Responsive Neurostimulation For Loss Of Control Eating (NCT03868670) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Responsive Neurostimulation For Loss Of Control Eating
United States6 participantsStarted 2019-04-10
Plain-language summary
The primary objective of this trial is to assess device function and safety, with secondary objectives including the feasibility.
Who can participate
Age range22 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* BMI 35-60 kg/m2
* Failure of at least one pharmacological agent intended for weight loss or binge eating disorder (select glucagon-like-peptide 1 \[GLP-1\] receptor agonists for the treatment of type 2 diabetes, which induce clinically meaningful weight loss \[i.e., \>2% baseline weight\], qualify as agents intended for weight loss, as do glucose-dependent insulinotropic polypeptide \[GIP\]/GLP-1 agonists)
* Failure of at least one form of behavioral therapy, such as weight loss therapy and cognitive behavioral therapy (minimum cumulative trial of 6 months)
* Failure of gastric bypass surgery or sleeve gastrectomy surgery
* Assessment by the study site's bariatric surgeon to rule out technical explanations for suboptimal outcome with an upper GI series within 6 months prior to consent (i.e. a pre-study referral assessment) or prior to surgery during the screening phase.
* Presence of LOC over eating (≥4 LOC episodes per week or ≥16 episodes per month (i.e. 28 days)), as reported on the ELOCS or the EDE interview
* Any medical (including psychiatric) conditions must be monitored actively by appropriate discipline and stable for the past 6 months. Related therapies or medications should be held stable for the study duration.
* Surgical suitability confirmed by a psychiatric examination.
* Subject is able to attend all scheduled clinic appointments on their own or with a caregiver.
* Subject is willing and able to complete signaled EMA assessments.
* Adequ…
What they're measuring
1
Incidence of Treatment-Emergent Related Adverse Events [Safety and Tolerability]
Timeframe: 5 years
2
Count of Participants Exhibiting Overall Decrease in Loss of Control Episodes Per Week