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«PacifiCare’s medical management guidelines represent the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. They are ...»

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Dystonia In a randomized, controlled trial (n=40), Kupsch, et al. compared deep brain stimulation with sham stimulation in patients with primary segmental or generalized dystonia. Three months after randomization, the change from baseline in the mean (+/-SD) movement score was significantly greater in the neurostimulation group (-15.8+/-14.1 points) than in the sham-stimulation group (points, P Vidailhet, et al. performed a prospective, controlled, multicenter study assessing the efficacy and safety of bilateral pallidal stimulation in 22 patients with primary generalized dystonia. The dystonia Deep Brain Stimulation- Commercial Medical Management Guideline movement score improved from a mean (+/-SD) of 46.3+/-21.3 before surgery to 21.0+/-14.1 at 12 months (P In a prospective, multicenter, double-blind, video-controlled study, Houeto, et al. evaluated 22 patients with primary generalized dystonia treated with pallidal DBS. Bilateral acute ventral stimulation of the GP significantly improved the Burke-Fahn-Marsden Dystonia Rating Scale score by 42% and resulted in stimulation of contacts located in the internal GP or medullary lamina in 18 of 21 patients. Bilateral acute dorsal pallidal stimulation, primarily localized within the external GP, had variable effects across patients, with half demonstrating slight or no improvement or even aggravation of dystonia compared with baseline. Ventral pallidal stimulation, primarily of the internal GP or medullary lamina or both, was found to be the optimal method for the treatment of dystonia in this patient group. (Houeto, 2007) The European Federation of Neurological Societies and the Movement Disorder Society-European Section (EFNS/MDS-ES) task force conducted a systematic literature review and published evidence-based recommendations for diagnosis and treatment of dystonia. Their recommendation regarding pallidal DBS states that DBS is "considered a good option for generalized and cervical dystonia" that is unresponsive to medication or botulinum toxin. DBS is considered second-line treatment for generalized dystonia but not for cervical dystonia. (Albanese, 2006) The National Institute for Health and Clinical Excellence (NICE) issued a guidance stating that the current evidence supports the safety and efficacy of DBS as a treatment modality for dystonia.

Dystonia may be treated conservatively or surgically. Conservative treatment only treats the symptoms, and surgical intervention (i.e., thalamotomy and pallidotomy) may not render long-term benefits. Patient selection and management should be managed by a multidisciplinary team specializing in the long-term care of patients with movement disorders. (NICE, 2006) Other Conditions Deep brain stimulation has been investigated for disorders such as major depression (Lozano, 2008), epilepsy (Afif, 2008), Tourette syndrome (Welter, 2008; Maciunas, 2007), cluster headache (Franzini, 2008), impulsive or violent behavior (Franzini, 2005), chronic pain and trigeminal neuralgica (Bittar, 2005; Coffey, 2006; Rasche, 2006), and movement disorders of multiple sclerosis (Hyam, 2007). While there is limited evidence to suggest that deep brain stimulation (DBS) may be an option for some of these conditions, there is not enough evidence to establish patient selection criteria and the safety and efficacy of DBS. Studies investigating DBS for treatment of other conditions are mainly case series with small sample sizes and short-term follow-up. Further welldesigned studies are needed to demonstrate the benefits of deep brain stimulation for these disorders.

Appleby et al. (2007) conducted a meta-analysis is to characterize the risks and benefits of DBS and to assess its possible use within the psychiatric setting. A total of 808 articles met inclusion criteria for the meta-analysis; 98.2% of studies that specifically assessed motor function reported some level

Deep Brain Stimulation- Commercial Medical Management Guideline

of improvement. Most reported side effects were device or procedure related (e.g., infection and lead fracture). The prevalence of depression was 2-4%, mania 0.9-1.7%, emotional changes 0.1-0.2%, and the prevalence of suicidal ideation/suicide attempt was 0.3-0.7%. The authors concluded that DBS is an effective treatment for Parkinson's disease, dystonia, and essential tremor, and case reports suggest that major depression and OCD may also respond to DBS. There is a need for further clinical studies to asses its efficacy and safety before it can be offered as routine care for psychiatric illnesses such as depression, OCD, and anxiety disorders.

