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

NCT05215184 | Completed DMC FDA Device

• 1 other identifier: Pro00054666
• Study Type: observational
• Target: 278
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

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

  Data analysis occurs within 3 months of study completion

Study Arms (2)

Chronic Pain Patients

Device: Zeto WR19 EEG Recording

Healthy Controls

Device: Zeto WR19 EEG Recording

Interventions

Zeto WR19 EEG Recording DEVICE

15 minutes of EEG recording to be obtained from eligible participants

Chronic Pain Patients; Healthy Controls

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• PainQx, Inc: lead
• United States Department of Defense: collaborator

Study Sites (5)

Panorama Orthopedics & Spine Center

Golden, Colorado, 80401, United States

Location

Indiana Spine Group

Carmel, Indiana, 46032, United States

Location

Comprehensive Spine and Pain Center of New York

New York, New York, 10017, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Center for Interventional Pain and Spine

Lancaster, Pennsylvania, 17601, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: January 31, 2022
• Study Start: September 15, 2021
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: October 4, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)