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 : March 26, 2020
|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.
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: Tricia Cunningham, MPHemail@example.com|
|Contact: Vyvian Ngo, MPHfirstname.lastname@example.org|
|United States, California|
|Stanford, California, United States, 94301|
|Contact: Tricia Cunningham, MPH 650-388-8675 email@example.com|
|Principal Investigator: Casey Halpern, MD|