Chronic PainNCT03998007
Development of a Medical Device Utilizing an EEG-Based Algorithm for the Objective Quantification of Pain
An observational study of Chronic Pain, run by PainQx, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- IRIS System
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2018to 22 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- Patients with cancer
- Patients on workers compensation or disability
- Patient on anticonvulsant medication
- Patients who have a history of seizures
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Pain Care Center
Waltham, Massachusetts, 02451
About this study
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
- Being tested
- IRIS System
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRIS SystemDevice
A QEEG based pain biomarker that scales with the patient reported NRS
What is being measured
The primary outcome is the main question the study is designed to answer.
Pearsons Correlation between IRIS derived pain biomarker and patient reported Numeric Rating Scale (0-10)
A Pearson Correlation of 1.0 is perfection correlation and 0 no correlation between the two measured variables
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start2 Oct 2018
- Primary completion22 Jan 2019
- Study completion22 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- PainQx, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- William Koppes, Principal investigator, PainQx, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998007
- Sponsor's protocol ID
- 00001
- Status last verified
- Jun 2019
- First submitted
- 21 Jun 2019
- Last updated
- 27 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Medical Device Utilizing an EEG-Based Algorithm for the Objective Quantification of Pain
- ClinicalTrials.gov ID
- NCT03998007
- Acronym / sponsor ID
- 00001
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- PainQx, IncIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 22 Jan 2019 (actual)
- Study completion
- 22 Jan 2019 (actual)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRIS SystemA QEEG based pain biomarker that scales with the patient reported NRS | Device | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Koppes principal investigator
PainQx, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by PainQx, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pearsons Correlation between IRIS derived pain biomarker and patient reported Numeric Rating Scale (0-10) (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2019.