Nicholas J Brandmeir1,2, Cheryl L Brandmeir2,3, David Carr4, Kristine Kuzma4, James McInerney4. 1. Blanchette Rockefeller Neuroscience Institute. 2. West Virginia University Department of Neurosurgery, Morgantown, WV. 3. West Virginia University Department of Human Performance, Morgantown, WV. 4. Department of Neurosurgery, Penn State Milton S. Hershey Medical Center, Hershey, PA.
Abstract
BACKGROUND: Falls and postural instability (PI) are major sources of morbidity in Parkinson disease (PD). Deep brain stimulation (DBS) is a major therapy for PD. The effects of DBS on PI and falls remain controversial. OBJECTIVE: To study if DBS worsens PI, validated measures of PI (Timed Up and Go, Berg Balance Scale, Unified Parkinson's Disease Rating Scale 3.12 [Pull Test], and the Biodex Sway Index with eyes closed on a firm and soft surface) and reported falls were used to prospectively evaluate the effect of DBS on PI at 3 and 12 mo postoperatively compared to baseline measurements. The primary outcomes were a positive result on 4 out of the 5 PI tests and falls. METHODS: Patients presenting for DBS were prospectively enrolled and evaluated at presentation and, 3 and 12 mo postoperatively. All tests were performed at each visit. RESULTS: At 3 mo 4 of 5 positive showed noninferiority to baseline, with a rate of 28% vs 41% (relative risk [RR] 0.8 [0.5-1.3]). At 12 mo, 4 of 5 positive had a rate of 35% vs 30% (RR 1.2 [0.8-1.8]) and falls had a rate of 54% vs 46% (RR 1.2 [0.6-2.3]). These did not meet criteria to prove noninferiority. Sensitivity analysis at 12 mo showed noninferiority for 4 of 5 (RR 0.9 [0.6-1.5]) but not falls (RR 1.1 [0.5-2.3]). CONCLUSION: This evidence is consistent with the hypothesis that DBS does not worsen PI when measured at 3 and 12 mo postoperatively.
BACKGROUND: Falls and postural instability (PI) are major sources of morbidity in Parkinson disease (PD). Deep brain stimulation (DBS) is a major therapy for PD. The effects of DBS on PI and falls remain controversial. OBJECTIVE: To study if DBS worsens PI, validated measures of PI (Timed Up and Go, Berg Balance Scale, Unified Parkinson's Disease Rating Scale 3.12 [Pull Test], and the Biodex Sway Index with eyes closed on a firm and soft surface) and reported falls were used to prospectively evaluate the effect of DBS on PI at 3 and 12 mo postoperatively compared to baseline measurements. The primary outcomes were a positive result on 4 out of the 5 PI tests and falls. METHODS:Patients presenting for DBS were prospectively enrolled and evaluated at presentation and, 3 and 12 mo postoperatively. All tests were performed at each visit. RESULTS: At 3 mo 4 of 5 positive showed noninferiority to baseline, with a rate of 28% vs 41% (relative risk [RR] 0.8 [0.5-1.3]). At 12 mo, 4 of 5 positive had a rate of 35% vs 30% (RR 1.2 [0.8-1.8]) and falls had a rate of 54% vs 46% (RR 1.2 [0.6-2.3]). These did not meet criteria to prove noninferiority. Sensitivity analysis at 12 mo showed noninferiority for 4 of 5 (RR 0.9 [0.6-1.5]) but not falls (RR 1.1 [0.5-2.3]). CONCLUSION: This evidence is consistent with the hypothesis that DBS does not worsen PI when measured at 3 and 12 mo postoperatively.
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