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- Title
Deep Brain Stimulation in the Caudal Zona Incerta versus Best Medical Treatment in Patients with Parkinson's Disease; A Randomised Blinded Evaluation.
- Authors
Blomstedt, Patric; Linder, Jan; Stenmark, Rasmus; Hariz, Gun-Marie; Forsgren, Lars; Hariz, Marwan
- Abstract
Objectives: The aim of the present work was to evaluate in a single blinded randomized manner the effect of bilateral DBS in the caudal zona Incerta (cZi) versus best medical treatment, in a group of patients with PD who would fullfil the criteria for bilateral STN DBS. Methods: Patients that would normally have been considered for bilateral STN DBS were eligible for participation in this study. Patients were randomized to either bilateral cZi DBS within 1 month or to best medical treatment. The primary endpoints were the differences between baseline and 6 months scores between the two groups for UPDRS III off-medication and PDQ-39. All UPDRS-III evaluations were videotaped with the patients wearing head caps and rated by two assessors unaware of the patients' previous allocation. Results: Of 20 included patients (10 in each group) one patient randomized to surgery did not accept turning off the DBS and was therefore excluded. Hence, 19 patients were evaluated at 6 months. There were no differences between the groups concerning patients' demographic and clinical characteristics at baseline. Mean UPDRS III scores off-medication on stimulation improved from 33.2 at baseline to 19.4 at 6 months (41.6%, p = 0.001). The highest degree of improvement concerned the scores of tremor items of the UPDRS (5.1 off-med at baseline vs. 0.4 on stimulation off medication, p < 0.002). There were no changes of scores in the medical group. The on-medication UPDRS III scores did not change in any of the groups. For PDQ-39, the total index was improved in the surgical group by 8.3 points from 22.8 to 14.5 (36.4%, p = 0.038) and in the medical group by 6.1 points from 25.0 to 18.9 (24.4%, p = 0.028). While the improvement in PDQ39 was significant within each group, the difference between the groups at 6 months was not significant. Neither dyskinesia scores nor Levodopa equivalent daily doses did change in any of the groups. Mean stimulation parameters at 6 months were 2.48 ± 0.43 V, 152.2 ± 10.3 Hz and 63.3 ± 9.7 uS. In the surgical group one patient suffered a deep venous thrombosis in one leg three months after surgery. No complications were encountered in the medical group. Conclusions: DBS in the cZi was in this blinded randomized study demonstrated to be safe and superior to medical therapy alone. The degree of improvement achieved with cZi DBS was somewhat modest compared to the results reported in non-randomized studies of both cZi and STN DBS. The results were, however, broadly similar to the results reported in randomized studies of bilateral STN DBS, with a marked robust effect of cZI DBS on tremor. Further studies are necessary in order to determine the role of cZi DBS and its symptomatic impact profile, in the surgical armamentarium for PD, especially in relation to STN DBS.
- Publication
Stereotactic & Functional Neurosurgery, 2016, Vol 94, p25
- ISSN
1011-6125
- Publication type
Article
- DOI
10.1159/000448961