Nejvíce citovaný článek - PubMed ID 36599767
Brain Response Induced by Peroneal Electrical Transcutaneous Neuromodulation Invented for Overactive Bladder Treatment, as Detected by Functional Magnetic Resonance Imaging
INTRODUCTION: Currently, there is no causal cure for Parkinson's disease (PD), and medications and other therapeutic procedures only allow for the reduction of symptoms. Noninvasive neuromodulation is among the potentially promising treatments for PD patients. The present pilot study aimed to evaluate the safety and efficacy of peroneal electrical Transcutaneous NeuroModulation (peroneal eTNM®) in the treatment of PD symptoms with a particular emphasis on disease-related quality of life. METHODS: Twelve patients with clinically established Parkinsońs disease (8 males; mean age 59.5 ± 11.6 years) were enrolled. In addition to state-of-the-art background pharmacotherapy for PD, patients were treated with peroneal eTNM® daily for 30 min for 6 weeks followed by 6 weeks of follow-up without stimulation. The primary endpoint was safety and tolerability, the secondary endpoint was the response of the condition on the 'add-on' peroneal eTNM®. RESULTS: Peroneal eTNM® proved to be feasible for home treatment in the PD population. Treatment-related adverse events were not reported throughout the study. Along with an excellent safety profile, peroneal eTNM® showed considerable positive trends in terms of improvement in quality of life as measured by EQ-5D-5L questionnaire. There was a definitive trend toward a reduction in Section III of the Unified Parkinson's Disease Rating Scale showing positive changes in tremor-related items. At the end of the study, 50 % of the patients were considered clinical responders. CONCLUSIONS: Larger and more rigorously designed studies are needed to validate the utility and position of peroneal eTNM® in the treatment of patients with PD.
- Klíčová slova
- Neuromodulation, Parkinson’s disease, Peroneal nerve, Quality of life, Tremor, URIS I™ neuromodulation system,
- Publikační typ
- časopisecké články MeSH
PURPOSE: The aim of this prospective 12-month follow-up study is to evaluate the persistence of the treatment effect achieved during the initial course of peroneal electrical Transcutaneous NeuroModulation (peroneal eTNM®) in patients with overactive bladder (OAB). METHODS: This study enrolled 21 female patients who participated in two previous clinical studies designed to assess the efficacy and safety of peroneal eTNM®. The patients were left without subsequent OAB treatment and were invited to attend regular follow-up visits every 3 months. The patient's request for additional treatment was considered an indicator of the withdrawal of the treatment effect of the initial course of peroneal eTNM®. The primary objective was the proportion of patients with persisting treatment effect at follow-up visit 12 months after initial course of peroneal eTNM®. Descriptive statistics are presented using median, correlation analyses were computed using a nonparametric Spearman correlation. RESULTS: The proportion of patients with persistent therapeutic effect of the initial course of peroneal eTNM® was 76%, 76%, 62% and 48% at 3, 6, 9 and 12 months, respectively. There was a significant correlation between patient reported outcomes and the number of severe urgency episodes with or without urgency incontinence as reported by patients at each follow-up visit (p = 0.0017). CONCLUSION: The treatment effect achieved during the initial phase of peroneal eTNM® persists for at least 12 months in 48% of patients. It is likely that the duration of effects is dependent on the length of the initial therapy.
- Klíčová slova
- Effect persistence, Overactive bladder, Peroneal electrical Transcutaneous NeuroModulation, Peroneal nerve, URIS® device, Urgency,
- MeSH
- elektrostimulační terapie * MeSH
- hyperaktivní močový měchýř * terapie MeSH
- lidé MeSH
- následné studie MeSH
- prospektivní studie MeSH
- transkutánní elektrická neurostimulace * MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH