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

NCT03998007 | Completed

• 1 other identifier: 00001
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Obtained 19 lead EEG data from 50 chronic pain patients along with their clinical history and self-reported pain scored. Machine learning was used to analyze the EEG data and derive a chronic pain biomarker.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Pearsons Correlation between IRIS derived pain biomarker and patient reported Numeric Rating Scale (0-10)

  A Pearson Correlation of 1.0 is perfection correlation and 0 no correlation between the two measured variables

  6 Months

Interventions

IRIS System DEVICE

A QEEG based pain biomarker that scales with the patient reported NRS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Fifty (50) 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 were enrolled. Subjects who met the inclusion/exclusion criteria were asked to volunteer for the study.

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

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
• 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 (1)

Boston Pain Care Center

Waltham, Massachusetts, 02451, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• William Koppes

  PainQx, Inc

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: June 25, 2019
• Study Start: October 2, 2018
• Primary Completion: January 22, 2019
• Study Completion: January 22, 2019
• Last Updated: June 27, 2019

Record last verified: 2019-06

Locations

US (1)