Deep Brain Stimulation for the Treatment of Movement Disorders
DESCRIPTION
Deep brain stimulation (DBS) has been investigated as an alternative to permanent neuroablative procedures, such as thalamotomy and pallidotomy in the treatment of essential tremors and tremors associated with Parkinson’s disease (PD). There has been research interest in the use of DBS of the globus pallidus or subthalamic nucleus as a treatment of other Parkinsonian symptoms, such as rigidity, bradykinesia, or akinesia. A common morbidity associated with Parkinson's disease is the occurrence of motor fluctuations, referred to as "on and off" phenomena, related to the maximum effectiveness of drugs (i.e., the "on" state) and the nadir response during drug troughs (i.e., the "off" state). Levodopa, the most commonly used antiparkinson drug, may be associated with disabling drug-induced dyskinesias. Therefore, the optimal pharmacologic treatment of PD may involve a balance between optimal effects on Parkinson's symptoms versus the appearance of drug-induced dyskinesias. The effect of DBS on both Parkinson's symptoms and drug-induced dyskinesias has also been studied.
DBS has also been investigated in individuals with primary dystonia, defined as a neurological movement disorder characterized by involuntary muscle contractions, which force certain parts of the body into abnormal, contorted, and painful movements or postures. Dystonia can affect certain portions of the body (focal dystonia and multifocal dystonia) or the entire body (generalized dystonia). Torticollis is an example of a focal dystonia. Primary dystonia is defined when dystonia is the only symptom unassociated with other pathology. Treatment options for dystonia include oral or injectable medications (i.e., botulinum toxin) and destructive surgical or neurosurgical interventions (i.e., thalamotomies or pallidotomies) when conservative therapies fail.
DBS involves the stereotactic placement of an electrode into the brain (i.e., Vim nucleus of the thalamus, globus pallidus, or subthalamic nucleus). The electrode is typically implanted unilaterally on the side corresponding to the most severe symptoms. Bilateral stimulation with two electrode has also been investigated in individuals with bilateral, severe, symptoms. A temporary transcutaneous cable for short-term stimulation validates treatment effectiveness and is followed by surgery for permanent subcutaneous implantation of the cable and a programmable stimulator. After implantation, noninvasive programming of the neurostimulator can be adjusted to the individual's symptoms.
DBS has recently been investigated in patients with chronic cluster headaches, epilepsy, depression, obsessive compulsive disorder, and Tourette syndrome.
POLICY
Unilateral deep brain stimulation of the thalamus for the treatment of tremor is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below)
Unilateral or bilateral deep brain stimulation (simultaneous or staged) of the subthalamic nucleus or globus pallidus interna for the treatment of advanced Parkinson's disease is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below)
Unilateral or bilateral deep brain stimulation for the treatment of chronic, intractable primary dystonia is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below)
Deep brain stimulation for all other indications, including, but not limited to, other movement disorders (e.g., multiple sclerosis and posttraumatic dyskinesia), cluster headaches, psychiatric and/or neurologic disorders (e.g., Tourette syndrome, depression, obsessive compulsive disorder, and epilepsy) is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
MEDICAL APPROPRIATENESS
Deep brain stimulation (DBS) is considered medically appropriate if ALL of the following criteria are met:
The individual has ANY ONE of the following:
Unilateral DBS of the thalamus for the treatment of disabling unresponsive tremor for individuals with ANY ONE of the following
Essential tremor
Parkinson’s disease
Unilateral or bilateral DBS (simultaneous or staged) of the subthalamic nucleus or globus pallidus interna for the treatment of advanced Parkinson's disease if ALL of the following criteria are met:
A good response to carbidopa/levodopa
A minimal score of 30 points on the Unified Parkinson Disease Rating Scale when the individual has been without medication for approximately 12 hours (scores on this scale range from 0 to 108; higher values indicate greater severity of symptoms)
Motor complications that cannot be controlled by pharmacologic therapy
Unilateral or bilateral DBS for primary dystonia if ALL of the following criteria are met:
Greater than seven years of age
Chronic, intractable primary dystonia including generalized and/or segmental dystonia, hemidystonia and cervical dystonia (torticollis)
ABSENCE of ALL of the following contraindications:
Poor surgical risks because of unstable medical problems or because of the presence of a cardiac pacemaker
Medical conditions that require repeated magnetic resonance imaging (MRI)
Dementia that may interfere with the ability to cooperate
Botulinum toxin injections within the last 6 months
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Small studies of patients with cluster headaches have been reported but long term safety and efficacy has yet to be determined. There were no controlled studies of use of DBS in seizure disorders. Studies of DBS for depression and obsessive compulsive disorders involve small numbers of subjects and will need additional data on technical details and outcomes before establishing a therapeutic role for DBS in psychiatric applications.
