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

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ClinicalTrials.gov Identifier: NCT03998007
Recruitment Status : Completed
First Posted : June 25, 2019
Last Update Posted : June 27, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Chronic Pain Device: IRIS System

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development of a Medical Device Utilizing an EEG-Based Algorithm for the Objective Quantification of Pain
Actual Study Start Date : October 2, 2018
Actual Primary Completion Date : January 22, 2019
Actual Study Completion Date : January 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain


Intervention Details:
  • Device: IRIS System
    A QEEG based pain biomarker that scales with the patient reported NRS


Primary Outcome Measures :
  1. Pearsons Correlation between IRIS derived pain biomarker and patient reported Numeric Rating Scale (0-10) [ Time Frame: 6 Months ]
    A Pearson Correlation of 1.0 is perfection correlation and 0 no correlation between the two measured variables



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03998007


Locations
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United States, Massachusetts
Boston Pain Care Center
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
PainQx, Inc
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: William Koppes PainQx, Inc

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Responsible Party: PainQx, Inc
ClinicalTrials.gov Identifier: NCT03998007     History of Changes
Other Study ID Numbers: 00001
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms