Medical Policy

 

Subject: Physiologic Recording of Tremor using Accelerometer(s) and Gyroscope(s)
Document #: MED.00101 Publish Date:    04/25/2018
Status: Reviewed Last Review Date:    03/22/2018

Description/Scope

This document addresses a type of tremor analysis device that includes an accelerometer and a gyroscope.  These devices are proposed for use in diagnosing tremor and also in deep brain stimulation to guide adjustments to the neurostimulator settings.

For information on additional testing, see:

Position Statement

Investigational and Not Medically Necessary:

The use of FDA-approved accelerometer/motion analysis testing devices is considered investigational and not medically necessary for all applications, including, but not limited to, the evaluation of tremors.

Rationale

A German study conducted in two centers in 2004 compared the quantitative tremor analyses of two independent normal cohorts using very similar methods.  This study compared diagnostic findings with lab-specific normal values.  A significant reduction of tremor frequency under 1000 g weight load (greater than 1 Hz), and a lack of rhythmic EMG activity at the tremor frequency in 85-90% of the recordings were robust findings in both centers.  The authors concluded that differences in frequency and total power indicated that clinical findings depend on the recording conditions and that normative data needs to be established in order to standardize tremor analysis using accelerometer devices.  This study focused on the technical capability of the accelerometer device and not its clinical utility in the evaluation of tremor (Raethjen, 2004).  

The second small study conducted in the U.S. sought to determine the change in tremor amplitude that corresponds to a 1-point change in a typical 5-point Tremor Rating Scale (TRS) commonly used in the clinical assessment of tremor.  This study addressed the clinical validity of the accelerometer.  While the authors concluded that knowledge of the relationship between TRS and precise measures of tremor is useful in interpreting the clinical significance of changes in TRS produced by disease or therapy, this study did not address how this information could be used to improve treatment management (Elble, 2006).

In 2017, Zheng and colleagues published a study with the aim to use a smartwatch with a triaxial accelerometer, a smartphone, and a remote server to quantify tremor objectively during daily activities.  The study enrolled 9 subjects, with 1 subject’s data lost.  The remaining 8 subjects each had an average effective data collection time of 26 hours. Despite scattered data points, the authors calculated significant correlation between the subjects’ Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) self-assessment scores and the device (r=0.84, p<0.001); the device’s qualitative measurements and the subjects’ self-assessment scores (r=0.97, p=0.032); the device’s qualitative measurements and the neurologists’ standardized assessment scores (r=0.80, p=0.005); and the neurologists FTMTRS and subjects’ FTMTRS mean auto-assessment scores (r=0.84, p=0.009).  While this study had significant results, there were several limitations including small sample size, lack of control group, and complete collection of all data.  

A few small studies have investigated the clinical utility of accelerometric measurements for evaluation of tremor and functional ability in dyskinetic conditions, such as Parkinson’s disease and stroke.  The results, to date, have demonstrated inconsistent conclusions, and the authors acknowledge the need for further study to elucidate the clinical utility of these test devices and which population groups would potentially benefit from their use (Caligiuri, 2004; Cheung, 2011; Gebruers, 2010; Perez Lloret, 2010). 

Additional studies have investigated the clinical validity of accelerometric measurements to evaluate physical activity and gait variables in the elderly and in those with hip osteoarthritis using differing devices and methods of data analysis and reporting.  The authors acknowledged the need for further research to standardize testing methods and data reporting that compare devices in clinical practice (Bento, 2012; Item-Glatthorn, 2012).  Given the lack of studies on the clinical utility of accelerometers, the published evidence is insufficient to support the safety and efficacy of these devices, as compared to conventional testing modalities, at this time.

Background/Overview

There are multiple types of motion analysis accelerometers on the market for various applications including evaluation of physical exercise, weight reduction progress, and motion disorders, associated with certain conditions, such as Parkinson’s disease.  These devices attach to the individual's arm (or finger) to measure tremor.  Once attached, the person is then asked to do several tasks, such as resting with his hands in his lap for several seconds, holding his arms straight out in front of him for several seconds, and extending his arm and touching his nose.  Some models of these devices also include an electromyography (EMG) testing component.

One such device is the Kinesia (Cleveland Medical Devices, Inc., Cleveland, OH) which obtained clearance from the U.S. Food and Drug Administration (FDA) on April 6, 2007 through the 510(k) approval process.  The Kinesia device is indicated to:

The Kinesia device consists of a wrist module and ring sensor.  Motion sensors, including accelerometers and gyroscopes, are integrated into a finger-worn unit to capture three-dimensional motions.  The finger-worn sensor unit is connected to a wrist-worn module by a thin flexible wire.  The wrist module provides input for two channels of electromyography, battery power, onboard memory, and an embedded radio for real-time wireless transmission of the collected signals.  The signals are communicated between the wrist module and the computer unit using wireless technology based on 2.4-2.484 gigahertz (GHz) frequencies.  The wrist module includes a push button diary, so that the individual can indicate when he has taken his medication and when his symptoms are severe.

