HOPE-MS: Clinical validity of an episodic self-measurement of motor function to assess disease progression in people with multiple sclerosis
Study Description:
This study aims to answer the question of whether signs of multiple sclerosis (MS) can be reliably recorded outside the clinic. The most common MS type is relapsing multiple sclerosis. However, it is also known that a relapse-independent deterioration of functions can occur, e.g. concerning walking ability and balance, which is difficult to detect with conventional methods during the clinical visit. We will investigate whether a self-measurement of such functions at home can be used for this purpose.
In this study, we aim to draw conclusions about symptom progression over two years through various types of observations and compare the following examinations or measurements:
- Investigation using established methods to assess MS during an annual study visit at the study site,
- Assessment of MS with the treating neurologist, and
- Semi-annual measurement of motor functions twice daily for one week, which participants perform themselves at home using a simple measuring device.
The measurement itself consists of given short movement tasks, which are conducted in the measurement room of an infrared camera. The measuring device is made available to the participants for the respective measurement periods and is collected again at the end of the measurement week.
The technical procedure used for the measurement is currently not established in health care, but the measuring device used here is approved as a medical device to support medical observation.
Contact: Clinical Neuroimmunology Outpatient Study Unit at the NCRC.
Studienambulanz-ag-paul@charite.de
Tel. 030 450 539 040
Principal Investigator: PD Dr. med. Tanja Schmitz-Hübsch
Study coordination: Dr. med. Eva-Maria Dorsch
Registration: German Registry for Clinical Studies (DRKS)
Course of the study: 27 months per participant, enrollment planned for spring 2022
Project partners: A company commissioned by the study management is responsible for the provision or delivery of the devices for the self-measurement of motor functions, the technical maintenance, the intermediate storage of raw data, and the calculation of movement parameters from the raw data.
Funding: The conduct of the study is funded by the company celgene/bms. This company has no access to identifying data and, apart from intended publications of results and data, no further access to study data or results of the study.