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

Chronic Pain Clinical Trial

— PQXDOD1  

Official title:

Defense Health Agency- 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: NCT05215184
• Other study ID #: Pro00054666
• Status: Completed
• Start date: September 15, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: September 2022
• Source: PainQx, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 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 (0-10) at the time of testing

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)

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• Zeto WR19 EEG Recording
15 minutes of EEG recording to be obtained from eligible participants

Locations

Country	Name	City	State
United States	Indiana Spine Group	Carmel	Indiana
United States	Panorama Orthopedics & Spine Center	Golden	Colorado
United States	Center for Interventional Pain and Spine	Lancaster	Pennsylvania
United States	Comprehensive Spine and Pain Center of New York	New York	New York
United States	Weill Cornell Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
PainQx, Inc	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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