The Tremorometer® (FlexAble Systems, Inc., Fountain Hills, AZ) received 510(k) FDA clearance on July 25, 2001 and is described as a battery powered, hand-held, self-contained programmable device that includes a three-axis accelerometer that attaches to an individual’s finger and transmits tri-axial tremor measurements to a personal computer (PC) for further analysis, display, printing or storage.  According to updated FDA labeling, the Tremorometer is indicated:

To measure and record tri-axial readings of a patient’s tremor motions, to optionally combine the three axis tremor information into a single measurement of total tremor movement by a proprietary algorithm that eliminates some of the rotational orientation and other artifacts, to display the information graphically and to transfer the data to a PC for further analysis, display, printing or storage (FDA, 2012).

Definitions

Clinical utility: An assessment of the risks and benefits resulting from using a particular test and the likelihood that the test will lead to an improved overall outcome.

Clinical validity: The accuracy with which a test identifies or predicts an individual’s clinical status.

Kinematics: A branch of physics that deals with aspects of motion apart from considerations of mass and force.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:

CPT

 

95999

Unlisted neurological or neuromuscular diagnostic procedure [when specified as physiologic recording of tremor using accelerometer(s) and/or gyroscope(s) (including frequency and amplitude), including interpretation and report]

 

 

ICD-10 Diagnosis

 

 

All diagnoses

References

Peer Reviewed Publications:

  1. Bento T, Cortinhas A, Leitão JC, Mota MP. Use of accelerometry to measure physical activity in adults and the elderly. Rev Saude Publica. 2012; 46(3):561-570.
  2. Caligiuri MP, Tripp RM. A portable hand-held device for quantifying and standardizing tremor assessment. J Med Eng Technol. 2004; 28(6):254-262.
  3. Cheung VH, Gray L, Karunanithi M. Review of accelerometry for determining daily activity among elderly patients. Arch Phys Med Rehabil. 2011; 92(6):998-1014.
  4. Elble RJ. Gravitational artifact in accelerometric measurements of tremor. Clin Neurophysiol. 2005; 116(7):1638-1643.
  5. Elble RJ, Pullman SL, Matsumoto JY, et al. Tremor amplitude is logarithmically related to 4- and 5-point tremor rating scales. Department of Neurology, Southern Illinois University School of Medicine Springfield, IL. Department of Neurology, The Neurological Institute, Columbia University Medical Center, New York, NY. Department of Neurology, Mayo Clinic Rochester, MN. Neurological Institute, The Methodist Hospital Houston, TX. Department of Neurology, Christian-Albrechts-University Kiel, Germany. Brain. 2006; 129(10):2660-2666.
  6. Gebruers N, Vanroy C, Truijen S, et al. Monitoring of physical activity after stroke: a systematic review of accelerometry-based measures. Arch Phys Med Rehabil. 2010; 91(2):288-297.
  7. Giuffrida JP, Riley DE, Maddux BN, Heldman DA. Clinically deployable Kinesia technology for automated tremor assessment. Mov Disord. 2009; 24(5):723-730.
  8. Godfrey A, Conway R, Meagher D, O Laighin G. Direct measurement of human movement by accelerometry. Med Eng Phys. 2008; 30(10):1364-1386.
  9. Hoff JI, van den Plas AA, Wagemans EA, van Hilten JJ. Accelerometric assessment of levodopa-induced dyskinesias in Parkinson's disease. Mov Disord. 2001; 16(1):58-61.
  10. Hoff JI, van der Meer V, van Hilten JJ. Accuracy of objective ambulatory accelerometry in detecting motor complications in patients with Parkinson disease. Clin Neuropharmacol. 2004; 27(2):53-57.
  11. Item-Glatthorn JF, Casartelli NC, Petrich-Munzinger J, et al. Validity of the IDEEA accelerometry system for quantitative gait analysis in patients with hip osteoarthritis. Arch Phys Med Rehabil. 2012; 93(11):2090-2093.
  12. Kavanagh JJ, Menz HB. Accelerometry: a technique for quantifying movement patterns during walking. Gait Posture. 2008; 28(1):1-15.
  13. Keijsers NL, Horstink MW, Gielen SC. Automatic assessment of levodopa-induced dyskinesias in daily life by neural networks. Mov Disord. 2003; 18(1):70-80.
  14. Machowska-Majchrzak A, Pierzchała K, Pietraszek S. Analysis of selected parameters of tremor recorded by a biaxial accelerometer in patients with parkinsonian tremor, essential tremor and cerebellar tremor. Neurol Neurochir Pol. 2007; 41(3):241-250.
  15. Manson AJ, Brown P, O'Sullivan JD, et al. An ambulatory dyskinesia monitor. J Neurol Neurosurg Psychiatry. 2000; 68(2):196-201.
  16. Mansur PH, Cury LK, Andrade AO, et al. A review on techniques for tremor recording and quantification. Crit Rev Biomed Eng. 2007; 35(5):343-362.
  17. Mathie MJ, Coster AC, Lovell NH, et al. A pilot study of long-term monitoring of human movements in the home using accelerometry. J Telemed Telecare. 2004; 10(3):144-151.
  18. Milosevic M, Van de Vel A, Cuppens K, et al. Feature selection methods for accelerometry-based seizure detection in children. Med Biol Eng Comput. 2017; 55(1):151-165.
  19. Perez Lloret S, Rossi M, Cardinali DP, Merello M. Actigraphic evaluation of motor fluctuations in patients with Parkinson's disease. Int J Neurosci. 2010; 120(2):137-143.
  20. Raethjen J, Lauk M, Köster B, et al.  Department of Neurology, University of Kiel, (Kiel, Germany). Tremor analysis in two normal cohorts. Clin Neurophysiol. 2004; 115(9):2151-2156.
  21. Thielgen T, Foerster F, Fuchs G, et al. Tremor in Parkinson's disease: 24-hr monitoring with calibrated accelerometry. Electromyogr Clin Neurophysiol. 2004; 44(3):137-146.
  22. Verceles AC, Hager ER. Use of accelerometry to monitor physical activity in critically ill subjects: a systematic review. Respir Care. 2015; 60(9):1330-1336.
  23. Zheng X, Campos AV, Ordieres-Meré J, et al. Continuous monitoring of essential tremor using a portable system based on smartwatch. Front Neurol. 2017; 8(96). Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5350115/. Accessed on February 12, 2018.

