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

Completed

• Conditions: Chronic Pain

• Registration Number: NCT03998007
• Lead Sponsor: PainQx, Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-02
• Primary Completion: 2019-01-22
• Study Completion: 2019-01-22
• Status Verified: 2019-06
• Study First Submitted: 2019-06-21
• Study First Submitted QC: 2019-06-24
• Study First Posted: 2019-06-25
• Last Update Submitted: 2019-06-25
• Last Update Posted: 2019-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Boston Pain Care Center; 🇺🇸 Waltham, Massachusetts, United States