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Responsive Neurostimulation For Loss Of Control Eating (DBSLOC)

Primary Purpose

Loss of Control Eating, Obesity, Morbid

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
responsive neurostimulation
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Loss of Control Eating

Eligibility Criteria

22 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford University
  • University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Responsive Neurostimulation

Arm Description

Surgical arm. Patients expected to receive treatment.

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Related Adverse Events [Safety and Tolerability]
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
Count of Participants Exhibiting Overall Decrease in Loss of Control Episodes Per Week
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.

Secondary Outcome Measures

Full Information

First Posted
February 14, 2019
Last Updated
July 25, 2023
Sponsor
University of Pennsylvania
Collaborators
NeuroPace
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1. Study Identification

Unique Protocol Identification Number
NCT03868670
Brief Title
Responsive Neurostimulation For Loss Of Control Eating
Acronym
DBSLOC
Official Title
Responsive Neurostimulation For Loss Of Control Eating
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2019 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
NeuroPace

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Loss of Control Eating, Obesity, Morbid

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Responsive Neurostimulation
Arm Type
Experimental
Arm Description
Surgical arm. Patients expected to receive treatment.
Intervention Type
Device
Intervention Name(s)
responsive neurostimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Related Adverse Events [Safety and Tolerability]
Description
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
Time Frame
5 years
Title
Count of Participants Exhibiting Overall Decrease in Loss of Control Episodes Per Week
Description
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.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nida Firdous, CRC
Phone
215-829-6720
Email
nida.firdous@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
marie Kerr, ccrp
Phone
215-829-6720
Email
marie.kerr@pennmedicine.upenn.edu
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94301
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Kerr, CCRP
Phone
856-693-5914
Email
marie.kerr@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Eileen Maloney-Wilensky, MSN, ACNP-BC
Phone
267-809-2525
Email
eileen.maloney@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Casey Halpern, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36038628
Citation
Shivacharan RS, Rolle CE, Barbosa DAN, Cunningham TN, Feng A, Johnson ND, Safer DL, Bohon C, Keller C, Buch VP, Parker JJ, Azagury DE, Tass PA, Bhati MT, Malenka RC, Lock JD, Halpern CH. Pilot study of responsive nucleus accumbens deep brain stimulation for loss-of-control eating. Nat Med. 2022 Sep;28(9):1791-1796. doi: 10.1038/s41591-022-01941-w. Epub 2022 Aug 29.
Results Reference
derived

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Responsive Neurostimulation For Loss Of Control Eating

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