Multiple Sclerosis Clinical Trial
— MS-FatigueOfficial title:
Randomized Controlled Trial on the Efficacy of Acupuncture and the Efficacy of Mindfulness-Based Stress Reduction (MBSR) in Patients With Multiple Sclerosis Suffering From Fatigue
Verified date | January 2016 |
Source | Charite University, Berlin, Germany |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
The main aim of this trial is to evaluate whether additional acupuncture or mindfulness-based stress reduction is more efficacious than usual care only to reduce fatigue in patients with multiple sclerosis.
Status | Completed |
Enrollment | 104 |
Est. completion date | October 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - female or male - 18 to 65 years of age - able to give oral and signed written informed consent - clinical diagnosis of multiple sclerosis - fatigue in "multiple sclerosis" for at least 3 months - other stable pre-study treatment with respect to target symptom fatigue for at least 3 months before inclusion - stable immunomodulatory or immunosuppressive therapy or stable no such a therapy for at least the 3 months before inclusion - fatigue score of =4 on the Fatigue Severity Scale at inclusion - patient's mental and physical ability to participate in the trial - willingness to be randomised, to attend visits, to complete questionnaires, and willingness to participate and fMRI measurements Exclusion Criteria: - fatigue because of a malignant disease - acute relapse or cortisone therapy therapy in the last 30 days before inclusion - EDSS (Extended disability status scale) > 6 - fatigue specific acupuncture in the last 12 months - during the last 12 months performing of MBSR exercises learnt in the past - change of immunomodulatory or immunosuppressive therapy during the 3 months before inclusion - other new therapies are planned which could have a positive effect on fatigue (e.g. exercise, acupuncture, relaxation therapy) - for female patients: pregnancy or anticipated pregnancy during the intervention period - severe acute and or chronic disease which does not allow participation in the therapy - other limitations which do not allow participation in the therapy - alcohol or substance abuse - parallel participation in another clinical trial - BDI > 29 - contra indications for fMRI session (e.g. metal clips) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | The NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | fMRI | e.g. functional connectivity in a subgroup of 20 subjects in each group | baseline, 12 weeks, 26 weeks | No |
Other | Dynamics of saccade parameters | Eye movement analysis will be performed according established standards (Finke et al, J Neurol 2012) | baseline, 12 weeks, 26 weeks, and directly after one acupuncture session | No |
Other | Qualitative interviews regarding therapy | Part of the patients will be interviewed about the therapies. | 26 weeks | No |
Primary | fatigue severity scale | 12 weeks | No | |
Secondary | fatigue severity scale | 26 weeks | No | |
Secondary | modified fatigue impact scale | baseline, 8 weeks, 26 weeks | No | |
Secondary | therapy response rates | 12 weeks | No | |
Secondary | expanded disability status scale | baseline, 12 weeks, 26 weeks | No | |
Secondary | multipe sclerosis functional composite scale | baseline, 12 weeks, 26 weeks | No | |
Secondary | beck depression inventory II | baseline, 12 weeks, 26 weeks | No | |
Secondary | Body efficacy expectation | Body-Efficacy Expectation (BEE) is a scale to measure the conviction that one's body is able to deal with health-threatening factors by itself. It is a six items' scale developed in the Institute of Social Medicine, Epidemiology and Health Economics and not published, yet. | baseline, 12 weeks, 26 weeks | No |
Secondary | SF-12 | baseline, 12 weeks, 26 weeks | No | |
Secondary | HAQUAMS | baseline, 12 weeks, 26 weeks | No | |
Secondary | Costs | Data on Resource-consumption and associated costs are planned to be derived as patient-reported information using the patient questionnaires. | baseline, 12 weeks, 26 weeks | No |
Secondary | overall treatment effect | 12 weeks, 26 weeks | No | |
Secondary | immune parameters | PBMC and proliferationsassays, pro- and antiinflamatory cytokines, axonal damage marker such as neurofilaments and neurotrophic factors like BDNF possible influences on the immune system will be evaluated in an exploratory way. |
baseline, 12 weeks, 26 weeks | No |
Secondary | number of serious adverse events | 12 weeks, 26 weeks | Yes | |
Secondary | number of suspected adverse reactions | 12 weeks, 26 weeks | Yes |
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