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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04585451
• Other study ID #: PQXNIH2
• Secondary ID: 5R44DA046964-03
• Status: Completed
• Start date: July 23, 2020
• Est. completion date: January 5, 2022

Study information

• Verified date: April 2023
• Source: PainQx, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: January 5, 2022
• Est. primary completion date: January 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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

Locations

Country	Name	City	State
United States	Panorama Orthopedics & Spine Center	Golden	Colorado
United States	Comprehensive Spine and Pain Center of New York	New Hyde Park	New York
United States	Comprehensive Spine and Pain Center of New York	New York	New York
United States	Pain Management at Comprehensive Pain and Wellness Center	New York	New York
United States	Comprehensive Spine & Pain Center of New York	Valley Stream	New York

Sponsors (2)

Lead Sponsor	Collaborator
PainQx, Inc	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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.
Primary	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)	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.
Primary	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)	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	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)	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	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)	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.