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DBS-PD

Deep-Brain Stimulation of the Subthalamic Nucleus or the Pars Interna of the Globus Pallidus in Parkinson’s Disease

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Year of Publication: 2006

Authors: Frances M. Weaver, Kelly B. Follett, Charles L. Stern, ..., Jerrold L. Vitek

Journal: New England Journal of Medicine

Citation: N Engl J Med 2006;355:896–908. doi:10.1056/NEJMoa060281

Link: https://doi.org/10.1056/NEJMoa060281

Clinical Question

Does bilateral subthalamic nucleus deep brain stimulation improve quality of life and motor function compared to best medical therapy in patients with advanced Parkinson’s disease?

Bottom Line

Subthalamic DBS significantly improved quality of life and motor function in patients with advanced Parkinson’s disease, but carried a higher risk of serious adverse events compared to best medical therapy.

Major Points

  • Randomized controlled trial comparing subthalamic DBS to best medical therapy in 156 patients with advanced PD
  • Primary outcomes: PDQ-39 quality of life score and UPDRS-III motor score in the off-medication state at 6 months
  • DBS group had significantly greater improvements in both PDQ-39 (−9.5 vs −0.2, P=0.02) and UPDRS-III (−19.6 vs −0.4, P<0.001)
  • DBS patients reduced antiparkinsonian medication dose by 34%
  • Serious adverse events occurred more frequently with DBS (13% vs 4%), including surgical and stimulation-related complications
  • DBS improved motor fluctuations and reduced dyskinesias more than medication alone

Design

Study Type: Randomized, controlled, multicenter trial

Randomization: 1

Blinding: Unblinded intervention; assessments performed by blinded evaluators

Enrollment Period: 2002–2005

Follow-up Duration: 6 months

Centers: 7

Countries: USA

Sample Size: 156

Analysis: Intention-to-treat; paired t-tests and ANOVA for primary outcomes

Inclusion Criteria

  • Idiopathic Parkinson’s disease for ≥5 years
  • Age <75 years
  • Hoehn and Yahr stage ≥2
  • Severe motor symptoms or fluctuations not adequately controlled with medications
  • No significant cognitive impairment or psychiatric illness
  • Able to undergo surgery

Exclusion Criteria

  • Dementia
  • Major depression or psychosis
  • Other neurological disorders
  • Previous intracranial surgery
  • Contraindication to general anesthesia

Arms

FieldDeep Brain StimulationControl
InterventionBilateral subthalamic nucleus DBS using Medtronic system; stimulation parameters adjusted postoperatively; antiparkinsonian medications tapered as neededOptimization of antiparkinsonian medication regimen by movement disorder specialists using available pharmacologic agents
Duration6 months6 months

Outcomes

OutcomeTypeControlInterventionHR / OR / RRP-value
Change in PDQ-39 Summary Index and UPDRS-III motor score (off medication) at 6 monthsPrimaryPDQ-39: −0.2; UPDRS-III: −0.4PDQ-39: −9.5; UPDRS-III: −19.6PDQ-39: 0.02; UPDRS-III: <0.001
Change in medication doseSecondaryNo change−34% reduction<0.001
Time with dyskinesia (patient diary)Secondary3.1 h/day0.9 h/day<0.001
Serious adverse eventsAdverse4%13%
Intracerebral hemorrhageAdverse0%2.6%
InfectionAdverse0%2.6%

Subgroup Analysis

Greater improvements in motor function seen in patients with longer disease duration and more severe baseline UPDRS scores

Criticisms

  • Short follow-up duration (6 months) limits assessment of long-term benefit and risks
  • Non-blinded treatment introduces potential bias despite blinded assessments
  • Exclusion of older patients and those with cognitive issues may limit generalizability
  • Adverse events, though infrequent, were more common in DBS group

Funding

Department of Veterans Affairs Cooperative Studies Program and National Parkinson Foundation

Based on: DBS-PD (New England Journal of Medicine, 2006)

Authors: Frances M. Weaver, Kelly B. Follett, Charles L. Stern, ..., Jerrold L. Vitek

Citation: N Engl J Med 2006;355:896–908. doi:10.1056/NEJMoa060281

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