Responsive Neurostimulation For Loss Of Control Eating (DBSLOC)

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University of Pennsylvania

Status

Enrolling

Conditions

Loss of Control Eating
Obesity, Morbid

Treatments

Device: responsive neurostimulation

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03868670
IRB-46563

Details and patient eligibility

About

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

Full 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

Enrollment

6 estimated patients

Sex

All

Ages

22 to 65 years old

Volunteers

No 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.

Trial design

6 participants in 1 patient group

Responsive Neurostimulation
Experimental group
Description:
Surgical arm. Patients expected to receive treatment.
Treatment:
Device: responsive neurostimulation

Trial contacts and locations

0

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Central trial contact

marie Kerr, ccrp; Nida Firdous, CRC

Data sourced from clinicaltrials.gov

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