Evidence to STAT-ON as a Solution for Early Detection and Awareness of Movement Fluctuations in Parkinson’s Disease

In this 2020 edition of the International Congress of Parkinson’s Disease and Movement Disorders (MDS Congress), that took place for first time in virtual format due to the current situation generated by the COVID-19 pandemic, two posters has been presented by several Spanish neurologists.

Both publications reveal encouraging results regarding the use of new technological solutions for remote monitoring of patients with Parkinson Disease in the clinical practice. In particular, these studies has been implemented with the Holter for Parkinson STAT-ON.

STAT-ON is a medical device class IIa developed and commercialized by Sense4Care, which is capable to perform long-therm monitoring periods at home, using one single device, and without requiring interaction from the patient.

STAT-ON allows the neurologists, and other healthcare professionals, to work on the PD diagnosis with objective and reliable information that give a clear picture of the motor state of the patient, ON and OFF states, Dyskinesia, Bradykinesia, Freezing of Gait, among others, and therefore, contributes to select and tailor the most convenient treatments for every patient.

PUBLICATION 1: EARLY DETECTION OF PARKINSON’S DISEASE MOTOR FLUCTUATIONS WITH A WEARABLE INERTIAL SENSOR

Objective: To assess the utility of a wearable inertial sensor for detecting motor complications in Parkinson’s disease (PD) and its usability.

Background: Identifying motor complications (MC) in daily clinical practice can be challenging and time consuming. Currently, there are wearable inertial sensor devices which have demonstrated high sensitivity and specificity in the detection of motor states and MC that may be useful in clinical practice.

Methods: PD patients diagnosed with PD according to the UK PD Society Brain Bank criteria who routinely visited the Teknon Clinic movement disorders unit were prospectively recruited. Clinical information regarding MC was assessed by UPDRS-IV and clinical evaluation by a PD specialist, before and after wearing the sensor. Patients wore the sensor for one week while doing their daily activities. System Usability Scale (SUS) and Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) scales were used to assess usability of the device.

Results: Thirty-nine patients were included in the study (69±8 years old, 56% males). The mean PD duration was 7±3.9 years and the mean of UPDRS-III ON score was 20.8 ± 9.3. Most of the patients (87%) were in stages 2 and 2.5 of Hoehn and Yahr. All the patients were taking levodopa while 64% received also a dopamine agonist, 64% MAO-B inhibitors, 38% COMT inhibitors and 2% amantadine. Levodopa total daily dose was 565 ± 248 mg.

Seventy-four percent of the patients reported having motor fluctuations (MF), whilst 31% FoG and 54% dyskinesia. According to the information provided by the sensor, 100% of the patients had MF, 61% FoG and 79% dyskinesia. The percentage of patients who reported having MF increased after returning the device (79%). Moreover, according to the PD specialist experience, all patients who still reported not having MF actually presented with them when analyzing clinical symptoms and data provided by the sensor.

Level of satisfaction of the device was high according to QUEST scale. All items scored between 4 “quite satisfied” and 5 “very satisfied” except for the item “easy in adjusting” which had a lower score [Table 1]. When analyzing acceptability of the sensor by the SUS scale, the system was found easy to use [Table 2].

Conclusions: A wearable inertial sensor device can increase awareness of MF among PD patients and help the PD specialist to detect them early. Usability and level of satisfaction of the device is high.

Authors: Nuria Caballol 1,2, Ana Prats 1, Paola Quispe 1, Maria Angels Ranchal 1, Sheila Alcaine 1, Ferran Fondevilla 1, Àngels Bayés 1

1Centro Médico Teknon-Grupo Quirón Salud, Parkinson Unit, Barcelona, Spain, 2Consorci Sanitari Integral, Hospital de Sant Joan Despí Moisés Broggi, Sant Joan Despí, Spain

PUBLICATION 2: USE IN CLINICAL PRACTICE OF A PERSONALIZED AND LONG-TERM MONITORING DEVICE FOR PARKINSON´S DISEASE: STAT-ON

Objective: To analyze the opinion of different neurologists from Spain about the STAT-ON tool after using the device in a real clinical practice setting (RCPS).

Background: The identification of motor fluctuations in Parkinson´s disease (PD) patients is important for PD treatment but not straightforward. STAT-ON is an objective tool that registers ON-OFF fluctuations making possible to know the state of the patient for a week (1,2).

