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

NCT ID: NCT03998007

Last Updated: 2019-06-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-02
• Study Completion Date: 2019-01-22

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

IRIS System

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

PainQx, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Koppes

Role: PRINCIPAL_INVESTIGATOR

PainQx, Inc

Locations

Boston Pain Care Center

Waltham, Massachusetts, United States

Countries

United States

Other Identifiers

00001

Identifier Type: -

Identifier Source: org_study_id