Government Agency, Medical Society, and other Authoritative Publications:

  1. U.S. Food and Drug Administration (FDA). Center for Devices and Radiologic Health (CDRH). Kinesia (Cleveland Medical Devices, Inc., Cleveland, OH). K063872. April 6, 2007. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063872.pdf. Accessed on March 9, 2017.
  2. U.S. Food and Drug Administration (FDA). Center for Devices and Radiologic Health (CDRH). Tremorometer® (FlexAble Systems, Inc. Fountain Hills, AZ). K010270. July 25, 2001. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn_template.cfm?id=k010270. Accessed on March 9, 2017.
  3. Zesiewicz TA, Elble R, Louis ED, et al. Practice Parameter: Therapies for essential tremor (An Evidence-based Review). Report of the Quality Standards Subcommittee of the American Academy of Neurology (AAN). Neurology. 2005; 64:2008-2020. Available at: http://n.neurology.org/content/neurology/64/12/2008.full.pdf. Accessed on February 12, 2018.
  4. Zeuner KE, Shoge RO, Goldstein SR, et al. Accelerometry to distinguish psychogenic from essential or parkinsonian tremor. Human Motor Control Section, Medical Neurology Branch (Drs. Zeuner, Goldstein, and Hallett, and Shoge) and Biostatistics Branch (Dr. Dambrosia), National Institute of Neurological Disorders and Stroke, Bethesda, MD. Neurol. 2003; 61:548-550.
Websites for Additional Information
  1. Burke DA, Hauser RA, McClain T. Essential tremor. eMedicine Neurology. New York, NY: Medscape; updated November 27, 2017. Available at: http://emedicine.medscape.com/article/1150290-overview. Accessed on February 12, 2018.
  2. Chen JJ, Swope DM. Essential tremor: diagnosis and treatment. Pharmacotherapy. 2003; 23(9): 1105-1122. Published online January 16, 2012. Available at: http://onlinelibrary.wiley.com/doi/10.1592/phco.23.10.1105.32750/abstract. Accessed on February 12, 2018. 
  3. Product information available at the manufacturer’s web site for Gyroscope systems (Motus Bioengineering, Inc., Benicia, CA).  Available at: http://www.motusbioengineering.com/. Accessed on March 9, 2017.
Index

Accelerometer
Dyskinesia
Gyroscope
Kinesia
Motus Portable System
Movement Analysis
Tremor Analysis
Tremorometer

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.  

Document History

Status

Date

Action

Reviewed

03/22/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. The document header wording updated from “Current Effective Date” to “Publish Date.” Updated Rationale, Background, Definitions, References, and Websites sections.

Reviewed

05/04/2017

MPTAC review. References were updated.

Reviewed

05/05/2016

MPTAC review. The Background section and References were updated. Removed ICD-9 codes from Coding section.

Reviewed

05/07/2015

MPTAC review. References were updated.

 

01/01/2015

Updated Coding section with 01/01/2015 CPT changes; removed 0199T deleted 12/31/2014.

Reviewed

05/15/2014

MPTAC review. The Background section and References were updated.

Reviewed

05/09/2013

MPTAC review. The Rationale, Definitions and References were updated.

Reviewed

05/10/2012

MPTAC review. The Rationale and References were updated.

Reviewed

05/19/2011

MPTAC review. References were updated.

Reviewed

05/13/2010

MPTAC review. The Rationale and References were updated.

 

01/01/2010

Updated Coding section with 01/01/2010 CPT changes.

New

05/21/2009

MPTAC review. Initial document development.