Deep Brain Stimulation for Parkinson s Disease & Essential Tremor

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1 Deep Brain Stimulation for Parkinson s Disease & Essential Tremor Albert Fenoy, MD Assistant Professor University of Texas at Houston, Health Science Center

2 Current US Approvals Essential Tremor and Parkinsonian Tremor Indicated for unilateral thalamic stimulation of the ventral intermediate nucleus (VIM) for the suppression of tremor in the upper extremity in patients diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where tremor constitutes a significant functional disability. Parkinson s Disease ,000+ patients worldwide have received Medtronic DBS Therapy Indicated for bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson s disease that are not adequately controlled with medication Primary Dystonia HDE Indicated for unilateral or bilateral stimulation of the GPi or the STN as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in patients seven years of age and older. Obsessive Compulsive Disorder HDE

3 Essential Tremor

4 Essential Tremor Non-Life threatening disorder

5 Essential Tremor Non-Life threatening disorder Progressively worsens over time

6 Essential Tremor Non-Life threatening disorder Progressively worsens over time Severe Effect on Quality of Life

7 Essential Tremor Multidimensional Impacts are Disabling - Social - Professional - Emotional frustration, embarrassment

8 Why Surgery?

9 Why Surgery? Tremor Refractory to Medicine

10 Why Surgery? Tremor Refractory to Medicine Side effects of Medication intolerable

11 Why Surgery? Tremor Refractory to Medicine Side effects of Medication intolerable Severe tremor jeopardizes job and quality of life

12 DBS: VIM target

13 Outcome Unilateral or Bilateral: Significant relief of upper / lower extremity tremor

14 Outcome Unilateral or Bilateral: Significant relief of upper / lower extremity tremor Average Improvement 70%-90%

15 Outcome Unilateral or Bilateral: Significant relief of upper / lower extremity tremor Average Improvement 70%-90% stable - up to 5 yrs stimulation parameters may increase Hariz et al. (2008b); Limousin et al. (1999); Pahwa et al. (2006); Obwegeser et al. (2000); Zhang et al., (2009)

16 Parkinson s Disease

17 Parkinson s Disease Affects 1% to 3% of adults > 65 yrs

18 Parkinson s Disease Affects 1% to 3% of adults > 65 yrs Tremor, Bradykinesia, Rigidity Gait difficulties and postural instability

19 DBS for Who? Presence of symptoms of PD for 5 years No significant cognitive deficits or dementia

20 DBS for Who? Presence of symptoms of PD for 5 years No significant cognitive deficits or dementia Prognostic indicator: Motor Response to levodopa challenge (>33% improvement in UPDRS III from off-state)

21 Parkinson s Disease Despite best Medical Therapy

22 Parkinson s Disease Despite best Medical Therapy 40% pts continue to have motor fluctuations 28% experience levodopa-induced dyskinesias Schrag and Quinn (2000); Twelves et al. (2003); Schoenberg (1987)

23 Why Surgery?

24 Why Surgery? Troubling Dyskinesias

25 Why Surgery? Troubling Dyskinesias On / Off Motor Fluctuations

26 Why Surgery? Troubling Dyskinesias On / Off Motor Fluctuations Tremor Refractory to Medicine

27 Why Surgery? Troubling Dyskinesias On / Off Motor Fluctuations Tremor Refractory to Medicine Medication Side Effects intolerable

28 Surgery? Parkinson s Disease Despite best Medical Therapy

29 Surgery? Parkinson s Disease Despite best Medical Therapy Severe Dyskinesias ON meds

30 Surgery? Parkinson s Disease Despite best Medical Therapy Severe Dyskinesias ON meds Severe Motor Symptoms OFF meds

31 Window of Opportunity for

32 Why DBS?

33 Why DBS? Reversible, Not Permanent

34 Why DBS? Reversible, Not Permanent Adjustable

35 Why DBS? Reversible, Not Permanent Adjustable Relief of Motor Dysfunction

36 Why DBS? Reversible, Not Permanent Adjustable Relief of Motor Dysfunction 140,000 Cases Worldwide to Date

37 DBS Surgery: beginning 1987 Vim thalamus for PD (France)

38 Occurs as 2 Stages DBS procedure

39 DBS procedure: Stage I Local Anesthesia only Patient is Awake

40 DBS procedure: Stage I Local Anesthesia only Patient is Awake Overnight stay for monitoring

41 DBS procedure: Stage I Placement of the stereotactic frame

42 DBS procedure: Stage I Placement of the stereotactic frame

43 Surgical Technique: Targeting Sophisticated imaging and software enables precise targeting for optimal outcomes and minimal risk Microelectrode recording (MER) offers additional levels of verification of lead location

