Expanded 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 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Pain
What is being tested?: ALGOS System
How many people: 334 participants
Where: 5 sitesUnited States
Study dates: 23 Jul 2020to 5 Jan 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Healthy volunteers accepted
Adult, Older adult

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.

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 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)

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

Show all 11Show fewer

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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Panorama Orthopedics & Spine Center
Golden, Colorado, 80401
Comprehensive Spine and Pain Center of New York
New Hyde Park, New York, 11042
Pain Management at Comprehensive Pain and Wellness Center
New York, New York, 10016
Comprehensive Spine and Pain Center of New York
New York, New York, 10017
Comprehensive Spine & Pain Center of New York
Valley Stream, New York, 11580

Other trials in United States

About this study

Conditions: Chronic Pain
Being tested: ALGOS 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.

ALGOS SystemDiagnostic test
A Quantitative Electroencephalography (QEEG) based pain biomarker assessment that scales with patient reported Numeric Rating Scale (NRS)

Study groups in NCT04585451
Study group	Role	What they receive
Chronic Pain Patients		Not described Receives: Diagnostic Test: ALGOS System
Healthy Controls		Not described Receives: Diagnostic Test: ALGOS System

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Curve of Classification Versus Patient Self Report of Pain vs no Pain State
This measure is the performance of the classification of pain vs no pain compared to the patient self-report in the form of Numerical Rating Scale (NRS). The primary outcome measure is Area Under the Curve (AUC), derived from the Receiver Operating Characteristic (ROC) curve, a standard metric of performance for binary classifiers. AUC is a numeric quantity ranging from 0 to 1, where the value of 1 indicates perfect separation, while 0.5 represents zero separation. AUC represents a fundamental expression of classifier separation performance without the complexity of threshold selection. (NRS 0 vs 1-10)
Measured: Self-reported pain using average of NRS value at the start and end of EEG collection, and classification based on 15 minutes of EEG collection.
Sensitivity of Classification Versus Patient Self Report of Pain vs no Pain State
Sensitivity, or true positive rate is the probability of a positive result in the true chronic pain patients. This measure is calculated by dividing true positives by the summation of true positives and false negatives. (NRS 0 vs 1-10)
Measured: Self-reported pain using average of NRS value at the start and end of EEG collection, and classification based on 15 minutes of EEG collection.
Specificity of Classification Versus Patient Self Report of Pain vs no Pain State
Specificity, or true negative rate is the probability of a negative result in the true healthy control patients. This measure is calculated by dividing true negatives by the summation of true negatives and false positives. (NRS 0 vs 1-10)
Measured: Self-reported pain using average of NRS value at the start and end of EEG collection, and classification based on 15 minutes of EEG collection.

Secondary outcomes (2)

Area Under the Curve of Classification Versus Patient Self Report of no/Mild Pain vs Moderate/Severe Pain State
This measure is the performance of the classification of No/Mild vs Moderate/Severe pain compared to the patient self-report in the form of Numerical Rating Scale (NRS). The outcome measure is Area Under the Curve (AUC), derived from the Receiver Operating Characteristic (ROC) curve, a standard metric of performance for binary classifiers. AUC is a numeric quantity ranging from 0 to 1, where the value of 1 indicates perfect separation (the classifier is correct on every subject), while 0.5 represents zero separation (no better than guessing). AUC represents a fundamental expression of classifier separation performance without the complexity of threshold selection. (NRS 0-3.5 vs 4-10)
Measured: Self-reported pain using average of NRS value at the start and end of EEG collection, and classification based on 15 minutes of EEG collection.
Area Under the Curve of Classification Versus Patient Self Report of no, Mild, or Moderate Pain vs Severe Pain State
This measure is the performance of the classification of No/Mild/Moderate vs Severe pain compared to the patient self-report in the form of Numerical Rating Scale (NRS). The outcome measure is Area Under the Curve (AUC), derived from the Receiver Operating Characteristic (ROC) curve, a standard metric of performance for binary classifiers. AUC is a numeric quantity ranging from 0 to 1, where the value of 1 indicates perfect separation (the classifier is correct on every subject), while 0.5 represents zero separation (no better than guessing). AUC represents a fundamental expression of classifier separation performance without the complexity of threshold selection. (NRS 0-6.5 vs 7-10)
Measured: Self-reported pain using average of NRS value at the start and end of EEG collection, and classification based on 15 minutes of EEG collection.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jul 20205 Jan 2022