In a 10-month, crossover, double-blind, multicenter study, 8 patients with highly refractory obsessive-compulsive disorder (OCD) were randomly assigned to undergo active stimulation of the subthalamic nucleus followed by sham stimulation and eight to undergo sham stimulation followed by active stimulation. The primary outcome measure was the severity of OCD, as assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), at the end of two 3-month periods. After active stimulation of the subthalamic nucleus, the Y-BOCS score (on a scale from 0 to 40, with lower scores indicating less severe symptoms) was significantly lower than the score after sham stimulation (P=0.01), and the Global Assessment of Functioning (GAF) score (on a scale from 1 to 90, with higher scores indicating higher levels of functioning) was significantly higher (P=0.005). The ratings of neuropsychological measures, depression, and anxiety were not modified by stimulation. There were 15 serious adverse events overall, including 1 intracerebral hemorrhage and 2 infections; there were also 23 non-serious adverse events. The investigators concluded that these preliminary findings suggest that stimulation of the subthalamic nucleus may reduce the symptoms of severe forms of OCD but is associated with a substantial risk of serious adverse events (Mallet et al., 2008) The effects of deep brain stimulation (DBS) for OCD were examined in four patients in a short-term, blinded, on-off design and long-term, open follow-up. The patients had incapacitating illness, refractory to standard treatments. Patients tolerated DBS well. Dramatic benefits to mood, anxiety, and OCD symptoms were seen in one patient during blinded study and open, long-term follow-up. A second patient showed moderate benefit during open follow-up. The investigators concluded that it appears that DBS has potential value for treating refractory psychiatric disorders, but additional development work is needed before the procedure is utilized outside of carefully controlled research protocols. (Abelson, 2005) Professional Societies





American Academy of Neurology - Parkinson's disease:

- DBS of the STN may be considered as a treatment option in PD patients to improve motor function and to reduce motor fluctuations, dyskinesia, and medication usage (Level C - possibly effective, ineffective, or harmful for the given condition in the specified population). Patients need to be counseled regarding the risks and benefits of this procedure. There is insufficient evidence to make any recommendations about the effectiveness of DBS of the GPi or VIM nucleus of the thalamus in reducing motor complications or medication usage, or in improving motor function in PD patients (Level U - data inadequate or conflicting given current knowledge, treatment is unproven).

Deep Brain Stimulation- Commercial Medical Management Guideline

- Preoperative response to levodopa should be considered as a factor predictive of outcome after DBS of the STN (Level B - probably effective, ineffective, or harmful for the given condition in the specified population). Age and duration of PD may be considered as factors predictive of outcome after DBS of the STN. Younger patients with shorter disease durations may possibly have improvement greater than that of older patients with longer disease durations (Level C). There is insufficient evidence to make any recommendations about factors predictive of improvement after DBS of the GPi or VIM nucleus of the thalamus in PD patients (Level U). (Pahwa, 2006)

American Academy of Neurology - Essential tremor:

- DBS of the VIM thalamic nucleus may be used to treat medically refractory limb tremor in ET (Level C - possibly effective, ineffective, or harmful for the given condition in the specified population).

- There is insufficient evidence to make recommendations regarding the use of thalamic DBS for head or voice tremor (Level U - data inadequate or conflicting given current knowledge, treatment is unproven).

- DBS has fewer adverse events than thalamotomy (Level B - probably effective, ineffective, or harmful for the given condition in the specified population). However, the decision to use either procedure depends on each patients circumstances and risk for intraoperative complications compared to feasibility of stimulator monitoring and adjustments. (Zesiewicz, 2005)

American Psychiatric Association:

Data regarding treatment of obsessive-compulsive disorder (OCD) with deep brain stimulation is limited and further research is needed. Two small, double-blind trials and several case reports have investigated the efficacy of DBS in OCD. Given the preliminary promising results in treatmentresistant OCD, the procedures reversibility and adjustability in comparison with ablative neurosurgery, and the absence to date of serious adverse events, DBS deserves investigation in severe, treatment-resistant OCD. Nonetheless, DBS is an invasive procedure, and the risks must be kept in mind. DBS should be considered only after first- and second-line treatments and wellsupported augmentation strategies have been exhausted. For the time being, DBS and ablative neurosurgical treatment for OCD should be performed only at sites with expertise in both OCD and these treatment approaches. (Koran, 2007) Additional Medical Products Activa® Tremor Control Therapy (Medtronic, Inc.) Activa® Parkinson's Control Therapy (Medtronic, Inc.) Activa® Dystonia Therapy (Medtronic, Inc.) Kinetra® neurostimulator (Medtronic, Inc.) Soletra® neurostimulator (Medtronic, Inc.) Additional Search Terms paroxysmal, myoclonic, myoclonus, paralysis agitans Deep Brain Stimulation- Commercial Medical Management Guideline References and Resources Resources Albanese A, Barnes MP, Bhatia KP, et al. A systematic review on the diagnosis and treatment of primary (idiopathic) dystonia and dystonia plus syndromes: report of an EFNS/MDS-ES Task Force.