SOURCES
American Academy of Neurology. (2005, February). Practice parameter: therapies for essential tremor: report of the quality standards subcommittee of the American Academy of Neurology. Retrieved December 21,2010 from http://www.neurology.org/content/64/12/2008.full.pdf+html.
BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2009). Deep brain stimulation (7.01.63). Retrieved December 16, 2010 from BlueWeb.
Complete Guide to Medicare Coverage Issues [Computer software]. (2008, November). Deep brain stimulation for essential tremor and Parkinson's disease (NCD 160.24, p. 2-77, 2-78). The Ingenix Complete Guide to Medicare Coverage Issues.
Deuschl, G., Schade-Brittinger, C., Krack, P., Volkmann, J., Schafer, H., Botzel, K., et al. (2006). A randomized trial of deep-brained stimulation for Parkinson’s disease. New England Journal of Medicine, 355 (9), 896 - 908. (Level 1 evidence - Industry sponsored)
ECRI Institute. Health Technology Information Service. Emerging Technology Evidence Report. (2010, September). Deep-brain stimulation for primary dystonia. Retrieved December 21, 2010 from ECRI Institute. (52 articles and/or guidelines reviewed)
ECRI Institute. Health Technology Information Service. Emerging Technology Evidence Report. (2010, August). Deep-brain stimulation for treatment resistant obsessive compulsive disorder. Retrieved December 21, 2010 from ECRI Institute.
Kuhn,J., Grundler, T., Lenartz, D., Sturm, V., Klosterkotter, J., & Huff, W. (2010) Deep brain stimulation of psychiatric disorders. Deutsches Ärzteblatt International 2010, 107 (7), 105-113. (Level 1 Evidence - Independent)
Kupsch, A., Benecke, R., Muller, J., Trottenberg, T., Schneider, G. H., Poewe, W., et al. (2006). Pallidal deep-brain stimulation in primary generalized or segmental dystonia. New England Journal of Medicine, 355 (19), 1978 - 1990. (Level 4 Evidence - Industry sponsored)
National Institute for Health and Clinical Excellence. (2003, November). Deep brain stimulation for Parkinson’s disease. Retrieved March 27, 2009 from http://www.nice.org.uk/nicemedia/live/11069/30859/30859.pdf.
National Institute for Health and Clinical Excellence. (2006, August). Deep brain stimulation for tremor and dystonia (excluding Parkinson’s disease). Retrieved March 26, 2009 from http://www.nice.org.uk/nicemedia/live/11219/31546/31546.pdf.
Porta, M., Sevello, D., Sassi, M., Brambilla, A., Defendi, S., Priori, A., et al. (2009) Issues related to deep brain stimulation for the treatment - refractory tourette’s syndrome. European Neurology, 62 (5), 264-273. (Level 1 Evidence - Independent)
U. S. Food and Drug Administration. (2003, April). Center for Devices and Radiological Health. Medtronic reclaim for obsessive compulsive disorder therapy - H050003. Retrieved December 27, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf5/H050003b.pdf.
U. S. Food and Drug Administration. (2009, February). Center for Devices and Radiological Health. Medtronic activa dystonia therapy - H020007. Retrieved April 27, 2007 from http://www.accessdata.fda.gov/cdrh_docs/pdf2/H020007a.pdf
Vidailhet, M., Vercueil, L., Houeto, J. L., Krystkowiak, P., Lagrange, C., Yelnik, J., et al. (2007). Bilateral, pallidal, deep-brain stimulation in primary generalized dystonia: a prospective 3 year follow-up study. Lancet Neurology, 6 (3), 223 - 229. (Level 4 Evidence - Industry sponsored)
ORIGINAL EFFECTIVE DATE: 3/1980
MOST RECENT REVIEW DATE: 5/14/2011
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