Apparatus and method for human algometry

• US 9,326,725 B2
• Filed: 03/30/2011
• Issued: 05/03/2016
• Est. Priority Date: 03/30/2010
• Status: Active Grant

• Current Assignee: Children's National Medical Center
• Original Assignee: Children's National Medical Center
• Inventors: Finkel, Julia C., Quezado, Zenaide M. N.
• Primary Examiner(s): Berhanu, Etsub
• Assistant Examiner(s): TOTH, KAREN E
• Application Number:
  US13/076,239
• Publication Number:
  US 20110245708A1
• Time in Patent Office: 1,861 Days
• Field of Search: 600544-545
• US Class Current: 1/1
• CPC Class Codes: A61B 5/377 using evoked responses
• CPC Class Codes: A61B 5/383 Somatosensory stimuli, e.g. electric stimulation
• CPC Class Codes: A61B 5/4824 Touch or pain perception evaluation A61B5/4821 takes precedence
• CPC Class Codes: A61B 5/4827 assessing touch sensitivity, e.g. for evaluation of pain threshold
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61N 1/36071 Pain

Abstract

An apparatus and method for performing human algometry are disclosed. They include a stimulator configured to apply electrical stimulation of variable intensity to an area of a patient'"'"'s body, a monitoring device configured to measure a level of cortical activity in one or more regions of the patient'"'"'s brain, and a microprocessor connected to the stimulator and the monitoring device that is configured to correlate the intensity of the electrical stimulation with the level of activity in the one or more regions of the patient'"'"'s brain and to determine at least one of a measurement of pain intensity, a measurement of a sensory detection threshold (SDT), a measurement of a drug'"'"'s analgesic impact, an indication of an onset of tolerance to a drug, an indication of an onset of analgesic-induced hyperalgesia, an indication of conditions of allodynia, a measurement of dose-response characteristics of pain management drugs, and a characterization of a pain condition.

Claims

1. A system for objectively measuring pain comprising:

a stimulator configured to apply electrical stimulation of variable intensity to an area of a patient'"'"'s body;

a monitoring device configured to measure a level of cortical activity at a plurality of different regions of the patient'"'"'s brain including a primary somatosensory cortex and a dorsolateral prefrontal cortex; and

a microprocessor connected to the stimulator and the monitoring device that is configured to

correlate a first level of cortical activity at the primary somatosensory cortex of the plurality of different regions of the patient'"'"'s brain with a second level of cortical activity at the dorsolateral prefrontal cortex of the plurality of different regions of the patient'"'"'s brain to determine the relationship between an emotional component of pain and a nociceptive component of pain and remove the emotional component to derive an activity measurement value, and

correlate the variable intensity of the electrical stimulation with the activity measurement value to determine, based on the correlation, an objective pain representation,

wherein the system further includes;

a pharmacologic-dispensing device that administers pain intervention drugs to the patient in accordance with the determined objective pain representation.

2. The system of claim 1, wherein the stimulator is configured to incrementally increase the intensity of the electrical stimulation until a sensory detection threshold (SDT) level of cortical activity is measured by the monitoring device.

3. The system of claim 1, wherein the stimulator is further configured to apply electrical stimulation to sensory nerve fibers by applying electrical stimulation at a first frequency in order to generate an action potential in Aβ

fibers, a second frequency in order to generate an action potential in Aδ

fibers, and a third frequency in order to generate an action potential in C fibers.

4. The system of claim 1, wherein the monitoring device utilizes at least one of near infrared spectroscopy (NIRS), electroencephalography (EEG), functional Magnetic Resonance imaging (fMRI), and near infrared imaging (NIRI) to measure the level of cortical activity in the plurality of different regions of the patient'"'"'s brain.

5. The system of claim 4, wherein the monitoring device utilizes NIRS and a NIRS sensor with emitters and detectors to measure the level of cortical activity in plurality of different regions of the patient'"'"'s brain.

6. The system of claim 4, wherein the monitoring device utilizes EEG with electrodes as sensors or EEG and NIRS with a combination of electrodes and at least one NIRS sensor as the sensors to measure the level of cortical activity in the plurality of different regions of the patient'"'"'s brain.

7. The system of claim 1, wherein the microprocessor is further configured to

accumulate a plurality of measurements of different levels of cortical activity in one or more regions of a plurality of first patients'"'"' brains in response to noxious and sub-noxious stimuli with different parameters, the noxious stimuli being applied prior to the sub-noxious stimuli and/or as part of one or more clinical trials;

correlate the plurality of measurements with a plurality of quantitative values in a pain intensity scale, the quantitative values representing a pain intensity measurement;

store the plurality of measurements, their corresponding quantitative values, and the parameters of the corresponding noxious and sub-noxious stimuli in a data library; and

assign one of the quantitative values to a second patient based on a measurement of the level of cortical activity in one or more regions of the second patient'"'"'s brain, the one quantitative value assigned to the second patient corresponding to a measurement in the data library that is closest to the measurement of the level of cortical activity in the one or more regions of the second patient'"'"'s brain.