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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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PainQx, with the support of the Department of Defense (Contract #W81XWH-21-C-0034), is conducting a study to collect electroencephalography (EEG) data from people with chronic pain in order to develop algorithms than will objectively assess the pain a person is experiencing. EEG is a monitoring method that records electrical activity in the brain. If enrolled in the study, subjects will be asked to answer a series of questions regarding their level of chronic pain, level of functionality, symptoms, behavioral health information, and medications, and subsequently have a 15 minute, non-invasive EEG recording taken by placing electrodes along the scalp. Through participation, chronic pain subjects will provide data needed to further develop this technology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic Pain Patients |
| ||
| Healthy Controls |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zeto WR19 EEG Recording | Device | 15 minutes of EEG recording to be obtained from eligible participants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pearsons Correlation between ALGOS derived pain biomarker and patient reported Defense and Veterans Pain Rating Scale (0-10) | Data analysis occurs within 3 months of study completion |
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Inclusion Criteria:
Exclusion Criteria:
• Patients with medically diagnosed psychotic illness, such as Schizophrenia
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 EEG data acquisition
Patients who have a spinal cord stimulator, neurological implants, deep brain stimulators, or other pain related implantable devices such as an intrathecal drug pump
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
o 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
o Note: This does not exclude patients who have been in complete remission for more than two years
Patients on workers compensation or disability or have other circumstances which may cause/incentive them to misreport their pain
Patient on gabapentin or pregabalin (within the last month)
Patients on experimental drugs (i.e. participating in drug trial), use off-label drugs, or are on unapproved dosages
Patients who have a history of seizures (within the past 3 months)
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A minimum of two hundred twenty-five (225) male and female chronic pain patients between the ages of 18-85 years will be enrolled in the study. A minimum of seventy-five (75) healthy normal subjects between the ages of 18-85 years will also be enrolled. The normal subjects are added to assure that the study spans the entire pain scale including those with a self-reported pain score of 0. Subjects who meet inclusion/exclusion criteria will be asked to participate and to provide informed consent. The study will enroll up to 350 patients.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Panorama Orthopedics & Spine Center | Golden | Colorado | 80401 | United States | ||
| Indiana Spine Group |
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| Carmel |
| Indiana |
| 46032 |
| United States |
| Comprehensive Spine and Pain Center of New York | New York | New York | 10017 | United States |
| Weill Cornell Medicine | New York | New York | 10065 | United States |
| Center for Interventional Pain and Spine | Lancaster | Pennsylvania | 17601 | United States |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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