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

CompletedNCT03998007
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Development of a Medical Device Utilizing an EEG-Based Algorithm for the Objective Quantification of Pain
Conditions
Interventions
  • Device: IRIS System
Sponsor
PainQx, Inc
Collaborators
National Institute on Drug Abuse (NIDA)
Start date
2018-10-02
Primary completion
2019-01-22
Sex
All
Age range
from 18 Years to 85 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03998007