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. 2025 Nov 18.
doi: 10.1007/s00702-025-03066-z. Online ahead of print.

Impact of device-aided therapies on quality of life in patients with Parkinson's disease. A comparative multicenter observational study

Collaborators, Affiliations

Impact of device-aided therapies on quality of life in patients with Parkinson's disease. A comparative multicenter observational study

Diego Santos-García et al. J Neural Transm (Vienna). .

Abstract

Device aided-therapies (DATs) improve health-related quality of life (HRQoL) in people with Parkinson's disease (PwP). However, no studies comparing all DATs have been conducted to date. Our aim was to compare the effect of different DATs on HRQoL and other disease-related variables in PwP. Data from baseline (V1) and the 6-month follow-up visit (V3.6 M) were collected from a descriptive, observational, prospective, multicenter, clinical registry conducted in Spain entitled DATs-PD GETM Spanish Registry. The primary endpoint was the change from V1 to V3.6 M in the 39-item Parkinson's Disease Questionnaire (PDQ-39) total score. Relative change (RC) and Cohen's d (d) effect were applied. The effect over many other variables was also analyzed. HRQoL improved significantly in the entire cohort (N = 137) with a moderate decrease of 13.4% in the PDQ-39 total score (from 58.9 ± 22.9 at V1 to 51.0 ± 26.8 at V3.6 M; d = 0.51; p < 0.0001). No differences in the change of the PDQ-39 total score were detected between both subcutaneous therapies (i.e., foslevodopa/foscarbidopa [fLD/fCD] and continuous subcutaneous apomorphine infusion [CSAI]; p = 0.666) and between subcutaneous and enteral therapies (p = 0.721). Although a greater improvement in HRQoL was observed in PwP treated with deep brain stimulation (DBS) (N = 30; RC = -26.3%; d = 0.83; p = 0.002) compared to those who received a pump system (N = 107; RC = -10.2%; d = 0.41; p = 0.003) (p = 0.009), the effect was not significant after adjustment for age, sex, and disease duration (p = 0.161). Off time, dyskinesia, motor symptoms, and non-motor symptoms improved significantly in the entire cohort. HRQoL improved in PwP after being treated with a DAT.

Keywords: Deep Brain stimulation; Device-aided therapies; Infusion; Parkinson’s disease; Quality of life; Subcutaneous.

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Conflict of interest statement

Declarations. Conflict of interest: The authors declare no competing interests. Ethical compliance statement: The project is being conducted in accordance with the ICH Good Clinical Practice version 6 Revision 2 standard, the fundamental ethical principles established in the Declaration of Helsinki and the Oviedo Convention, as well as the Spanish legal requirements for biomedical research (Biomedical Research Law 14/2007). The Project has been approved on 02/APR/2024 by the IRB “Comité de Ética de la Investigación Clínica de Galicia from Spain” with code number 2024/109. Written informed consents from all participants in this study were obtained. We confirm that we have read the Journal’s position on issues involved in ethical publication and affirm that this work is consistent with those guidelines. The protocol, statistical analysis plan and unidentified participant data will be available on request.

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