Expanded Development of a Medical Device Utilizing an EEG-Based Algorithm for the Objective Quantification of Pain

Exclusion Criteria

• •Patients with medically diagnosed psychotic illness
• •Patients with medically diagnosed drug or alcohol dependence in the past 12 months
• •Patients with a medical history of head injury with loss of consciousness and amnesia (within the last 2 years)
• •Patients with skull abnormalities that preclude the proper placement of the electrodes for the EEG data acquisition
• •Patients who have a spinal cord stimulator, or other implantable devices
• •Patients for whom the source of pain at the time of the evaluation is associated with: neurological disorders (multiple sclerosis, Parkinson, dementia), diabetes, migraines, or those with reflex / sympathetic dystrophy disorder/complex regional pain syndrome, fibromyalgia, or visceral pain
• •Note: This does not exclude patients who suffer from these disorders if the current source of pain is not due to the disorder. For example, patients with diabetes are NOT excluded, but patients whose pain at the time of the evaluation is a result of diabetic neuropathy are excluded. Similarly, patients with a history of migraines but for whom a migraine is not the current source of pain at the time of the evaluation are NOT excluded.
• •Patients with cancer
• •Patients on workers compensation or disability
• •Patient on anticonvulsant medication
• •Patients who have a history of seizures