Development of a Medical Device Utilizing an EEG-Based Algorithm for the Objective Quantification of Pain
Completed
Conditions studied: Chronic Pain
In brief
Obtained 19 lead EEG data from 50 chronic pain patients along with their clinical history and self-reported pain scored. Machine learning was used to analyze the EEG data and derive a chronic pain biomarker.
Key facts
- Study ID
- NCT03998007
- Run by
- PainQx, Inc
- People needed
- 50
- Starts
- 2018-10-02
- Expected to finish
- 2019-01-22
- Last updated by the study team
- 2019-06-27
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
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 (1-10) at the time of testing
You may not qualify if…
- 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
- Patients with cancer
- Patients on workers compensation or disability
- Patient on anticonvulsant medication
- Patients who have a history of seizures
Where it is running
- Boston Pain Care Center — Waltham, Massachusetts, United States
Full record on ClinicalTrials.gov
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