Status:
COMPLETED
Defense Health Agency- Development of a Medical Device Utilizing an EEG-Based Algorithm for the Objective Quantification of Pain
Lead Sponsor:
PainQx, Inc
Collaborating Sponsors:
United States Department of Defense
Conditions:
Chronic Pain
Eligibility:
All Genders
18-85 years
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- • 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)
Key Trial Info
Start Date :
September 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 30 2022
Estimated Enrollment :
278 Patients enrolled
Trial Details
Trial ID
NCT05215184
Start Date
September 15 2021
End Date
August 30 2022
Last Update
October 4 2022
Active Locations (5)
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1
Panorama Orthopedics & Spine Center
Golden, Colorado, United States, 80401
2
Indiana Spine Group
Carmel, Indiana, United States, 46032
3
Comprehensive Spine and Pain Center of New York
New York, New York, United States, 10017
4
Weill Cornell Medicine
New York, New York, United States, 10065