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

Completed

Conditions studied: Chronic Pain

In brief

PainQx is conducting a study to collect electroencephalography (EEG) data from 250 people with chronic pain and 50 healthy controls in order to develop algorithms that will objectively assess the level of pain a person is experiencing.

Key facts

Study ID

NCT04585451

Run by

PainQx, Inc

People needed

334

Starts

2020-07-23

Expected to finish

2022-01-05

Last updated by the study team

2023-05-06

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 (1-10) at the time of testing Inclusion Criteria, Normal (no-pain) Group
• o Subjects will be included with no history of pain with a duration of greater than 3 months, and no report of pain at the time of testing (or within 3 months of testing)

You may not qualify if…

• 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

Where it is running

• Panorama Orthopedics & Spine Center — Golden, Colorado, United States
• Comprehensive Spine and Pain Center of New York — New Hyde Park, New York, United States
• Pain Management at Comprehensive Pain and Wellness Center — New York, New York, United States
• Comprehensive Spine and Pain Center of New York — New York, New York, United States
• Comprehensive Spine & Pain Center of New York — Valley Stream, New York, United States

Full record on ClinicalTrials.gov

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