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)

F. Hoffmann-La Roche Ltd0 个研究点目标入组 279 人开始时间: 2022年3月11日最近更新: 2024年8月5日

适应症

试验速览

暂无简介。

•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
•2. Aged 18 years or older
•3. EDSS in the range of 2.0 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.

•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.

发起方