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

NCT04585451 | Completed Results DMC FDA Device

• 2 other identifiers: PQXNIH25R44DA046964-03
• Study Type: observational
• Target: 334
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Area Under the Curve of Classification Versus Patient Self Report of no/Mild Pain vs Moderate/Severe Pain State

  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

  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.

Study Arms (2)

Chronic Pain Patients

Diagnostic Test: ALGOS System

Healthy Controls

Diagnostic Test: ALGOS System

Interventions

ALGOS System DIAGNOSTIC_TEST

A Quantitative Electroencephalography (QEEG) based pain biomarker assessment that scales with patient reported Numeric Rating Scale (NRS)

Chronic Pain Patients; Healthy Controls

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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)
• 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

Sponsors & Collaborators

• PainQx, Inc: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (5)

Panorama Orthopedics & Spine Center

Golden, Colorado, 80401, United States

Location

Comprehensive Spine and Pain Center of New York

New Hyde Park, New York, 11042, United States

Location

Pain Management at Comprehensive Pain and Wellness Center

New York, New York, 10016, United States

Location

Comprehensive Spine and Pain Center of New York

New York, New York, 10017, United States

Location

Comprehensive Spine & Pain Center of New York

Valley Stream, New York, 11580, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: VP R&D
• Organization: PainQx

bd@painqx.com

6179817753

Study Officials

• William Koppes

  PainQx, Inc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 14, 2020
• Study Start: July 23, 2020
• Primary Completion: January 5, 2022
• Study Completion: January 5, 2022
• Last Updated: May 6, 2023
• Results First Posted: May 6, 2023

Record last verified: 2023-04

Locations

US (5)