G35
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: People with any MS phenotype according to the revised McDonald’s criteria; aged 18 years or over; any ethnicity; disability status score on the EDSS of 2.0 to 5.0; stable disease; no evidence of disease activity; and able to speak and understand German language. Healthy controls for the fMRI scanning: 15 age- and gender matched healthy controls without any history of neurological, psychiatric, orthopaedic or other disorder.
Exclusion criteria
Exclusion criteria: People with MS with concomitant diseases (such as malignant diseases, other neurological or psychiatric disorders, musculoskeletal problems affecting walking, pain, uncorrected visual or hearing impairment); cognitive impairment as defined by a MoCA cut-off score of 26/30 (<26 = impaired cognition; =26 = intact cognition); anxiety or depression as signified by a HADS anxiety subscale score of 11/21 or a depression subscale score of 11/21 or suicidality as evaluated by a narrative screening; pregnancy; a relapse of MS within the last three months; any medication initiation or change (including corticosteroids) or any physiotherapy change within three months prior to the study; any change of symptomatic treatment affecting walking (medication or physiotherapy) or of disease modifying treatment (DMT) during the study will lead to an exclusion of the participant from the further analysis. Any MRI/fMRI contraindications, e.g. implanted ferrous metal, heart pacemaker or claustrophobia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Walking speed as assessed by the Timed 25-Foot Walk (T25FW) 2. Walking distance as assessed by the 2-Minute Walk Test (2MWT) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Brain activation patterns, as measured by functional magnetic resonance imaging (fMRI), of patients and healthy controls at baseline compared to post-intervention (after 4 weeks) 2 MS-related fatigue, as measured by the validated German version (NFI-MS-G) of the Neurological Fatigue Index (NFI-MS) 3 MS-related health-related quality of life, as assessed by the validated German version of the Multiple Sclerosis International Quality of Life (MusiQol) questionnaire 4 Ability to imagine movement/motor imagery, as assessed by the validated German version of the Kinaesthetic and Visual Imagery Questionnaire, short version (KVIQ-10) 5 Ability to imagine movement/motor imagery, as assessed by a mental chronometry test (comparison of the duration of imagined and actual walking a distance of six meters) 6 Anxiety and depression, as assessed by the validated German version of the Hospital Anxiety Depression Scale (HADS); additionally, narrative screening for suicidality 7 Global cognitive impairment, as assessed by the validated German version of the Montreal Cognitive Assessment (MoCA) 8 Music-induced motivation/motivational quality of music, as assessed by the Brunel Music Rating Inventory-2 (BMRI-2) 9 Music-induced enjoyment/pleasure, as assessed by the pictorial Self-Assessment Manikin (SAM) 10 MS-specific self-efficacy, as assessed by the validated German version (USE-MS-G) of the Unidimensional Self-Efficacy Scale for MS (USE-MS) 11 Cognitive function or impairment, as assessed by the Symbol Digit Modalities Test (SDMT) | — |
Countries
Austria
Contacts
Medizinische Universität Innsbruck Universitätsklinik für Neurologie