bilateral globus pallidus internus (GPi) DBS. Standard rating scales were used to quantify their neurological improvement. The results were ana- lyzed by applying the Wilcoxon signed-rank test to compare rating scales within each group (preoperatively and at the most recent follow-up visit). In addition, a univariate analysis was performed for each subgroup to evaluate the rate of change in patient rating scales over time. RESULTS: Both groups experienced a statistically significant improve- ment in their rating scores at both 1 and 2 years after surgery. Mean follow-up was 29.9 months (range, 24–48 months). At 2-year follow-up, the spasmodic torticollis group exhibited a 59% improvement in their total Toronto Western Spasmodic Torticollis Rating Scale rating score, and the generalized dystonia group attained a 46% improvement in their overall Burke-Fahn-Marsden Dystonia Rating Scale evaluation. The total neurological rating scores for each group of patients improved gradually before reaching a plateau. Ninety-five percent of the final improvement was attained by 6.4 months in the generalized dystonia group and by 6.6 months in those with spasmodic torticollis. There was no significant improvement at 1 year after surgery. Postoperative complications oc- curred in three patients and comprised electrode displacement, lead fracture, and status dystonicus. CONCLUSION: These findings add further support to GPi DBS as an effective treatment for generalized dystonia and spasmodic torti- collis and furnish important information as to the expected rate and magnitude of improvement and the point at which no further gains can be reasonably anticipated. 781 Bilateral Intraputaminal Infusion of Liatermin (Glial Cell Line-derived Neurotrophic Factor r-metHuGDNF) in Subjects with Advanced Parkinson’s Disease Steven Gill, F.R.C.S., Peter Heywood, F.R.C.P., Andres M. Lozano, M.D., Ph.D., Anthony Lang, Elena Moro, M.D., Richard Penn, Arif Dalvi, M.D., Kim J. Burchiel, M.D., John Nutt, M.D., Patrick Kelly, M.D., Michael Hutchinson, M.D., W.J. Elias, M.D., Frederic Wooten, M.D., Dennis Turner, M.D., Burton Scott, M.D., Nikunj Patel, F.R.C.S., Edward R. Laws, Jr., M.D., James Matcham, Ph.D., Robert Coffey, M.D., Michael Traub, M.D. INTRODUCTION: Liatermin consistently has demonstrated neuro- protective and neuroregenerative properties in rodent and nonhuman primate models of Parkinson’s disease (PD). A previous trial of intrace- rebroventricular infusions of glial cell line-derived neurotrophic factor (GDNF) did not yield the expected improvements noted in the animal models. However, direct targeted delivery of GDNF has resulted in marked clinical improvement in open-label pilot trials of continuous intraputaminal (IPu) infusion of liatermin in patients with advanced PD. METHODS: This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study that evaluated safety and efficacy in 34 subjects with advanced idiopathic PD. The SynchroMed Infusion System (Medtronic, Inc., Minneapolis, MN) was used to administer liatermin (15 mg/putamen/d) or placebo bilaterally into the dorsal posterior putamen via stereotactically implanted bilateral IPu catheters. A blinded neuroradiologist independently evaluated catheter tip placement and the delivery of study material on magnetic resonance images. Other blinded individuals evaluated before- and after-treatment 18 F-dopa positron emission tomographic (PET) scans. Subjects continued to receive oral anti-parkinsonian medications. The primary outcome was the percent change from baseline to 6 months in the Unified Parkinson’s Disease Rating Scale (UPDRS) motor score in the practically defined off condition. RESULTS: Thirty-four subjects received implants and were ran- domized into the trial. The most serious implant-related adverse events included one symptomatic intraparenchymal hemorrhage, one subdural hygroma, and one recurrent infection that required device removal and reimplantation. No deaths or permanent neurological worsening occurred. Because the blinded phase continues through May 2004, complete unblinded safety and efficacy results will be revealed during the presentation of the data at the meeting. Efficacy results include the percent change in the UPDRS motor score in the practically defined off period and the findings of the pretreatment and posttreatment 18 F-dopa PET studies. CONCLUSION: Continuous infusion of liatermin into the dorsal posterior putamen is well tolerated and may result in improvement (to be clarified once results are available) of parkinsonian motor symptoms in patients with advanced PD. 782 Targeted Subthreshold Cortical Stimulation for Recovery of Motor Hand Function after Hemiparetic Stroke Robert M. Levy, M.D., Ph.D., Martin Weinand, M.D., Sean Ruland, M.D., David Lowry, M.D., Rima Dafer, M.D. INTRODUCTION: A prospective, randomized, multicenter feasi- bility study tested the hypotheses that targeted subthreshold cortical stimulation is safe and effective for motor hand function recovery after hemiparetic stroke. METHODS: Twenty-four patients with cortical and/or subcortical stroke with hemiparesis are undergoing functional magnetic resonance imaging and either 6 weeks of 1) rehabilitation plus epidural motor hand area cortical stimulation (pulse frequency  100 Hz, pulse duration  250 microsec, treatment current  5.0  1.2 mA) during rehabilitation (n  12) or 2) the same rehabilitation protocol alone (n  12) with a 12-week follow-up period. The following outcome measures are obtained during baseline, treatment, and follow-up: Arm Motor Fugl-Meyer (AMFM), Strength subscore of the Stroke Impact Scale (SIS), Emotion subscore of the SIS, SIS Physical Domain, Hand Grip Strength, and NIH Stroke Scale. Statistical analysis is performed on all data with analysis of variance, with significance defined by P  0.05. RESULTS: A total of 16 men and 8 women, ages 26 to 80 years (mean  standard deviation, 56  12 yr) enrolled in and completed the study. There was no mortality or neurological deterioration; one patient had an acute postoperative seizure unrelated to the device or treatment. At the time of abstract submission, 17 patients (7 in the investigational treatment group, 10 in the control group) had completed the treatment protocol. Patients receiving cortical stimulation plus rehabilitation im- prove in hand/arm function to a greater degree than patients receiving rehabilitation alone. The AMFM scores, by intention-to-treat analysis, demonstrated a 7.8-point improvement for treatment patients versus 3.7-point improvement for control patients (maximum of 66 points). A 3-point improvement is considered clinically meaningful. Statistical anal- ysis will be performed upon study conclusion. CONCLUSION: These preliminary results suggest safety and effi- cacy of subthreshold epidural cortical stimulation for recovery of motor arm/hand function during rehabilitation after hemiparetic stroke. Further research is needed to validate the therapeutic effect. ABSTRACTS OF OPEN PAPERS 480 | VOLUME 55 | NUMBER 2 | AUGUST 2004 www.neurosurgery-online.com Downloaded from https://academic.oup.com/neurosurgery/article-abstract/55/2/480/2744455 by University of California-SB user on 23 March 2018