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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Diagnostic test: ALGOS System

• Study Type: Observational
• Enrollment (Actual): 334

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Golden, Colorado, United States, 80401
      • Panorama Orthopedics & Spine Center
  • New York
    • New Hyde Park, New York, United States, 11042
      • Comprehensive Spine and Pain Center of New York
    • New York, New York, United States, 10016
      • Pain Management at Comprehensive Pain and Wellness Center
    • New York, New York, United States, 10017
      • Comprehensive Spine and Pain Center of New York
    • Valley Stream, New York, United States, 11580
      • Comprehensive Spine & Pain Center of New York

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Two hundred fifty (250) male and female pain patients with symptoms in excess of 3 months duration (per the IASP definition of Chronic Pain) between the ages of 18-85 years will be enrolled in this phase of the study. Fifty (50) 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 an NRS of 0.

Description

Inclusion Criteria:

• 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)

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Controls	Diagnostic test: ALGOS System; A Quantitative Electroencephalography (QEEG) based pain biomarker assessment that scales with patient reported Numeric Rating Scale (NRS)
Chronic Pain Patients	Diagnostic test: ALGOS System; A Quantitative Electroencephalography (QEEG) based pain biomarker assessment that scales with patient reported Numeric Rating Scale (NRS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve of Classification Versus Patient Self Report of Pain vs no Pain State	This measure is the performance of the classification of pain vs no pain compared to the patient self-report in the form of Numerical Rating Scale (NRS). The primary outcome measure is Area Under the Curve (AUC), derived from the Receiver Operating Characteristic (ROC) curve, a standard metric of performance for binary classifiers. AUC is a numeric quantity ranging from 0 to 1, where the value of 1 indicates perfect separation, while 0.5 represents zero separation. AUC represents a fundamental expression of classifier separation performance without the complexity of threshold selection. (NRS 0 vs 1-10)	Self-reported pain using average of NRS value at the start and end of EEG collection, and classification based on 15 minutes of EEG collection.
Sensitivity of Classification Versus Patient Self Report of Pain vs no Pain State	Sensitivity, or true positive rate is the probability of a positive result in the true chronic pain patients. This measure is calculated by dividing true positives by the summation of true positives and false negatives. (NRS 0 vs 1-10)	Self-reported pain using average of NRS value at the start and end of EEG collection, and classification based on 15 minutes of EEG collection.
Specificity of Classification Versus Patient Self Report of Pain vs no Pain State	Specificity, or true negative rate is the probability of a negative result in the true healthy control patients. This measure is calculated by dividing true negatives by the summation of true negatives and false positives. (NRS 0 vs 1-10)	Self-reported pain using average of NRS value at the start and end of EEG collection, and classification based on 15 minutes of EEG collection.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve of Classification Versus Patient Self Report of no/Mild Pain vs Moderate/Severe Pain State	This measure is the performance of the classification of No/Mild vs Moderate/Severe pain compared to the patient self-report in the form of Numerical Rating Scale (NRS). The outcome measure is Area Under the Curve (AUC), derived from the Receiver Operating Characteristic (ROC) curve, a standard metric of performance for binary classifiers. AUC is a numeric quantity ranging from 0 to 1, where the value of 1 indicates perfect separation (the classifier is correct on every subject), while 0.5 represents zero separation (no better than guessing). AUC represents a fundamental expression of classifier separation performance without the complexity of threshold selection. (NRS 0-3.5 vs 4-10)	Self-reported pain using average of NRS value at the start and end of EEG collection, and classification based on 15 minutes of EEG collection.
Area Under the Curve of Classification Versus Patient Self Report of no, Mild, or Moderate Pain vs Severe Pain State	This measure is the performance of the classification of No/Mild/Moderate vs Severe pain compared to the patient self-report in the form of Numerical Rating Scale (NRS). The outcome measure is Area Under the Curve (AUC), derived from the Receiver Operating Characteristic (ROC) curve, a standard metric of performance for binary classifiers. AUC is a numeric quantity ranging from 0 to 1, where the value of 1 indicates perfect separation (the classifier is correct on every subject), while 0.5 represents zero separation (no better than guessing). AUC represents a fundamental expression of classifier separation performance without the complexity of threshold selection. (NRS 0-6.5 vs 7-10)	Self-reported pain using average of NRS value at the start and end of EEG collection, and classification based on 15 minutes of EEG collection.

Collaborators and Investigators

• Sponsor: PainQx, Inc
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2020
• Primary Completion (Actual): January 5, 2022
• Study Completion (Actual): January 5, 2022

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: PQXNIH2; 5R44DA046964-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes