Safety and Tolerance of an Intermittent Intervention in MS Patients

Universitätsklinikum Hamburg-Eppendorf1 site in 1 country12 target enrollmentSeptember 19, 2018

ConditionsMultiple Sclerosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Multiple Sclerosis
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Enrollment: 12
Locations: 1
Primary Endpoint: Lake Louise Score (LLS)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This observational cohort study investigates the safety and feasibility of an intermittent hypoxia intervention in multiple sclerosis.

Registry

clinicaltrials.gov

Start Date

September 19, 2018

End Date

October 10, 2019

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Responsible Party

Principal Investigator

Prof. Dr. med. Christoph Heesen

Principal Investigator

Universitätsklinikum Hamburg-Eppendorf

Eligibility Criteria

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
•severe cognitive deficits
•chronic headache
•renal insufficiency
•anaemia (Hb \< 10 g/dl)

Outcomes

Primary Outcomes

Lake Louise Score (LLS)

Time Frame: 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 Outcomes

Timed 25-Foot Walk (T25-FW)(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
MRI Lesions(Baseline, at the end of the intervention (after 3 months))
Blood pressure(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
Erythropoetin(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
6 minute walking test (6MWT)(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
Blood count(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
Liver enzymes(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
NFL(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
Expanded Disability Status Scale (EDSS)(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
Symbol Digit Modalities Test (SDMT)(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
Brief Visuospatial Memory Test-Revised (BVMT-R)(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
Brain atrophy(Baseline, at the end of the intervention (after 3 months))
Immune cell subsets(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
Kidney enzyme(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
9-Hole-Peg-Test (9 HPT)(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
Frenchay Activities Index (FAI)(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
Beck Depression Inventory (BDI)(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
Verbal learning and memory test (VLMT)(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
Fatigue Scale Motor Cognition (FSMC)(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
Heart rate(During every session (2hours/session))
Oxygen saturation(During every session (2hours/session))
Blood sugar(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))