ISRCTN62225263
Completed
未知
A prospective investigation of the feasibility of smartphone-based self-monitoring to characterize cognitive and neurological impairment in patients with multiple sclerosis (Floodlight MS_More Active)
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Multiple sclerosis
- Sponsor
- F. Hoffmann-La Roche Ltd
- Enrollment
- 279
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current participant inclusion criteria as of 21/12/2023:
- •1\. Be able to provide informed consent to the study, and to participate in the MSBase registry and the MRI repository
- •2\. Aged 18 years or older
- •3\. EDSS in the range of 1\.0 to 7\.0 inclusive
- •4\. Diagnosis of MS (new or revised) based on the 2017 revised McDonald criteria
- •5\. Untreated or treated with an approved or off\-label DMT, if DMT was initiated \>3 months ago
- •6\. Must have a personal smartphone
- •7\. Willing to discontinue participation in any other Floodlight application.
- •Previous participant inclusion criteria:
- •1\. Be able to provide informed consent to the study, and to participate in the MSBase registry and the MRI repository
Exclusion Criteria
- •1\. Unable to provide data to establish a minimum dataset
- •2\. Any contraindication for use of smartphone as per the investigator’s discretion
- •3\. Known significant cognitive impairment as per the investigator’s discretion
- •4\. Not able to tolerate routine clinical MRI
- •5\. Clinical relapse in the 30 days before enrolment.
Outcomes
Primary Outcomes
Not specified
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