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

Completed

Conditions studied: Chronic Pain

In brief

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.

Key facts

Study ID: NCT05215184
Run by: PainQx, Inc
People needed: 278
Starts: 2021-09-15
Expected to finish: 2022-08-30
Last updated by the study team: 2022-10-04

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Male and female chronic pain patients
Patients between the ages of 18-85 years
Patients exhibiting the presence of symptoms in excess of 3 months duration
Patients suffering from neuropathic (e.g., lower back pain), osteoarthritis, or muscular skeletal pain
Patients with evidence of pathology related to the painful condition on which diagnosis was made (e.g., results of imaging or diagnostic pain code)
Patients with NRS pain scores across the full range (0-10) at the time of testing

You may not qualify if…

• 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)

Where it is running

Panorama Orthopedics & Spine Center — Golden, Colorado, United States
Indiana Spine Group — Carmel, Indiana, United States
Comprehensive Spine and Pain Center of New York — New York, New York, United States
Weill Cornell Medicine — New York, New York, United States
Center for Interventional Pain and Spine — Lancaster, Pennsylvania, United States

Full record on ClinicalTrials.gov

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