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DBS-PD

A Randomized Trial of Deep-Brain Stimulation for Parkinson's Disease

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Year of Publication: 2006

Authors: Deuschl G, Schade-Brittinger C, Krack P, ..., Voges J

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

PDF: https://www.nejm.org/doi/pdf/10.1056/NEJ...ticleTools=true

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?

Study Overview

Objective

To determine whether subthalamic deep brain stimulation (DBS) improves quality of life and motor function more than best medical therapy in advanced Parkinson's disease.

Study Summary

DBS markedly improved PDQ-39 quality of life score and UPDRS-III score
Serious adverse events were more frequent with DBS vs medication group

Intervention

156 patients randomized in matched pairs to receive bilateral subthalamic DBS or best medical management; primary endpoints were 6-month changes in PDQ-39 and UPDRS-III scores off medication.

Patients per Arm

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-pairs, multicenter trial comparing subthalamic DBS plus medication to best medical therapy alone 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 (mean improvement 9.5, 50/78 pairs favored DBS, P=0.02) and UPDRS-III (mean improvement 19.6, 55/78 pairs favored DBS, P<0.001)
Neurostimulation improved PDQ-39 subscales for mobility, ADL, emotional well-being, stigma, and bodily discomfort by 24–38%
Serious adverse events occurred more frequently with DBS (13% vs 4%, P<0.04) and included a fatal intracerebral hemorrhage
Overall frequency of adverse events was higher in the medication group (64% vs 50%, P=0.08)

      

Design

Study Type: Randomized-pairs, controlled, multicenter trial

Randomization: 1

Blinding: Unblinded intervention; assessments performed by blinded evaluators

Enrollment Period: 2002–2005

Follow-up Duration: 6 months

Countries: Germany

Sample Size: 156

Analysis: Pairwise comparisons of matched pairs; primary end points analyzed as changes from baseline to 6 months

Inclusion Criteria

Idiopathic Parkinson's disease for ≥5 years
Age <75 years
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

Baseline Characteristics

Characteristic	Control	Active
Age	62.4 ± 8.4	61.7 ± 9.0
Sex - Male	76%	72%
Disease duration	11.2 ± 5.1 years	11.7 ± 4.6 years
UPDRS-III (off meds)	44.3 ± 13.0	45.3 ± 12.8
PDQ-39 score	49.1 ± 14.9	50.5 ± 15.2

Arms

Field	Deep Brain Stimulation	Control
Intervention	Bilateral subthalamic nucleus DBS plus antiparkinsonian medication; stimulation parameters adjusted postoperatively; medications tapered as needed	Optimization of antiparkinsonian medication regimen by movement disorder specialists using available pharmacologic agents
Duration	6 months	6 months

Outcomes

Outcome	Type	Control	Intervention	P-value
Change in PDQ-39 Summary Index and UPDRS-III motor score (off medication) from baseline to 6 months	Primary	PDQ-39: −0.2; UPDRS-III: −0.4	PDQ-39: −9.5 (mean improvement 9.5); UPDRS-III: −19.6 (mean improvement 19.6)	PDQ-39: 0.02 (50/78 pairs favored DBS); UPDRS-III: <0.001 (55/78 pairs favored DBS)
Change in medication dose	Secondary	No change	−34% reduction	<0.001
Time with dyskinesia (patient diary)	Secondary	3.1 h/day	0.9 h/day	<0.001
PDQ-39 subscales (mobility, ADL, emotional well-being, stigma, bodily discomfort)	Secondary		24–38% improvement
Serious adverse events	Adverse	4%	13%	<0.04
Overall adverse events	Adverse	64%	50%	0.08
Intracerebral hemorrhage	Adverse	0%	2.6% (including one fatal)
Infection	Adverse	0%	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 (≥75 years) and those with cognitive issues may limit generalizability
Serious adverse events, though infrequent, were more common in DBS group and included a fatal intracerebral hemorrhage

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