Current studies

This progression investigation is oriented towards patients who have only been suffering from multiple sclerosis for a short period of time or who have been diagnosed with so-called "clinically isolated syndrome" (CIS). This is an observational study which is intended to help the understanding of the disease in its earlier stages and to develop markers for progression and prognosis. At regular intervals, the study participants receive, among other things, a neurological examination, an MRT examination and optical coherence tomography.

Study Director: Prof. Dr. Friedemann Paul (WG Clinical Neuroimmunology, NCRC, ECRC)

In this study, we investigate whether the regular high-dose intake of vitamin D positively impacts the clinical course and various MRI parameters in patients with relapsing-remitting MS or even clinically isolated syndrom. A number of studies suggest that the blood level of vitamin D can influence both the disease risk and course of MS. However, it is unclear whether this also applies to the intake of vitamin D. A unique feature of this study is that, in contrast to the more frequent placebo-controlled In one study group the patients receive a so-called placebo. This is an imitation medication that looks like the study medicine but does not contain any active agent. trials, two different dosages of vitamin D are compared. This means that all study participants receive vitamin D. Participation is open to male and female patients who have received MS treatment with interferon-β1b for at least the last three months. The study drug is taken orally every two days over a period of 1.5 years and is very well tolerated. Treatment with interferon-β1b will be continued during the study. Patients will be seen and examined regularly in the study outpatient clinic.

Study Director: Dr. Jan Dörr (WG Clinical Neuroimmunology, NCRC)

This is a follow-up study involving the critical flicker frequency (CFF). CFF is the repetition frequency of a blinking light signal at which the temporal resolution ability of the eye can distinguish individual light signals. In other words, the CFF describes the frequency at which a person no longer perceives continuous light but rather a flickering signal. In this research project we investigate whether the CFF in MS patients differs from that of healthy individuals, and also whether the CFF in MS patients correlates with measurable damage to nerve fibers. There will be three visits during this 1.5-year study, including a neurological examination, optical coherence tomography and an examination of the CFF. This study is open to patients with relapsing-remitting MS.

Study Director: Dr. Jan Dörr (WG Clinical Neuroimmunology, NCRC)

Many MS patients suffer from inflammation of the optic nerve at the beginning or in the course of their disorder, which often leads to a permanent damage of the nerve fibre or nerve cells. Besides its anti-inflammatory effect, the newly approved MS-treatment Gilenya® might also have a neuroprotective component. In the MOVING study we want to investigate whether an early treatment with Gilenya® might lead to a measurable reduction of neural damage compared to a standard therapy with Interferon beta.

Study duration is 6 months. Patients with relapsing-remitting MS or CIS, who recently suffered from an optic nerve inflammation can participate. Participants are seen regularly in our study outpatient clinic. Study visits include magnetic resonance imaging (MRI) and several optic examinations.

Study Director: Dr. Olaf Hoffmann (WG Clinical Neuroimmunology, NCRC) in cooperation with Prof. Dr. Friedemann Paul (WG Clinical Neuroimmunology, NCRC, ECRC)

Good measuring instruments are necessary to describe the benefits and harms of various therapies, whether for symptom relief or influence on the MS itself. Currently, the main standard accepted worldwide is the EDSS, the Expanded Disability Status Scale. The aim of this study is to examine patient-based investigation instruments, especially questionnaires and new objective tests, in particular a walking endurance test and eyesight check. We will examine to what extent these tools show the activity of the disease better than traditionally used instruments. Participation is open to patients with high disease activity, as well as patients without relapses and without an increase in EDSS in the last two years. Patients will be seen at the study outpatient clinic every three months for various tests and examinations.   

Study Director: Prof. Dr. Friedemann Paul (WG Clinical Neuroimmunology, NCRC, ECRC)

Recent data suggest that an asymptomatic worm infection by the pig whipworm can reduce disease activity of autoimmune disorders. We want to investigate this approach in the TRIOMS study in patients with relapsing-remitting MS or Clinically Isolated syndrome (CIS). One group of study participants will regularly take in a liquid containing purified pig whipworm eggs for one year. The other group will receive an identically appearing placebo liquid. Efficacy will for the main part be measured by magnetic resonance imaging (MRI). Previous data suggest a very good tolerability of the eggs.

