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

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1 PLEASE NOTE: This trial has been registered retrospectively. Trial Description Title WAKE-Up Pilot Study, Mental Training for patients with relapse-remitting multiple sclerosis and fatigue Trial Acronym [---]* URL of the trial [---]* Brief Summary in Lay Language 60 to 90% of all patients with relapse-remittign multiple sclerosis suffer from chronic fatigue symptoms and cognitive deficits. Tying up to the study of the research group Dr. Grossmann (Neurology 2010) we offer a mindfulness-based group training program to these patients. The training will be done for 6 weeks. Patients are randomized in group A and B. All Patients (group A and B) will undergo a neurological examination and a neuropsychological testing. Group A starts with the training. After the 6-week training all Patients (group A and B) will undergo again the neurological examination and the neuropsychological testing. Then group B starts with the training (cross-over design). After the 6- week training all Patients (group A and B) will undergo again the neurological examination and the neuropsychological testing. Brief Summary in Scientific Language Multiple Sclerosis is the neurological disease which leads most often to persisting impairments and early retirement in young adults. 60 to 90% of all MS patients suffer from fatigue, often in the early stages of the disease. For 15 to 50% of all MS patients, fatigue is of all symptoms the symptom disabling them the most in daily life, regardless of the degree of their physical impaiment. Paients suffer from uncontrollable fatigue, far worse from what they experienced before they were diagnosed with MS. As a consequence their participation in working life and social activities is extremely reduced. So far there is no medication available. Treatment with Amantadin or Modafinil can be discussed on an individual basis. A lot of treatment forms and interventions were tried, but not evaluated in scientific studies. There is a great need for studies which systematically investigate non-medication interventions. The research group of Dr. Grossmann (Neurology 75, 2010 pg ) did a randomized-controlled study with 150 patients. Half of them received best medical treatment, half of them received a group training in addition to best medical treatment. They could prove that such a training can significantly improve quality of life. Tying to these results we offer a mindfulness-based group training program to these patients at the University Hospital of Freiburg, our department of neurology. Compared to the above mentioned study Page 1 of 5

2 we will include only patients with fatigue and we will train and test cognitive functions. Organizational Data DRKS-ID: DRKS Date of Registration in Partner Registry or other Primary Registry: [---]* Investigator Sponsored/Initiated Trial (IST/IIT): yes Ethics Approval/Approval of the Ethics Committee: Approved (leading) Ethics Committee Nr.: 224/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg Secondary IDs Health condition or Problem studied ICD10: G [generalization G35: Multiple sclerosis] Interventions/Observational Groups Arm 1: standard treatment plus a mindfulness-based group training (duration of 6 weeks, once a week for one hour), Arm 2: standard treatment (immunmodulatory medication, physiotherapy) Characteristics Study Type: Interventional Study Type Non-Interventional: [---]* Allocation: Randomized controlled trial Blinding: [---]* Who is blinded: [---]* Control: Active control Purpose: Treatment Assignment: Crossover Phase: N/A Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): N/A Page 2 of 5

3 Primary Outcome 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 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 of recruitment DE Locations of Recruitment University Medical Center Neurologie, Freiburg im Breisgau Recruitment Planned/Actual: Actual (Anticipated or Actual) Date of First Enrollment: 2013/10/09 Target Sample Size: 34 Monocenter/Multicenter trial: Monocenter trial National/International: National Inclusion Criteria Gender: Both, male and female Minimum Age: 18 Years Maximum Age: 60 Years Additional Inclusion Criteria 1. The patient is willing to and physically and mentally capable to participate in the study 2. age 18 up to max. 60 years 3. confirmed diagnosis of relapse remitting multiple sclerosis, accordign McDonald criteria EDSS score of 0 up to max A diagnosis of achronic fatigue-syndrom as a symptom of MS (fatigue questionnaire Page 3 of 5

4 of the MS council as diagnostic tool) 6. severity of fatigue of at least 3 (Fatigue sverity scale) 7. if treatment with immunmodulatign 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 Addresses Primary Sponsor Neurologische Universitätsklinik Freiburg Telephone: [---]* Fax: [---]* [---]* URL: [---]* Contact for Scientific Queries Neurologische Universitätsklinik Ms. M.A. Gisa Schluh gisa.schluh at uniklinik-freiburg.de Contact for Public Queries Neurologische Universitätsklinik Ms. M.A. Gisa Schluh gisa.schluh at uniklinik-freiburg.de Page 4 of 5

5 Sources of Monetary or Material Support Institutional budget, no external funding (budget of sponsor/pi) Neurologische Universitätsklinik Freiburg Mr. Prof. Dr. Sebastian Rauer [---]* Status Recruitment Status: Recruiting ongoing Study Closing (LPLV): [---]* Trial Publications, Results and other documents * This entry means the parameter is not applicable or has not been set. Page 5 of 5

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