LOC) episodes per week. LOC episodes will be assessed by the currently available standard, ecological momentary assessment (EMA) diary entries.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI 40-60 kg/m2
  • Failure of at least one weight loss medication
  • Previous Gastric Bypass Surgery lead to less than 50% of excess weight lost by 2 years after surgery
  • Significant Loss of Control over eating
  • Subject is able to attend all scheduled clinic appointments on their own or with a caregiver.
  • Premenopausal women must agree to use acceptable methods of birth control.
  • Participants provide voluntary, decisionally capable, and appropriately informed consent.
  • Subject is able to comply w/ all testing and follow-up requirements defined by the study protocol.
  • Participant has no immediate plan for relocation beyond 6 hours of the study site.
  • Proficiency with the English language.

Exclusion Criteria:

  • Subject has an implanted medical device that delivers electrical energy to the brain.
  • Subject has an implantable cardiac pacemaker, defibrillator, or neurostimulator.
  • Subject is likely to require repeat MR imaging after implant of the RNS Neurostimulator and Leads.
  • Subject is unable to fit into CT scanner (500lb upper weight limit for CT scanner).
  • Inability to provide informed consent to treatment.
Contacts and Locations
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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): NCT03868670


Contacts
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Contact: Nida Firdous, CRC 215-829-6720 nida.firdous@pennmedicine.upenn.edu
Contact: marie Kerr, ccrp 215-829-6720 marie.kerr@pennmedicine.upenn.edu

Locations
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United States, California
Stanford University Active, not recruiting
Stanford, California, United States, 94301
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Marie Kerr, CCRP    856-693-5914    marie.kerr@pennmedicine.upenn.edu   
Contact: Eileen Maloney-Wilensky, MSN, ACNP-BC    267-809-2525    eileen.maloney@pennmedicine.upenn.edu   
Principal Investigator: Casey Halpern, MD         
Sponsors and Collaborators
Casey Halpern
NeuroPace
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Casey Halpern, Assistant Professor of Neurosurgery, Chief of Stereotactic and Functional Neurosurgery, Abramson Cancer Center at Penn Medicine
ClinicalTrials.gov Identifier: NCT03868670    
Other Study ID Numbers: IRB-46563
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: April 26, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overweight
 Overnutrition
Nutrition Disorders
Body Weight