A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS

Exclusion Criteria14

• Positive pregnancy test at screening, baseline, or at any point in the study.
• Evidence of active or recent unstable serious mental illness, including, psychosis, mania, severe depression, or suicidality.
• Moved to present residential placement in last three months or less.
• Likely move in residential placement during the course of the study.
• Cardiac abnormalities including medically documented history of cardiac disease or cardiac arrhythmia, documented resting heart rate ≤ 50 beats per minute (BPM); or history of 2° type 2 or 3° heart block on electrocardiogram (ECG).
• Evidence of clinically significant abnormalities of blood, liver, or kidney function from clinical safety laboratory assessments as determined by the Site Investigator.
• History of blood clot, pulmonary embolism, or deep vein thrombosis.
• Prior diagnosis of epilepsy or currently active seizures.
• Current enrollment in the active phase of different clinical trial or interventional study.
• Current use of hearing aids or implantable medical devices including implanted vagus nerve stimulation (iVNS) device, implanted cardiac pacemaker, implanted cardiac defibrillator, cochlear implants, cerebral shunt or cardiac implantable electrical devices.
• Presence of dermal abnormalities at the stimulation site that would interfere with the ability of the tVNS device to function properly.
• Presence of an allergy to titanium, titanium-iridium, thermoplastic elastomers, perfluoroethylene propylene, or polyurethane elastomers, or components of / preservatives present in the device electrode cream (Ceteareth-20, Propylene Glycol, Bentonite, Polysorbate 20, Phenoxyethanol, Ethylhexylglycerin).
• Severe, untreated sleep apnea, as self-reported by subject or caregiver or suspected by Site Investigator.
• Subject is, in the opinion of the Investigator, not suitable to participate in the study.