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Paul H. Gordon, MD; Qiping Yu, PhD; Clifford Qualls, PhD; Hal Winfield, RN; Sandra Dillon, RN; Paul E. Greene, MD; Stanley Fahn, MD; Robert E. Breeze, MD; Curt R. Freed, MD; Seth L. Pullman, MD, FRCPC

Arch Neurol. 2004;61:858-861.

Background  Embryonic nigral cell implants are a novel treatment for Parkinson disease (PD). Reaction time (RT) and movement time (MT) analysis, validated quantitative measures of premovement neural processing and motor execution, can be used as objective physiological markers of motor performance in PD.

Objectives  To gauge the change in motor performance in patients with PD who received implants, and to determine whether the physiological findings correlate with clinical outcome measures after transplantation.

Design  Double-blind, placebo-controlled trial.

Patients  Forty patients with levodopa-responsive, Hoehn and Yahr stage III or greater PD.

Interventions  Random assignment to embryonic tissue implants or placebo (sham) operation.

Main Outcome Measures  Combined RT + MT scores measured preoperatively and at 4 and 12 months postoperatively in the "off" state.

Results  The difference in mean RT + MT scores between the sham and implant groups was statistically significant (P = .005) and was greatest in those 60 years or older (P = .003). Changes correlated with Unified Parkinson's Disease Rating Scale off scores at 4 (r = 0.87, P = .001) and 12 (r = 0.75, P = .01) months in those younger than 60 years. There was a significant deterioration in the sham surgery group at 12 months (P = .03) that was thought to be due to worsening in subjects 60 years and older (P<.001).

Conclusions  The physiological measures detected significant changes in patients undergoing embryonic nigral cell implants and correlated directly with clinical outcome measures. Comprehensive analyses of RT paradigms can document subtle changes in motor performance over time, making them useful outcome measures in therapeutic trials of PD. These findings support further research into nigral cell implantation for PD.

From the Department of Neurology and Clinical Motor Physiology Laboratory, Columbia-Presbyterian Medical Center, New York, NY (Drs Gordon, Yu, Greene, Fahn and Pullman; Mr Winfield; and Ms Dillon); Department of Biostatistics, University of New Mexico, Albuquerque (Dr Qualls); and Departments of Neurosurgery (Dr Breeze), Medicine (Dr Freed), and Pharmacology (Dr Freed), University of Colorado, Denver (Drs Breeze and Freed).

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