44 STN Target: MER in PD Gross et al. Movement Disorders (2006)

45 DBS for Parkinson s Disease STN (Subthalamic Nucleus) Bilateral implant FDA approval 2002 STN STN Insert 3D Image Here GPi (Globus Pallidus Interna) Bilateral implant FDA approval 2002 GPi GPi

46 DBS: STN target

47 DBS: Gpi Target

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49 DBS procedure: Stage I Implantation of DBS electrode spanning target Testing of DBS electrode for efficacy/side effects Contractions, paresthesias, gaze deviation Final placement and securement

50 DBS Procedure: Stage II Performed as a separate surgery General Anesthesia Short, Outpatient procedure Infraclavicular or subcostal placement Single or Dual-channel IPG New Rechargeable IPG available

51 DBS Procedure: Stage II Unilateral vs. Bilateral Implantation Staged IPG implantation

52 Outcomes Multi-center Studies evaluating DBS efficacy compared to pre-op baseline or best medical treatment

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56 Best Medical Therapy vs. DBS

57 Best Medical Therapy vs. DBS DBS found to be more effective in treating symptoms of PD

58 Best Medical Therapy vs. DBS GPi / STN DBS: PD pts received 5.2 hours of additional ON time without dyskinesias 104 more days ON per year!

59 Best Medical Therapy vs. DBS Dyskinesias were significantly reduced (>75%) compared to preoperative baseline and to those receiving best medical therapy sustained over 5 years

60 Early DBS for PD

61 Early DBS for PD 251 PD patients with early motor complications mean age, 52 years; mean duration of disease, 7.5 years randomized to DBS + meds OR medical therapy alone

62 Early DBS for PD The primary end point was quality of life, as assessed with the use of the Parkinson s Disease Questionnaire (PDQ-39) summary index

63 Early DBS for PD The primary end point was quality of life, as assessed with the use of the Parkinson s Disease Questionnaire (PDQ-39) summary index

64 Early DBS for PD Quality of Life

65 Early DBS for PD Quality of Life P = 0.002

66 Early DBS for PD: Quality of Life

67 Motor Symptoms Improvements Maintained Up to 5 Years In a 5-year study, DBS Therapy significantly improved OFF-medication assessments of tremor, rigidity, and akinesia/bradykinesia *Results for STN

68 Medication Reduction Change in Levodopa Use Over Time

69 DBS Procedure: Risks

70 DBS Procedure: Risks Risk of hemorrhage for bilateral lead placement

71 DBS Procedure: Risks Risk of hemorrhage for bilateral lead placement 1 4 % worldwide Limousin et al., 2008; Krack et al., 2003; Kumar et al., 2000; Wider et al., 2007; Lyons et al., 2002; Rezai et al; 2006

72 DBS Procedure: Risks Risk of hemorrhage for bilateral lead placement 1 4 % worldwide Most unlikely to be symptomatic Limousin et al., 2008; Krack et al., 2003; Kumar et al., 2000; Wider et al., 2007; Lyons et al., 2002; Rezai et al; 2006

73 Risk of Infection DBS Procedure: Risks

74 DBS Procedure: Risks Risk of Infection very low

75 DBS Procedure: Risks Risk of Infection very low Hardware problems (lead fracture / IPG failure) Rezai et al; 2006

76 DBS Procedure: Risks Risk of Infection very low Hardware problems (lead fracture / IPG failure) 4.3% per electrode Rezai et al; 2006

77 DBS Procedure: Risks These risks are lower compared to other cranial neurosurgical procedures

78 PATIENT ADVOCATES JULIE ANDERSON Parkinson s Disease DBS Patient since May 2015 FRANCES RABURN Essential Tremor DBS Patient since November 2015