N/A N=334

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

Chronic Pain

Bottom Line

View on ClinicalTrials.gov: NCT04585451 ↗

Enrolled (actual)

334

Serious AEs

0.0%

Results posted

May 2023

Primary outcome: Primary: Area Under the Curve of Classification Versus Patient Self Report of Pain vs no Pain State — .70 probability

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: ALGOS System (Diagnostic_test)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: PainQx, Inc
Primary completion: Jan 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Curve of Classification Versus Patient Self Report of Pain vs no Pain State	.70	—
PRIMARY Sensitivity of Classification Versus Patient Self Report of Pain vs no Pain State	.783	—
PRIMARY Specificity of Classification Versus Patient Self Report of Pain vs no Pain State	.607	—
SECONDARY Area Under the Curve of Classification Versus Patient Self Report of no/Mild Pain vs Moderate/Severe Pain State	.694	—
SECONDARY Area Under the Curve of Classification Versus Patient Self Report of no, Mild, or Moderate Pain vs Severe Pain State	.669	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04585451). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.