Responsive Neurostimulation For Loss Of Control Eating (DBSLOC)
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|ClinicalTrials.gov Identifier: NCT03868670|
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : April 26, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Loss of Control Eating Obesity, Morbid||Device: responsive neurostimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|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|
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.
- 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
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||22 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|Contact: Nida Firdous, CRCfirstname.lastname@example.org|
|Contact: marie Kerr, email@example.com|
|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 firstname.lastname@example.org|
|Contact: Eileen Maloney-Wilensky, MSN, ACNP-BC 267-809-2525 email@example.com|
|Principal Investigator: Casey Halpern, MD|
|Responsible Party:||Casey Halpern, Assistant Professor of Neurosurgery, Chief of Stereotactic and Functional Neurosurgery, Abramson Cancer Center at Penn Medicine|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|