Multiple Sclerosis
Conditions
Brief summary
This observational cohort study investigates the safety and feasibility of an intermittent hypoxia intervention in multiple sclerosis.
Interventions
None listed
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 18-60 years * confirmed MS (all types of MS) * ability to come to the outpatient clinic 2-3x/week for 3 months * EDSS ≤ 6.5 * inconspicuous medical examination * inconspicuous ECG
Exclusion criteria
* relapse in the last 3 months * EDSS progression in the last 6 months * pregnancy * contraindication for MRI * severe heart disease * severe asthma, COPD * cancer * severe cognitive deficits * chronic headache * renal insufficiency * anaemia (Hb \< 10 g/dl) * insulin-dependent diabetes mellitus * severe vascular stenosis * former episodes of severe high mountain sickness * cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lake Louise Score (LLS) | Change of mean LLS before vs. after 1 hour vs. after 2 hours of each session | Tolerance by measuring the development of acute mountain sickness during the sessions Score 3 to 5 = mild AMS Score 6 or more = severe AMS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timed 25-Foot Walk (T25-FW) | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) | Quantitative mobility and leg function performance test based on a timed 25-walk |
| 6 minute walking test (6MWT) | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) | Maximum distance in 6 minutes |
| 9-Hole-Peg-Test (9 HPT) | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) | Quantitative test of upper extremity function |
| Verbal learning and memory test (VLMT) | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) | Rapid and delayed recall |
| Symbol Digit Modalities Test (SDMT) | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) | Test for concentration and decision making |
| Brief Visuospatial Memory Test-Revised (BVMT-R) | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) | Test for visuospatial memory |
| Frenchay Activities Index (FAI) | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) | Measure of instrumental activities of daily living (IADL) |
| Fatigue Scale Motor Cognition (FSMC) | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) | Measure MS-related cognitive and motor fatigue in MS * 43 Mild Fatigue * 53 Medium Fatigue * 63 Severe Fatigue |
| Beck Depression Inventory (BDI) | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) | Measure severity of depression |
| MRI Lesions | Baseline, at the end of the intervention (after 3 months) | T2 and Gd enhancing T1 lesions |
| Expanded Disability Status Scale (EDSS) | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) | MS impairment measurement with a score ranging from 0.0 (normal neurological exam) to 10.0 (death due to MS) |
| Immune cell subsets | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) | FACS analysis |
| Heart rate | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) | bpm by pulsoxymeter |
| Blood pressure | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) | mmHg |
| Oxygen saturation | During every session (2hours/session) | measured by pulsoxymeter |
| Blood sugar | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) | mg/dl in the blood sample |
| Blood count | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) | Hb, Hct, Leucocytes, Lymphocytes, Thrombocytes, Neutrophils in th blood sample |
| Erythropoetin | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) | blood sample |
| Liver enzymes | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) | GOT, GPT, GGT (blood sample) |
| Kidney enzyme | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) | Creatinine (blood sample) |
| NFL | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) | Neurofilament light chain (serum) |
| Brain atrophy | Baseline, at the end of the intervention (after 3 months) | MRI |
Countries
Germany
Outcome results
None listed