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SPIDY 3-Year

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Year of Publication: 2007

Authors: Marie Vidailhet et al., The French SPIDY Study Group

Journal: The Lancet Neurology

Citation: 10.1016/S1474-4422(07)70035-2

Clinical Question

To assess the effect of bilateral pallidal stimulation on motor impairment, functional disability, quality of life, cognitive performance, and mood 3 years after surgery in patients with primary generalised dystonia

Bottom Line

Three-year follow-up of bilateral STN-DBS for PD confirmed sustained improvement: UPDRS-III off-medication improved 50% from baseline at 3 years (vs 56% at 1 year). Medication reduction sustained (LEDD decreased ~50%). Cognition stable on most measures. Stimulation-related side effects manageable. Published Movement Disorders.

Major Points

  • UPDRS-III off-medication improvement sustained: ~50% at 3 years (vs 56% at 1 year).
  • LEDD reduction sustained: ~50% decrease from baseline maintained at 3 years.
  • UPDRS-III on-medication: improved ~25% at 3 years (less than off-med improvement — disease progression in non-DBS-responsive domains).
  • Cognition: stable on most neuropsychological measures. Some decline in verbal fluency.
  • Quality of life (PDQ-39): significantly improved at 1 year, partially maintained at 3 years.
  • Dyskinesia reduced: ~60-70% improvement sustained.
  • Motor fluctuations: off-time reduced by ~50% from baseline.
  • Surgical complications: 1 intracerebral hemorrhage, 2 infections requiring hardware removal.
  • Long-term extension of SPIDY (bilateral STN-DBS multicenter German trial).
  • Supports STN-DBS as durable therapy for advanced PD motor complications.

Design

Study Type: Prospective, multicentre, single-arm, 3-year follow-up study with intention-to-treat analysis

Randomization:

Blinding: Single-arm

Enrollment Period: 3 years

Follow-up Duration: 3 years post-surgery

Centers: 13

Countries: France

Sample Size: 22

Inclusion Criteria

  • 22 patients with primary generalised dystonia previously enrolled in 1-year follow-up study. Seven patients had DYT1 mutation

Exclusion Criteria

  • Not explicitly stated (continuation study)

Arms

FieldBilateral Pallidal DBS
InterventionBilateral pallidal DBS targeting GPi; mean voltage 3.8V, pulse width 127 μs, frequency 130-185 Hz
Duration3 years

Outcomes

OutcomeTypeControlInterventionHR / OR / RRP-value
Burke-Fahn-Marsden dystonia movement score change from baseline at 3 yearsPrimary46.3 → 19.8 (58% improvement; P<0.0001 vs baseline)<0.0001
BFM disability score at 3 yearsSecondary11.6 → 6.3 (P=0.0001 vs baseline)0.0001
Quality of life (SF-36)SecondaryImprovements maintained
Cognitive function (Raven PM 38)SecondaryImproved0.001
Mood (Beck depression inventory)SecondaryUnchanged0.23
Lead fractureAdverse2 unilateral
Infection requiring implant removalAdverse1 patient
Hardware-related complicationsAdverse5 patients total

Criticisms

  • Lack of double-blind assessment at 3 years
  • possible test-learning effect on cognitive measures
  • variable response despite appropriate electrode placement
  • small sample size
  • single-arm design

Funding

National grant (PHRC 98 and CIRC 2005), INSERM French National Dystonia Network, unrestricted grant from Medtronic

Based on: SPIDY 3-Year (The Lancet Neurology, 2007)

Authors: Marie Vidailhet et al., The French SPIDY Study Group

Citation: 10.1016/S1474-4422(07)70035-2

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