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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03998007

Enrollment

Registered

2019-06-25

Start date

2018-10-02

Completion date

2019-01-22

Last updated

2019-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

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.

Interventions

DEVICEIRIS System

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

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 * Patients with cancer * Patients on workers compensation or disability * Patient on anticonvulsant medication * Patients who have a history of seizures

Design outcomes

Primary

Measure	Time frame	Description
Pearsons Correlation between IRIS derived pain biomarker and patient reported Numeric Rating Scale (0-10)	6 Months	A Pearson Correlation of 1.0 is perfection correlation and 0 no correlation between the two measured variables

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026