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Trial record 6 of 61 for:    pain | First posted from 10/14/2020 to 10/20/2020

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

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ClinicalTrials.gov Identifier: NCT04585451
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : March 4, 2021
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
PainQx, Inc

Brief Summary:
PainQx is conducting a study to collect electroencephalography (EEG) data from 250 people with chronic pain and 50 healthy controls in order to develop algorithms that will objectively assess the level of pain a person is experiencing.

Condition or disease Intervention/treatment
Chronic Pain Diagnostic Test: ALGOS System

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Expanded Development of a Medical Device Utilizing an EEG-Based Algorithm for the Objective Quantification of Pain
Actual Study Start Date : July 23, 2020
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Group/Cohort Intervention/treatment
Chronic Pain Patients Diagnostic Test: ALGOS System
A Quantitative Electroencephalography (QEEG) based pain biomarker assessment that scales with patient reported Numeric Rating Scale (NRS)

Healthy Controls Diagnostic Test: ALGOS System
A Quantitative Electroencephalography (QEEG) based pain biomarker assessment that scales with patient reported Numeric Rating Scale (NRS)




Primary Outcome Measures :
  1. Pearsons Correlation between ALGOS derived pain biomarker and patient reported Numeric Rating Scale (0-10) [ Time Frame: 1 month post participant recruitment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Two hundred fifty (250) 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 will be enrolled in this phase of the study. Fifty (50) healthy normal subjects between the ages of 18-85 years will also be enrolled. The normal subjects are added to assure that the study spans the entire pain scale including those with an NRS of 0.
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 Inclusion Criteria, Normal (no-pain) Group

o Subjects will be included with no history of pain with a duration of greater than 3 months, and no report of pain at the time of testing (or within 3 months 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

Note: This does not exclude patients who suffer from these disorders if the current source of pain is not due to the disorder. For example, patients with diabetes are NOT excluded, but patients whose pain at the time of the evaluation is a result of diabetic neuropathy are excluded. Similarly, patients with a history of migraines but for whom a migraine is not the current source of pain at the time of the evaluation are NOT excluded.

  • 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): NCT04585451


Contacts
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Contact: Skylar Jacobs 6179827753 bd@painqx.com

Locations
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United States, Colorado
Panorama Orthopedics & Spine Center Recruiting
Golden, Colorado, United States, 80401
Contact: Raquel Phillips         
United States, New York
Comprehensive Spine and Pain Center of New York Recruiting
New Hyde Park, New York, United States, 11042
Contact: Tim Canty, MD         
Pain Management at Comprehensive Pain and Wellness Center Recruiting
New York, New York, United States, 10016
Contact: Daniel Hanono, MD         
Comprehensive Spine and Pain Center of New York Recruiting
New York, New York, United States, 10017
Contact: Tim Canty, MD         
Comprehensive Spine & Pain Center of New York Recruiting
Valley Stream, New York, United States, 11580
Contact: Tim Cantty         
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: NCT04585451    
Other Study ID Numbers: PQXNIH2
5R44DA046964-03 ( U.S. NIH Grant/Contract )
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021
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: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations