VR-based Dexterity Training in MS

Home-based Virtual Reality (VR) Headset-based Dexterity Training in Multiple Sclerosis: a Randomized-controlled Trial

The aim of the study is to investigate if a specifically developed home-based dexterity training intervention using a Virtual Reality (VR) Headset (Meta quest 2) improves impaired manual dexterity in persons with multiple sclerosis.

Subjects will be recruited during regular visits at the MS centre of the Luzerner Kantonsspital, Switzerland or at the Department of Neurology of the University Hospital Basel. Ethical approval will be obtained, and the trial will be registered in the clinicaltrials.gov database. Patients must sign informed consent prior to study entry (=Screening). If patients are eligible at screening as defined in the Inclusion- and Exclusion criteria, all primary and secondary outcome measurements will be performed at Baseline. Subjects will be randomized 1:1 in Group 1 (Training intervention) or Group 2 (Sham-Intervention) and instructed into the respective training. After 4 weeks of training, all primary and secondary outcome measurements will be repeated, and the study ends.

Inclusion Criteria:

• MS patients with relapsing-remitting MS (RRMS), secondary-progressive MS (SPMS) or primary progressive MS (PPMS) according to the revised McDonald's criteria (Thompson et al. 2017)
• Age between 18 and 75 years
• Written informed consent signed by the subject must be obtained prior to study start
• Patient must complain about MS related impaired manual dexterity negatively affecting ADL and/or QoL
• Patients must have Arm function in multiple sclerosis questionnaire (AMSQ) score >41

Exclusion Criteria:

• A relapse that started within 60 days prior to screening
• Rapidly progressive disease
• Any disease/condition that impaired manual dexterity besides MS
• Any disease other than MS that could possibly explain the patient's signs and symptoms
• Medical or psychiatric conditions that compromise the ability to comply with the protocol, or to complete the study
• History of epilepsy or epileptic seizures
• A history of drug abuse in the 12 months prior to screening