A new clinical trial has been designed to explore the benefits of an automated symptom monitoring device, also referred to as the Parkinson Holter, and its ability to improve the motor symptoms of patients with Parkinson disease (PD), according to a report published in BMJ Open.
Motor complications or fluctuations are highly prevalent among patients with PD and are not easily controlled. While physicians usually rely on self-reported data and diaries kept by the patients, an objective system for measuring motor fluctuations may be very useful to help optimize medication regimens and improve disease control.
The Parkinson Holter, an ambulatory automated symptom monitoring device manufactured by Sense4Care SL, is an easy to carry medical device that provides important data to improve the treatment regimen. The system records motor fluctuations, dyskinesias, bradykinesia and freezing of gait episodes during daily activities.
The current study will investigate the clinical outcomes of patients with PD according to various sources of information on motor fluctuations.
The cluster-randomized controlled clinical trial is expected to include 162 patients with PD and difficult to control motor fluctuations, as well as neurologists from at least 40 hospitals in Spain. Neurologists will be randomly assigned to 1 of 3 arms, according to the source of information used to decide on therapeutic adjustments: 7-day data based on the Parkinson Holter, a 7-day diary of motor fluctuations, or self-reported data provided only at the visit (the therapeutic adjustment will be based on the clinical information collected during consultation only).
The primary objective of the study is to determine the efficacy of clinical control in patients with PD according to daily Off time through a diary of motor fluctuations. Secondary outcomes include medical visits and telephone contacts, therapeutic changes, exercise programs, adherence, motor complications, daily On time, freezing of gait episodes, quality of life, autonomy in activities of daily living, and adverse effects.
For their exploratory objective, researchers will study the noninferiority of the Holter for PD symptoms against the diary of motor fluctuations.
One of the main limitations of this study is the potential observer bias due to lack of blinding of the neurologists and potential impact on several secondary outcomes measured by the neurologists.
The findings of this clinical trial, the first to assess the efficacy of a Parkinson Holter to improve motor symptoms in patients with PD, are expected in 2022.
“The results of this study will inform the practical utility of the objective information provided by a [Parkinson] Holter and, therefore, the convenience of adopting this technology in clinical practice and in future clinical trials,” wrote the study researchers.
Disclosure: This research was supported by AbbVie S.L.U. Please see the original reference for a full list of disclosures
Rodríguez-Molinero A, Hernández-Vara J, Miñarro A, et al. Multicentre, randomised, single-blind, parallel group trial to compare the effectiveness of a Holter for Parkinson’s symptoms against other clinical monitoring methods: study protocol. BMJ Open. 2021;11(7):e045272. doi:10.1136/bmjopen-2020-045272