CLINICAL OUTCOMES: MOVEMENT DISORDERS DEEP BRAIN STIMULATION

CLINICAL SUMMARY: DBS THERAPY FOR PARKINSON'S DISEASE AND ESSENTIAL TREMOR

The clinical use of implantable deep brain stimulation systems for Parkinson’s disease and essential tremor is supported by clinical studies on DBS therapy for Parkinson's disease, and clinical studies on DBS therapy for tremor.

Medtronic DBS Therapy for Parkinson's Disease and Essential Tremor Clinical Summary includes data from:

  • Medtronic Parkinson's Disease Global Study
  • Comparison of Best Medical Therapy and Deep Brain Stimulation of Subthalamic Nucleus and Globus Pallidus for the Treatment of Parkinson's Disease: Phase I
  • Comparison of Deep Brain Stimulation of the Subthalamic Nucleus and Deep Brain Stimulation of the Globus Pallidus internal: Phase II
  • Comparison of Best Medical Therapy and Deep Brain Stimulation of the Subthalamic Nucleus for the Treatment of Parkinson's Disease with Early Motor Complications
  • U.S. and European Tremor Trials

The summary applies to Activa™ RC, Activa PC, Activa SC, Kinetra™, and Soletra™.

Access the clinical summary on the Medtronic Manual Library by entering M197935 in the Manual Document Number search field.

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CLINICAL SUMMARY: DBS THERAPY FOR DYSTONIA

The effectiveness of Medtronic DBS Therapy System in treating dystonia has not been demonstrated in controlled clinical trials.

Medtronic DBS Therapy for Dystonia Clinical Summary contains information on documented clinical studies and case reports on dystonia patients that were not sponsored by Medtronic.

The summary applies to Activa PC, Activa SC, and Soletra.

Access the clinical summary on the Medtronic Manual Library by entering M944810 in the Manual Document Number search field.

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PARKINSON’S DISEASE: MOTOR FUNCTION

DBS (STN) patients at 24-month follow-up achieved a 20% statistically significant improvement (2.1 hours from baseline) compared to 2% (0.2 hours) with BMT alone in the study of those with recent onset of motor complications. "On" time without troublesome dyskinesia at baseline was 10.3 hours.1,2

DBS patients gained up to 5.2 hours each day compared to 0 hours with BMT in the study of those with longer-standing motor complications at 6 months follow-up. DBS Therapy had a sustained improvement to 24 months with a 5.0 hour gain for STN and a 5.2 hour gain for GPi. "On" time without troublesome dyskinesias at baseline was only 6.4 hours.2

DBS Therapy can reduce "off" time.2

  • DBS (STN) showed a 39% statistically significant improvement (-1.9 hours from baseline) compared to 2% (-0.1 hours) with BMT alone at 24-months follow-up in the study of those with recent onset of motor complications.1,2
  • "Off" time for DBS patients was reduced by 2.9 hours each day compared to a reduction of 0.1 hours with BMT at 6-months follow-up in the study of patients with longer-standing motor complications. DBS had a sustained improvement with a reduction of 3.1 hours for STN and 2.8 hours for GPi to 24 months.2

In an off-medication condition, DBS therapy showed improvement (of at least 5 points in the UPDRS III).2

  • Those with DBS (STN) improved 85% from baseline to 24 months compared to 36% in patients with BMT alone in the study of patients with recent onset of motor complications.1,2
  • DBS improved 89% from baseline to 6 months compared to 37% in the patients with BMT alone in the study of patients with longer-standing motor complications. 83% of STN patients and 74% of GPi patients improved from baseline to 24 months.2

Parkinson's Disease: Quality of Life

Medtronic DBS along with Parkinson’s medication improves quality of life (based on PDQ-39) at 24-months follow-up.2

  • DBS (STN) showed a statistically significantly improvement of 26% versus a 1% decline in subjects receiving BMT alone in the study of those with recent onset of motor complications.1,2
  • STN patients improved by 12.6% and GPi patients improved by 12.5% versus baseline in the study of patients with longer-standing motor complications.2

Patients experienced improvement in various activities of daily living (based on the UPDRS II) at 24-months follow-up.2

  • DBS (STN) patients experienced a statistically significant 30% improvement in activities of daily living versus baseline in the study of those with recent onset of motor complications.1,2
  • STN patients improved activities of daily living by 16.9% and GPi patients by 18.8% versus baseline in the study of those with longer-standing motor complications.2
1

Schuepbach WMM, Rau J, Knudsen K, et al. Neurostimulation for Parkinson’s disease with early motor complications.N Engl J Med. February 14, 2013; 368:610-622.

2

Medtronic DBS Therapy for Parkinson’s Disease and Essential Tremor Clinical Summary, 2015.