Eur J Neurol. 2006 May;13(5):433-44.

Anderson VC, Burchiel KJ, Hogarth P, et al. Pallidal vs subthalamic nucleus deep brain stimulation in Parkinson disease. Arch Neurol. 2005 Apr;62(4):554-60.

Cif L, El Fertit H, Vayssiere N, et al. Treatment of dystonic syndromes by chronic electrical stimulation of the internal globus pallidus. J Neurosurg Sci. 2003 Mar;47(1):52-5.

Coubes P, Cif L, El Fertit H, et al. Electrical stimulation of the globus pallidus internus in patients with primary generalized dystonia: long-term results. J Neurosurg. 2004 Aug;101(2):189-94.

Deep brain stimulation for parkinson's disease study group. Deep brain stimulation of the subthalamic nucleus or the pars interna of the globus pallidus in Parkinson's disease. N Engl J Med.

2001;345(13):956-963.

Deuschl G, Schade-Brittinger C, Krack P, et al. A randomized trial of deep-brain stimulation for Parkinson's disease. N Engl J Med. 2006 Aug 31;355(9):896-908.

ECRI Institute. Deep Brain Stimulation for Pain Reduction. March 2008. Archived.

ECRI Institute. Deep Brain Stimulation for Parkinson's Disease and Essential Tremor. Updated 09/06. Archived.

ECRI Institute. Deep Brain Stimulation for Non Parkinsonian Neurologic and Psychiatric Disorders.

Updated 10/06. Archived.

ECRI Institute. Health Technology Forcast: Parkinson's Disease. September 2008.

ECRI Institute. Electrode Anchoring systems for Deep Brain Stimulation. Updated 04/29/04.

Archived.

ECRI Institute. Emerging Technology (TARGET) Evidence Report. Deep-brain stimulation for dystonia. February 2007.

Eltahawy HA, Saint-Cyr J, Giladi N, et al. Primary dystonia is more responsive than secondary dystonia to pallidal interventions: outcome after pallidotomy or pallidal deep brain stimulation.

Deep Brain Stimulation- Commercial Medical Management Guideline Neurosurgery. 2004;54(3):613-621.

Esselink RA, de Bie RM, de Haan RJ, et al. Unilateral pallidotomy versus bilateral subthalamic nucleus stimulation in PD: a randomized trial. Neurology. 2004 Jan 27;62(2):201-7.

Hariz MI, Krack P, Alesch F, et al. Multicentre European study of thalamic stimulation for Parkinsonian tremor; a 6-year follow-up. J Neurol Neurosurg Psychiatry. 2007 Sep 26 [Epub ahead of print].

Hayes Inc. Deep Brain Stimulation for Treatment of Dystonia. October 2004. Updated November 2008.

Hayes Inc. Deep Brain Stimulation for Parkinson's Disease and Essential Tremor. October 2004.

Updated October 2008.

Holloway KL, Baron MS, Brown R, et al. Deep brain stimulation for dystonia: a meta-analysis.

Neuromodulation. 2006; 9(4):253-261.

Horstink M, Tolosa E, Bonuccelli U, et al. Review of the therapeutic management of Parkinson's disease. Report of a joint task force of the European Federation of Neurological Societies (EFNS) and the Movement Disorder Society-European Section (MDS-ES). Part II: late (complicated) Parkinson's disease. Eur J Neurol. 2006 Nov;13(11):1186-202.

Houeto JL, Yelnik J, Bardinet E, et al. Acute deep-brain stimulation of the internal and external globus pallidus in primary dystonia: functional mapping of the pallidum. Arch Neurol. 2007 Sep;64(9):1281-6.

Hung SW, Hamani C, Lozano AM, et al. Long-term outcome of bilateral pallidal deep brain stimulation for primary cervical dystonia. Neurology. 2007 Feb 6;68(6):457-9.

Kenney C, Simpson R, Hunter C, et al. Short-term and long-term safety of deep brain stimulation in the treatment of movement disorders. J Neurosurg. 2007 Apr;106(4):621-5.

Kleiner-Fisman G, Herzog J, Fisman DN, et al. Subthalamic nucleus deep brain stimulation:

summary and meta-analysis of outcomes. Mov Disord. 2006 Jun;21 Suppl 14:S290-304.

Koran LM, Hanna GL, Hollander E, et al. Practice guideline for the treatment of patients with obsessive-compulsive disorder. Am J Psychiatry. 2007 Jul;164(7 Suppl):5-53.

Krause M, Fogel W, Kloss M, et al. Pallidal stimulation for dystonia. Neurosurgery. 2004 Dec;55(6):1361-8; discussion 1368-70.



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