First posted14 Oct 2020
Study start23 Jul 2020
Primary completion5 Jan 2022
Study completion5 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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-control
Time perspective: Prospective
Enrolment: 334 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04585451
Sponsor's protocol ID: PQXNIH2
Other IDs: 5R44DA046964-03
Status last verified: Apr 2023
First submitted: 6 Oct 2020
Last updated: 6 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Expanded Development of a Medical Device Utilizing an EEG-Based Algorithm for the Objective Quantification of Pain
ClinicalTrials.gov ID: NCT04585451
Acronym / sponsor ID: PQXNIH2
Conditions: Chronic Pain
Study type: Observational
Recruitment status: Completed
Enrolment: 334 participants (actual)
Lead sponsor: PainQx, IncIndustry (pharma, biotech, devices)
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 23 Jul 2020 (actual)
Primary completion: 5 Jan 2022 (actual)
Study completion: 5 Jan 2022 (actual)
First posted: 14 Oct 2020 (actual)
Results: Posted 6 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Chronic Pain Patients	–	Diagnostic Test: ALGOS System
Healthy Controls	–	Diagnostic Test: ALGOS System

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (7 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 (11 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
ALGOS SystemA Quantitative Electroencephalography (QEEG) based pain biomarker assessment that scales with patient reported Numeric Rating Scale (NRS)	Diagnostic test	Chronic Pain Patients, Healthy Controls

Primary outcome

Area Under the Curve of Classification Versus Patient Self Report of Pain vs no Pain State
Time frame: Self-reported pain using average of NRS value at the start and end of EEG collection, and classification based on 15 minutes of EEG collection.
This measure is the performance of the classification of pain vs no pain compared to the patient self-report in the form of Numerical Rating Scale (NRS). The primary outcome measure is Area Under the Curve (AUC), derived from the Receiver Operating Characteristic (ROC) curve, a standard metric of performance for binary classifiers. AUC is a numeric quantity ranging from 0 to 1, where the value of 1 indicates perfect separation, while 0.5 represents zero separation. AUC represents a fundamental expression of classifier separation performance without the complexity of threshold selection. (NRS 0 vs 1-10)
Sensitivity of Classification Versus Patient Self Report of Pain vs no Pain State
Time frame: Self-reported pain using average of NRS value at the start and end of EEG collection, and classification based on 15 minutes of EEG collection.
Sensitivity, or true positive rate is the probability of a positive result in the true chronic pain patients. This measure is calculated by dividing true positives by the summation of true positives and false negatives. (NRS 0 vs 1-10)
Specificity of Classification Versus Patient Self Report of Pain vs no Pain State
Time frame: Self-reported pain using average of NRS value at the start and end of EEG collection, and classification based on 15 minutes of EEG collection.
Specificity, or true negative rate is the probability of a negative result in the true healthy control patients. This measure is calculated by dividing true negatives by the summation of true negatives and false positives. (NRS 0 vs 1-10)

2 secondary outcomes

Area Under the Curve of Classification Versus Patient Self Report of no/Mild Pain vs Moderate/Severe Pain State
Time frame: Self-reported pain using average of NRS value at the start and end of EEG collection, and classification based on 15 minutes of EEG collection.
Area Under the Curve of Classification Versus Patient Self Report of no, Mild, or Moderate Pain vs Severe Pain State
Time frame: Self-reported pain using average of NRS value at the start and end of EEG collection, and classification based on 15 minutes of EEG collection.

Results and safety

Results posted to the registry on 6 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Chronic Pain Patients	280	254
Healthy Controls	54	54

Primary outcome: Area Under the Curve of Classification Versus Patient Self Report of Pain vs no Pain State

Time frame: Self-reported pain using average of NRS value at the start and end of EEG collection, and classification based on 15 minutes of EEG collection.. Number. Unit: probability

Measure	Study Participants n = 308
Value	.70

Population analysed: Analysis was carried out using both arms combined: a control arm (negative class), and a pain arm (positive class). The reason for combining both arms is to assess the classifier's ability to differentiate the two classes and all outcome measures represent the performance of classification.

Primary outcome: Sensitivity of Classification Versus Patient Self Report of Pain vs no Pain State

Time frame: Self-reported pain using average of NRS value at the start and end of EEG collection, and classification based on 15 minutes of EEG collection.. Number. Unit: probability

Measure	Study Participants n = 308
Value	.783

Primary outcome: Specificity of Classification Versus Patient Self Report of Pain vs no Pain State

Time frame: Self-reported pain using average of NRS value at the start and end of EEG collection, and classification based on 15 minutes of EEG collection.. Number. Unit: probability

Measure	Study Participants n = 308
Value	.607

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year post recruitment. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Chronic Pain Patients	0 of 280 (0%)	0 of 280 (0%)	0 of 280
Healthy Controls	0 of 54 (0%)	0 of 54 (0%)	0 of 54

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

5 sites 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 5 sites 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 7 inclusion and 11 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

Yes. Results are posted in the registry (first posted 6 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Area Under the Curve of Classification Versus Patient Self Report of Pain vs no Pain State (time frame: Self-reported pain using average of NRS value at the start and end of EEG collection, and classification based on 15 minutes of EEG collection.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04585451.

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 6 May 2023.