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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00005500
Enrollment
34
Registered
2013-12-03
Start date
2013-10-09
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G35.1 G35.3

Interventions

Group 1: standard treatment plus a mindfulness-based group training (duration of 6 weeks, once a week for one hour), Group 2: standard treatment (immunmodulatory medication, physiotherapy)

Sponsors

Neurologische Universitätsklinik Freiburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Germany

Contacts

Public ContactGisa Schluh

Neurologische Universitätsklinik

gisa.schluh@uniklinik-freiburg.de0761-270-50010

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026