Background: There is rising interest in remote clinical trial assessments, particularly in the setting of the COVID-19 pandemic. Objective: To demonstrate the feasibility, reliability, and value of remote visits in a phase III clinical trial of individuals with Parkinson’s disease. Methods: We invited individuals with Parkinson’s disease enrolled in a phase III clinical trial (STEADY-PD III) to enroll in a sub-study of remote video-based visits. Participants completed three remote visits over one year within four weeks of an in-person visit and completed assessments performed during the remote visit. We evaluated the ability to complete scheduled assessments remotely; agreement between remote and in-person outcome measures; and opinions of remote visits. Results: We enrolled 40 participants (mean (SD) age 64.3 (10.4), 29% women), and 38 (95%) completed all remote visits. There was excellent correlation (ICC 0.81–0.87) between remote and in-person patient-reported outcomes, and moderate correlation (ICC 0.43–0.51) between remote and in-person motor assessments. On average, remote visits took around one quarter of the time of in-person visits (54 vs 190 minutes). Nearly all participants liked remote visits, and three-quarters said they would be more likely to participate in future trials if some visits could be conducted remotely. Conclusion: Remote visits are feasible and reliable in a phase III clinical trial of individuals with early, untreated Parkinson’s disease. These visits are shorter, reduce participant burden, and enable safe conduct of research visits, which is especially important in the COVID-19 pandemic.

Background:The Unified Huntington's Disease Rating Scale (UHDRS) is the principal means of assessing motor impairment in Huntington disease but is subjective and generally limited to in-clinic assessments.Objective: To evaluate the feasibility and ability of wearable sensors to measure motor impairment in individuals with Huntington disease in the clinic and at home.Methods: Participants with Huntington disease and controls were asked to wear five accelerometer-based sensors attached to the chest and each limb for standardized, in-clinic assessments and for one day at home. A second chest sensor was worn for six additional days at home. Gait measures were compared between controls, participants with Huntington disease, and participants with Huntington disease grouped by UHDRS total motor score using Cohen's d values.Results: Fifteen individuals with Huntington disease and five controls completed the study. Sensor data were successfully captured from 18 of the 20 participants at home. In the clinic, the standard deviation of step time (time between consecutive steps) was increased in Huntington disease (p<0.0001; Cohen's d=2.61) compared to controls. At home with additional observations, significant differences were observed in seven additional gait measures. The gait of individuals with higher total motor scores (50 or more) differed significantly from those with lower total motor scores (below 50) on multiple measures at home.Conclusions: In this pilot study, the use of wearable sensors in clinic and at home was feasible and demonstrated gait differences between controls, participants with Huntington disease, and participants with Huntington disease grouped by motor impairment.

Background: Parkinson’s disease (PD) motor symptoms can fluctuate and may not be accurately reflected during a clinical evaluation. In addition, access to movement disorder specialists is limited for many people with PD. The objective of this study was to assess the impact of motion sensor-based telehealth diagnostics on PD clinical care and management. Methods: Eighteen adults with PD were randomized to control or experimental groups. All participants were instructed to use a motion sensor-based monitoring system at home 1 day per week for 7 months. The system included a finger-worn motion sensor and tablet-based software interface that guided patients through tasks to quantify tremor, bradykinesia, and dyskinesia. Data were processed into motor symptom severity reports, which were reviewed by a movement disorder neurologist for the experimental group participants. After 3 months and 6 months, the control group participants visited the clinic for a routine appointment, while the experimental group participants had a videoconference or phone call instead. Results: Home-based assessments were completed with a median compliance of 95.7%. For a subset of participants, the neurologist successfully used information in the reports, such as quantified responses to treatment or progression over time, to make therapy adjustments. Changes in clinical characteristics from study start to end were not significantly different between the groups. Discussion: Individuals with PD were able and willing to use remote monitoring technology. Patient management aided by telehealth diagnostics provided comparable outcomes to standard care. Telehealth technologies combined with wearable sensors have the potential to improve care for disparate PD populations or those unable to travel.

NCT02144220.