According to a report published in BMJ, a new clinical study was being developed to investigate the benefits of an automated symptom monitoring device, also known as a Parkinson’s Holter, and its ability to improve motor symptoms in patients with Parkinson’s disease (PD).
Motor complications or fluctuations are common in patients with PD and are not easily controlled. While doctors typically rely on patients’ self-reported data and diaries, an objective system of measuring motor fluctuations can be very useful in optimizing medication and improving disease control.
The Parkinson Holter, an ambulatory automatic symptom monitoring device from Sense4Care SL, is an easy-to-carry medical device that provides vital data to improve the treatment regimen. The system records motor fluctuations, dyskinesias, bradykinesias and the freezing of gait episodes during daily activities.
The current study will examine the clinical outcomes of patients with Parkinson’s disease using various sources of information on motor fluctuations.
162 patients with Parkinson’s disease and difficult-to-control motor fluctuations as well as neurologists from at least 40 hospitals in Spain are to take part in the cluster-randomized controlled clinical study. Neurologists are randomly assigned to one of 3 arms based on the source of information used to decide about therapeutic adjustments: 7-day data based on Parkinson’s Holter, a 7-day diary of motor fluctuations, or self-reported data only during the visit (the therapeutic adjustment is based only on the clinical information gathered during the consultation).
The primary aim of the study is to determine the effectiveness of clinical control in patients with Parkinson’s disease based on the daily off-time through a diary of motor fluctuations. Secondary endpoints are doctor visits and telephone contacts, therapeutic changes, exercise programs, adherence, motor complications, daily punctuality, freezing of gait episodes, quality of life, autonomy in activities of daily living, and side effects.
For their exploratory goal, researchers will examine the Holter’s non-inferiority for PD symptoms over the Motor Fluctuation Diary.
One of the major limitations of this study is the potential observer bias due to the lack of blinding of the neurologists and the potential impact on several secondary endpoints measured by the neurologists.
The results of this clinical study, which is the first to examine the effectiveness of a Parkinson’s holter in improving motor symptoms in patients with Parkinson’s, are expected in 2022.
“The results of this study will demonstrate the practical benefits of objective information from a [Parkinson] Holter and with it the convenience of adopting this technology in clinical practice and in future clinical studies, ”the study researchers write.
Disclosure: This research was assisted by AbbVie SLU. For a full list of disclosures, see the original reference
Rodríguez-Molinero A, Hernández-Vara J, Miñarro A, et al. Multicenter, randomized, single-blind, parallel-group study comparing the effectiveness of a Holter for Parkinson’s symptoms with other clinical monitoring methods: study protocol. BMJ open. 2021; 11 (7): e045272. doi: 10.1136 / bmjopen-2020-045272