WAKE-Up Pilot Study, Mental Training for patients with relapse-remitting multiple sclerosis and fatigue
Organizational Data
- DRKS-ID:
- DRKS00005500
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2013-12-03
- Last update in DRKS:
- 2022-06-23
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
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 1141-1149) 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 we will include only patients with fatigue and we will train and test cognitive functions.
Health condition or problem studied
- ICD10:
- G35.1
- ICD10:
- G35.3
- Healthy volunteers:
- No Entry
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)
Endpoints
- 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
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Crossover
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Neurologie Freiburg im Breisgau
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2013-10-09
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2016-12-03
- Target Sample Size:
- 34
- Final Sample Size:
- 23
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 65 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. 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
Addresses
Primary Sponsor
- Address:
- Neurologische Universitätsklinik Freiburg79106 FreiburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Neurologische UniversitätsklinikGisa SchluhBreisacher Str. 6479106 FreiburgGermany
- Telephone:
- 0761-270-50010
- Fax:
- 0761-270-53900
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.neurologie-uniklinik-freiburg.de/
Contact for Public Queries
- Address:
- Neurologische UniversitätsklinikGisa SchluhBreisacher Str. 6479106 FreiburgGermany
- Telephone:
- 0761-270-50010
- Fax:
- 0761-270-53900
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.neurologie-uniklinik-freiburg.de/
Principal Investigator
- Address:
- Neurologische UniversitätsklinikGisa SchluhBreisacher Str. 6479106 FreiburgGermany
- Telephone:
- 0761-270-50010
- Fax:
- 0761-270-53900
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.neurologie-uniklinik-freiburg.de/
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Neurologische Universitätsklinik FreiburgBreisacher Str. 6479106 FreiburgGermany
- Telephone:
- 0761-270-50010
- Fax:
- 0761-270-53900
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.neurologie-uniklinik-freiburg.de/
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Albert-Ludwigs-Universität FreiburgEngelberger Str. 2179106 FreiburgGermany
- Telephone:
- +49-761-27072600
- Fax:
- +49-761-27072630
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2013-05-27
- Ethics committee number:
- 224/13
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2013-06-04
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Ergebnisbericht
- Schluh G (2018) Wake-up pilot study for patients with multiple sclerosis and fatigue: How mindfulness can help? Neuro Neurosurg. 1(1): DOI: 10.15761/NNS.1000103
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry