Metacognitive and functional Training intervention for patients with MS

Completed (inferred)Relapsing and progressiveISRCTN57222203

What it found

No results found

We found no results in the registry or in papers.

This trial finished 8 years ago. We found no results in the registry or in any paper that cites it.

What it measured

Main measures

  • Perceived cognitive deficits measured using the perceived deficit questionnaire (PDQ) at baseline, 3 weeks, 3, 6 and 12 months.

    Thinking and memory

Other measures (1)

  • 1. Coping and self-efficacy are measured using the Coping Self Efficacy Scale (CSES) at baseline, 3 weeks, 3, 6 and 12 months 2. Fatigue is measured using the Fatigue Scale for Motor and Cognition (FSMC) at baseline, 3 weeks, 3, 6 and 12 months 3. Working Memory is measured using the Corsi-Block-Test / Digit Span backward (Wechsler Memory Scale revised) at baseline, 3 weeks, 3, 6 and 12 months

    Thinking and memoryFatigue

Who could take part

Relapsing and progressive · 18 to 80

Show the full criteria

Inclusion criteria

Inclusion: 1. MS (McDonald-criteria (RRMS, PPMS, SPMS) 2. Expanded Disability Status Scale Score (EDSS) < 6.5) 3. Perceived neuropsychiatric deficits 4. Interest to participate 5. To be in a rehabilitation centre 6. Aged 18-80 years Exclusion: 1. Probable MS 2. Neuromyelitis Optica 3.SDMT < -2,5 SD

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Background and study aims Multiple sclerosis (MS) is one of the most common diseases of the central nervous system (brain and spinal cord). Healthy nerves are coated in a fatty casing (myelin sheath) which helps messages to travel quickly and smoothly along nerves. When a person is suffering from MS, the immune system, which normally helps to protect against infection, attacks the myelin sheath, stripping it from the nerves (demyelination). This demyelination means that messages cannot travel along the nerves effectively, causing a range of problems including loss of vision, problems with balance and coordination as well as fatigue (extreme tiredness), stress and mental health difficulties such as depression. These symptoms can make life very difficult for sufferers, often causing impaired quality of life, social withdrawal or unemployment. The metacognitive and everyday life relevant training for patients with MS (MaTiMS) program is a new training program designed to help improve the coping abilities of MS patients. The aim of this study is to find out whether the MaTiMS program can reduce cognitive deficits in patients with MS with impaired cognitive function. The study will also look at whether MaTiMS is more effective in combination with BrainStim, a computerized training program. Who can participate? Adults with MS who feel they have impaired cognitive function. What does the study involve? Participants are allocated into three groups based on the order that they agree to take part in the study (not randomly). Those in the first group continue to receive the standard care provided by the rehab centre that they attend. Those in the second group take part in the MaTiMS program as well as continuing to receive standard care. The MaTiMS consists of six modules which are taught by a trained facilitator in 1.5 hour long sessions twice a week for three weeks (two modules per week). Those in the third group receive the standard care and the MaTiMS in combination with BrainStim, which involves an additional two 45 minute sessions on a computer twice a week for three weeks. At the start of the study and then again after three weeks and three, six and 12 months, participants in all groups complete a number of questionnaires and memory tests in order to find out if their cognitive deficits have been reduced. What are the possible benefits and risks of participating? Participants who take part in the MaTiMS training could benefit from improved coping abilities and cognitive function. There are no notable risks involved with participating in the study. Where is the study run from? 1. Reha Centrum Hamburg GmbH (Germany) 2. Segeberger Kliniken GmbH (Germany) 3. RehaClinic Quellenhof Bad Wildbad (Germany) When is the study starting and how long is it expected to run for? January 2016 to June 2018 Who is funding the study? German Federal Pension Insurance (Germany) Who is the main contact? Dr Jana Poettgen j.poettgen@uke.uni-hamburg.de

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History

    1. Started

      Apr 2016

    2. Finished

      Jun 2018

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