Proceedings of the IEEE 27* Annual Northeast Bioengineering Conference

Induced Pain Inhibiting System (IPIS): New Technique to Manipulate Experimental Pain in Human Subject by Using Electrical Stimulation with Hexagonal Electrodes Ring Set
Hassan A. AI Marshad, BS, K. Francis Lee, MD, and John D. Enderle, PhD Baystate Health System, Department of Clinical Engineering, Springfield, MA Baystate Health System, Department of Surgery, Springfield, MA University of Connecticut, Department of Electrical and System Engineering, Storrs,CT
Abstract- Analgesic application of electrical stimulation during an induced pain on the medical research field is an unique technique. This study is about the development of Induced Pain Inhibiting System (IPIS) which consists of new electrodes set and LabVIE'Wn" waveform generation system to provide a new method for analgesic treatment during an induced pain and therefore could be used as alternative technique for pain inhibition in regional anesthetic treatment. I. Introduction In accordance with the basic electrophysiological conditions and as an improvement of the electrical stimulation use in regional anesthesia, ISIP system is designed to perform an optimum analgesic electrical stimulation. The system consists of electrodes and computer based electrical stimulator. Six electrodes on ring shape is designed, assembled, tested to be used with computer based electrical stimulator system. The study will evaluate: the variability of output parameters, electrode size, and stimulated tissue loads, the efficiency of those electrodes [2] and their suitability for electrical stimulation for the purpose of skin sense inhibition. An induced pain will be applied for 5 sec by needle and hotplate contacts. The stimulus response will be measured in the Visual Analogue and Graphic Rating Scales to provide more information about experimental pain [417[51. 1 . Objective 1 As an improvement of the electrical stimulation use in regional anesthesia, the study is directed to design and use Induced Pain Inhibiting System (ISIP) includes electrodes set which is designed as hexagonal ring in shape attached to laptop computer works as electrical simulator to generate desired waveforms for electrical stimulation. This prospective device and electrodes will be subjected to testing process for the purpose of making sure that the material, electrical properties, and performance standards used in this study are safe and effective for clinical use[l]. The success of such system will be followed by the second stage of the project which is the study on human subjects (after approval and consent). The target tissue under the experiment will be the area of the skin surface of the hand dorsum. Twenty healthy adults approximately 70 kg in mass will be subject to perform the experiment with the ISIP system, they will be exposed to noxious pain (heat, pinch, and pricking) where an induced heat and a pricking pain is applied at the same time with the electrical stimulation for the purpose of experimental induced pain measurement under ISIP system. The study intends to investigate and test pain thresholds, skin sensory, and pain idubitory effect. Pain will be induced and tested inside the electrodes ring, which will be placed on the dorsal hand. The measure of pain will be based on Mechanical Visual Analogue and Graphic Rating Scales. 111. Material & Methods Design of stimulus waveforms includes their characteristics for current-voltage output, and electrode's configuration, type, and size will be discussed in depth on this project.
Stimulus Waveform & output parameters Characteristics: The electrical stimulator is under the development using laptop computer with LabVIEWTM software and Virtual Instrumentation with appropriate NITM interface hardware (DAQPad-MIO- 16XE50, DAQCardAO-2DC) to generate, control, and record electrical stimulation with the following proprieties; impulse frequency 1-4 Hz,impulse duration selectable (0.1 ms - 1 ms), impulse amplitude (0.05-5 mA) exactly adjusted, adjustable constant current at resistance of 0.5-10 KOhm, monophasic square-wave initial hpulse, and high-quality connection cable and plug.

0-7803-6717-0/01/$10.0002001 IEEE

Proceedings of the IEEE 2 t Annual Northeast BioengineeringConference 7h

The ratio of peak voltage and peak current will be used and manipulated as an indicator of resistive tissue component [2],[3] and the ratio of phase charge and peak voltage will be used and manipulated as an indicator of the capacitive of tissue component.
Electrode size and .configurations: Electrode sue affects the stimulus parameters, comfort, and force generation associated with electrical stimulation [6]. By using six electrodes as hexagonal ring , this configuration allows to have total number of nine channels appropriated to the target tissue of the skin area under experiment. Fig 1

Signal Generaion, Cordml. (L Record: Compaq Laptop Computer. (L LabVlEWTM Software

Fig.2 Block diagram of ISIP System IV. Expected Results It is anticipated that the study goals and objectives will be achieved by designing and using ISIP system with appropriate stimulus waveforms and electrodes. In other words, it is llkely to be possible to inhibit the induced pain in order to have an altemative method to the current intravenous methods on regional anesthesia. Results of subsequent investigations on this study will lead to nonpharmacological manipulation of receptors and neurotransmitters involved in pain perception, recognition, modulation, and blockade with electricity.

Fig. 1. Hexagonal-ring set consists of six electrodes (three channels from electrical stimulator), thls unique polarity arrangement allows to have total number of nine channels.
Stimulated tissue loads: A combination of test loads with appropriate resistive and capacitive values is projected to account for stimulator design[l]. A simple resistor test load, 500 ohm, will be used to perform the device testing. Additionally, the AAMI standard [l] including the resistive capacitive load performance testing will be conducted before performing our experiment on humans. Engineering considerations and technical specifications of instrumentation associated with patient care standards will be implemented in all aspects of this study.

V. References [I] AAMVANSI Standard for TENS, NS4, 1985. [2] G. Kantor, and G. Alon, Transcutaneous Electrical Stimulation Devices Tests, 18* Annual Intemational Conference of the IEEE Engineering in Medicine and Biology Society, Amsterdam, 1996, SPS3: Special Session [3] G. Kantor, and Alon, G. , and H.S., Ho, Effects of selected stimulus waveforms on pulse and phase characteristics of sensory and motor thresholds, Physical Therapy, 1994, vol. 74, pp. 95 1-962 [4] D.D. Price, F.M. Bush, S. Long, and S.W. Harkins, A comparison of pain measurement characteristics of mechanical visual analogue and simple numerical rating scales, Pain, 56, 1994, pp. 217-226. [5] J. Scott, and , E.C. Huskisson, Graphic representation of pain, Pain, vol. 2, 1976, pp. 175-184. [6] G. Alon, G. Kantor, and S.H. Henry, Effects of Electrode S u e on Basic Excitatory Responses and on Selected Stimulus Parameters, JOSPT,ZO, 1994, pp. 29-35.