WAKE-Up Pilot Study, Mental Training for patients with relapse-remitting multiple sclerosis and fatigue

Not Applicable

• Conditions: G35.3; G35.1

• Registration Number: DRKS00005500
• Lead Sponsor: eurologische Universitätsklinik Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-03
• Study Completion: 2016-12-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

1. The patient is willing to and physically and mentally capable to participate in the study
2. age 18 up to max. 65 years 3. confirmed diagnosis of relapse remitting or secondary progressive multiple sclerosis, according McDonald criteria 2010 4. EDSS score of 0 up to max. 5.5 5. A diagnosis of a chronic fatigue-syndrom as a symptom of MS (fatigue questionnaire of the MS council as diagnostic tool) 6. severity of fatigue of at least 4 (Fatigue severity scale) 7. if treatment with immunmodulatory medication, then for at least 6 weeks

Exclusion Criteria

1. no severe or untreated depression or psychiatric disease 2. no chronic sleep disturbances 3. no severe acute concomitant diseases which require acute medical treatment (e.g. tumor or encephalitis) 4. no untreated metabolism disease such as hypothyreosis or dysbalanced electrolytes 5. no anemia (Hb < 12g/dl) or known iron deficits 6. no intake of any sedating medication (analgetics containing opioid or antihistaminica with a sedating effect) 7. no relapse within the last 3 months

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The training can significantly improve the patients' cognitive performance. This will be quanitified with standardized neuropsychological tests before and after 6-week-training: The d2-attention stress test and the VLMT verbal learn and memorizing test

Secondary Outcome Measures

Name	Time	Method
The training can significantly reduce the patients' fatigue symptoms and improve the patients'quality of life. This will be quanitified with standardized questionnaires: fatigue severity scale (FSS) and the SF-36 quality of life questionnaire. The Questionnaire will be filled out before and after the 6-week training