Monitoring of Multiple Sclerosis (MS) Participants With the Use of Digital Technology (Smartphones and Smartwatches) - A Feasibility Study
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 2/24/2019 |
| Start Date: | November 28, 2016 |
| End Date: | May 4, 2018 |
This prospective pilot study will assess the feasibility of remote participant monitoring
using digital technology in participants with MS and healthy controls. At the enrollment
visit, the participants as well as the healthy controls will be provided with a remote
patient monitoring solution which includes preconfigured smartphone and smartwatch. The
configured smartphone and smartwatch pair will contain application software that prompts the
user to perform various assessments, referred to as active tests and passive monitoring.
Active tests will include Hand Motor Function Test (HMFT), gait test, static balance test,
electronic version of the Symbol Digit Modalities Test (eSDMT), Mood Scale Question (MSQ), MS
Impact Scale (29-item scale) (MSIS-29) questionnaire, MS Symptom Tracking (MSST). Passive
monitoring will be done to collect metrics on gait and mobility throughout the daily life of
participants in a continuous and unobtrusive manner.
using digital technology in participants with MS and healthy controls. At the enrollment
visit, the participants as well as the healthy controls will be provided with a remote
patient monitoring solution which includes preconfigured smartphone and smartwatch. The
configured smartphone and smartwatch pair will contain application software that prompts the
user to perform various assessments, referred to as active tests and passive monitoring.
Active tests will include Hand Motor Function Test (HMFT), gait test, static balance test,
electronic version of the Symbol Digit Modalities Test (eSDMT), Mood Scale Question (MSQ), MS
Impact Scale (29-item scale) (MSIS-29) questionnaire, MS Symptom Tracking (MSST). Passive
monitoring will be done to collect metrics on gait and mobility throughout the daily life of
participants in a continuous and unobtrusive manner.
Inclusion Criteria:
For MS Participants:
- Definite diagnosis of MS, confirmed as per the revised McDonald 2010 criteria
- Expanded Disability Status Scale (EDSS) of 0.0 to 5.5, inclusive
For All Participants:
- Weight: 45 to 110 kilograms (kg)
Exclusion Criteria:
For MS Participants:
- Severely ill and unstable participants as per investigator's discretion
- Change in dosing regimen or switch of Disease Modifying Therapy (DMT) in the last 12
weeks prior to enrollment
For All Participants:
- Pregnant or lactating, or intending to become pregnant during the study
We found this trial at
2
sites
1500 Owens Street
San Francisco, California 94158
San Francisco, California 94158
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