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出境医 / 临床实验 / Development of a Medical Device Utilizing an EEG-Based Algorithm for the Objective Quantification of Pain

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

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Chronic Pain Device: IRIS System

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development of a Medical Device Utilizing an EEG-Based Algorithm for the Objective Quantification of Pain
Actual Study Start Date : October 2, 2018
Actual Primary Completion Date : January 22, 2019
Actual Study Completion Date : January 22, 2019
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Pearsons Correlation between IRIS derived pain biomarker and patient reported Numeric Rating Scale (0-10) [ Time Frame: 6 Months ]
    A Pearson Correlation of 1.0 is perfection correlation and 0 no correlation between the two measured variables


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date June 21, 2019
First Posted Date June 25, 2019
Last Update Posted Date June 27, 2019
Actual Study Start Date October 2, 2018
Actual Primary Completion Date January 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 25, 2019) 		Pearsons Correlation between IRIS derived pain biomarker and patient reported Numeric Rating Scale (0-10) [ Time Frame: 6 Months ]
A Pearson Correlation of 1.0 is perfection correlation and 0 no correlation between the two measured variables
Original Primary Outcome Measures
 (submitted: June 24, 2019) 		Pearsons Correlation between IRIS derived pain biomarker and patient reported NRS pain score [ Time Frame: 6 Months ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Development of a Medical Device Utilizing an EEG-Based Algorithm for the Objective Quantification of Pain
Official Title Development of a Medical Device Utilizing an EEG-Based Algorithm for the Objective Quantification of Pain
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Fifty (50) male and female pain patients with symptoms in excess of 3 months duration (per the IASP definition of Chronic Pain) between the ages of 18-85 years were enrolled. Subjects who met the inclusion/exclusion criteria were asked to volunteer for the study.
Condition Chronic Pain
Intervention Device: IRIS System
A QEEG based pain biomarker that scales with the patient reported NRS
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 24, 2019) 		50
Original Actual Enrollment Same as current
Actual Study Completion Date January 22, 2019
Actual Primary Completion Date January 22, 2019   (Final data collection date for primary outcome measure)
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

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
  • Patients with cancer
  • Patients on workers compensation or disability
  • Patient on anticonvulsant medication
  • Patients who have a history of seizures
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03998007
Other Study ID Numbers 00001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party PainQx, Inc
Study Sponsor PainQx, Inc
Collaborators National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: William Koppes PainQx, Inc
PRS Account PainQx, Inc
Verification Date June 2019

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