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CompletedNCT05215184PQXDOD1Updated Oct 4, 2022

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

An observational study in Chronic Pain, sponsored by PainQx, Inc. Completed at 5 sites in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-04.

Sponsored by PainQx, Inc · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
278
Ages
18 Years to 85 Years
Sex
All
01

Study summary

PainQx, with the support of the Department of Defense (Contract #W81XWH-21-C-0034), is conducting a study to collect electroencephalography (EEG) data from people with chronic pain in order to develop algorithms than will objectively assess the pain a person is experiencing. EEG is a monitoring method that records electrical activity in the brain. If enrolled in the study, subjects will be asked to answer a series of questions regarding their level of chronic pain, level of functionality, symptoms, behavioral health information, and medications, and subsequently have a 15 minute, non-invasive EEG recording taken by placing electrodes along the scalp. Through participation, chronic pain subjects will provide data needed to further develop this technology.

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Conditions studied

  • Chronic Pain

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03

In context

Chronic Pain

2,999 studies on the registry are indexed under Chronic Pain; 706 are open to participants now.

This study's enrollment of 278 is above the median of 128 across 706 observational studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

PainQx, Inc is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

A minimum of two hundred twenty-five (225) male and female chronic pain patients between the ages of 18-85 years will be enrolled in the study. A minimum of seventy-five (75) 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 a self-reported pain score of 0. Subjects who meet inclusion/exclusion criteria will be asked to participate and to provide informed consent. The study will enroll up to 350 patients.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (0-10) at the time of testing

Exclusion criteria

Exclusion Criteria:

    • Patients with medically diagnosed psychotic illness, such as Schizophrenia

      • 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 EEG data acquisition
      • Patients who have a spinal cord stimulator, neurological implants, deep brain stimulators, or other pain related implantable devices such as an intrathecal drug pump

      • 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

        o 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

        o Note: This does not exclude patients who have been in complete remission for more than two years

      • Patients on workers compensation or disability or have other circumstances which may cause/incentive them to misreport their pain
      • Patient on gabapentin or pregabalin (within the last month)
      • Patients on experimental drugs (i.e. participating in drug trial), use off-label drugs, or are on unapproved dosages
      • Patients who have a history of seizures (within the past 3 months)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
278 participants (actual)
Patient registry
No

Groups and cohorts

  • Chronic Pain Patients

    Device: Zeto WR19 EEG Recording

  • Healthy Controls

    Device: Zeto WR19 EEG Recording

Interventions

  • DeviceZeto WR19 EEG Recording

    15 minutes of EEG recording to be obtained from eligible participants

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What researchers measure

Primary outcomes

  1. Pearsons Correlation between ALGOS derived pain biomarker and patient reported Defense and Veterans Pain Rating Scale (0-10)

    Time frame: Data analysis occurs within 3 months of study completion

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Study locations

5 sites
  • Panorama Orthopedics & Spine Center
    Golden, Colorado 80401, United States
  • Indiana Spine Group
    Carmel, Indiana 46032, United States
  • Comprehensive Spine and Pain Center of New York
    New York, New York 10017, United States
  • Weill Cornell Medicine
    New York, New York 10065, United States
  • Center for Interventional Pain and Spine
    Lancaster, Pennsylvania 17601, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2021 to primary completion in Aug 2022, 11 months.

Of 350 observational studies under Chronic Pain, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 51. This study's 11 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 17, 2022
First posted
Jan 31, 2022
StartActual
Sep 15, 2021
Primary completionActual
Aug 30, 2022
CompletionActual
Aug 30, 2022
Last update
Oct 4, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05215184
Lead sponsor
PainQx, Inc
Collaborators
United States Department of Defense
Responsible party
Sponsor
First posted
Jan 31, 2022
Start date
Sep 15, 2021
Primary completion
Aug 30, 2022
Completion
Aug 30, 2022
Last update
Oct 4, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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