Methods: CE Mark Medical Device STAT-ON was provided by the Company Sense4Care to Spanish neurologists for using it in a RCPS. All neurologists were expert on PD. Each neurologist had the device for at least 3 months and could use it in PD patients at his/her own discretion. In February 2020, a survey with 30 questions was sent to all participants. The data was anonymized and 3 waves were made to obtain the responses.

Results: A total of 27 surveys were received (51.9% females; mean age 44.9 ± 9 years old). Two thirds of the neurologists worked in a Movement Disorders Unit, the mean experience on PD was of 16 ± 6.9 years, and 59.3% of them had used previous different devices for PD. A total of 119 evaluations in 114 patients (range from 2 to 9 per neurologist; mean 4.5 ± 2.3) were performed. Using a score from 1 (unhelpful) to 7 (very helpful), the opinion about different usability aspects was recorded (Table 1). The subjective general opinion about the device (from 0, the worst, to 10, the best) was 6.9 ± 1.7. STAT-ON was considered better than the diaries by 70.3% of the neurologists (Figure 1A) and a useful tool for identification of advanced PD patients by 81.5%. A high percentage of PD patients were considered that could benefit from using STAT-ON (Figure 1B). STAT-ON was considered from quite to very useful by 74% of the neurologists (Figure 1C). A correlation was observed between the number of assessments performed and the opinion about the device (r=0.403; p=0.046). Proper identification of FOG episodes and falls were the most frequent limitations reported.

Conclusions: STAT-ON could be a useful device for using in PD patients in clinical practice.

Authors: Diego Santos García 1, Nuria López Ariztegui 2, Esther Cubo 3, Ana Vinagre Aragón 4, Rosario García Ramos 5, Carmen Borrué 6, Gustavo Fernández Pajarín 7, Nuria Caballol 8, Iria Cabo 9, Jose Barrios López 10, Jorge Hernández Vara 11, Maria Avila 12, Carmen Gasca Salas 13, Sonia Escalante 14, Pablo Manrique 15, Rafael Pérez Noguera 16, María Álvarez Sauco 17, María Sierra 18, Mariana Monje 13, Álvaro Sánchez Ferro 13, Sabela Novo 19, Fernando Alonso 5, Daniel Macías 20, Inés Legarda 21, Ana Rojo 22, Ignacio Fernández 23, María Buongiorno 23, Pau Pastor 23, Pedro García Ruíz 24

1CHUAC (Complejo Hospitalario Universitario de A Coruña), A Coruña, Spain, 2Complejo Hospitalario de Toledo, Toledo, Spain, 3Complejo Asistencial Universitario de Burgos, Burgos, Spain, 4Hospital Donostia, San Sebastián, Spain, 5Hospital Universitario Clínico San Carlos, Madrid, Spain, 6Hospital Infanta Sofía, Madrid, Spain, 7CHUS (Complejo Hospitalario Universitario de Santiago de Compostela), Santiago de Compostela, Spain, 8Consorci Sanitari Integral, Hospital Moisés Broggi, Sant Joan Despí, Barcelona, Spain, 9Complejo Hospitalario Universitario de Pontevedra (CHOP), Pontvedra, Spain, 10Hospital Virgen de las Nieves, Granada, Spain, 11Hospital Universitario Vall d´Hebron, Barcelona, Spain, 12Consorci Sanitari Integral, Hospital General de L´Hospitalet, L´Hospitalet de Llobregat, Barcelona, Spain, 13CINAC, Hospital Puerta del Sur, Madrid, Spain, 14Hospital de Tortosa Verge de la Cinta (HTVC), Tortosa, Tarragona, Spain, 15Clínica Universitaria de Navarra, Pamplona, Spain, 16Hospital Universitario Virgen Macarena, Sevilla, Spain, 17Hospital General Universitario de Elche, Elche, Spain, 18Hospital Universitario Marqués de Valdecilla, Santander, Spain, 19Hospital Universitario Puerta de Hierro, Madrid, Spain, 20Hospital Universitario Virgen del Rocío, Sevilla, Spain, 21Hospital Universitario Son Espases, Palma de Mallorca, Spain, 22Hospital Universitario Príncipe de Asturias, Madrid, Spain, 23Hospital Universitari Mutua de Terrassa, Barcelona, Spain, 24Hospital Fundación Jiménez Díaz, Madrid, Spain