Patients with relapsing-remitting MS or CIS, who do not tolerate standard treatments with interferons or glatirameracetate, or in which these are not effective can participate in this study. Participants are seen regularly in our study outpatient clinic.

Study Director: Dr. Berit Rosche (Departement of Neurology) in cooperation with Prof. Dr. Friedemann Paul (WG Clinical Neuroimmunology, NCRC, ECRC)

NMO (also known as Devic's syndrome),is a rare inflammatory autoimmune disease of the central nervous system, which affects almost exclusively the optical nerves and spinal cord. The neuromyelitis optica study group (called NEMOS in the following) is an initiative by doctors from about 25 hospitals all over Germany which has set itself the aim of extending knowledge about the NMO and thereby improving the diagnosis and therapy of patients affected by this disease. In this project it is intended to gather, from the NMO patients who have given their consent to this undertaking, important information on diagnosis, course and treatment in pseudonymized form in a databank. For better understanding of the disease processes in NMO patients we would also like to carry out targeted MRT examinations, tests on cognitive ability and an optical coherence tomography. Participation is open to all patients who have been diagnosed with neuromyelitis optica and/or Devic's syndrome.

You can find further information on the NEMOS Study Group and on neuromyelitis optica here: http://www.nemos-net.de/

Study Director: Prof. Dr. Friedemann Paul (WG Clinical Neuroimmunology, NCRC, ECRC)

Susac's syndrome is a rare disease affecting the brain, the retina of the eye and the inner ear. This leads, among other things, to cognitive impairments, personality changes, paralytic symptoms, impaired vision and reductions of hearing. The precise cause of Susac's syndrome is not known. In this research project, the intention is firstly to find biomarkers that enable a reliable diagnosis of Susac's syndrome and differentiation from other, usually much more frequent disease. The second aim is to improve knowledge and understanding of the fundamental harmful processes. A certain diagnosis and a better understanding of the harmful mechanisms are ultimately the key to an effective treatment. Participation is open to all patients in whom Susac's syndrome has been ascertained or supposed.

Study Director: Dr. Jan Dörr (WG Clinical Neuroimmunology, NCRC)

Stroke leads in the short-term to a substantial reduction in the functional ability of the immune system (stroke-induced immunodeficiency - CIDS). This encourages the occurrence of infections (e.g. pneumonia). On the other hand, the destruction of the brain tissue by the stroke can also favor the arising of autoimmune mechanisms. In such a case, the immune system attacks the body's own tissues. In this study, we want to show whether the stroke leads to the arising of autoimmune mechanisms and what influence these have upon the clinical course of the disease after the stroke. In the framework of this study, blood is taken from patients who have suffered a moderately severe to severe stroke, directly after inclusion in this study within 36 hours, after three, seven, 90 and 180 days after the stroke and tested for immunological changes. In addition, thorough clinical examinations are carried out.

Study Director: Dr. Juliane Klehmet (WG Cerebrovascular Diseases, NCRC, Neurology CCM)

In these projects, patients who have suffered paralysis (motor paresis) or a language disorder (aphasia) following stroke are examined through intensive physiotherapeutic training as well as a combination of physiotherapeutic training and transcranial direct current stimulation or through highly intensive individually customized naming training as well as a combination of intensive naming training and transcranial direct current stimulation. At the same time, the underlying mechanisms will be recorded through structural and functional imaging techniques (as well as single-pulse transcranial magnet stimulation).

Study Director: Prof. Dr. Agnes Flöel (WG Cognitive Neurology, NCRC, CSB, Neurology CCM)

Neglect is a common syndrome after a stroke. Patients with neglect no longer perceive stimuli which are spatially contra lateral to the damaged hemisphere of the brain. In daily life this leads to serious limitations. Moreover, the occurrence of neglect is a negative predictor for expected patient recovery.

Currently, in addition to observing spontaneous behaviour, cross-out tasks (“paper and pencil” tests) are the main means of diagnosing neglect. The downside of these tasks is that they only test a small spatial area. In the first phase of the project (KMS-1 pilot study), we could increase diagnostic accuracy with an encircling-monitor-system which consists of touch screens on which tasks can be presented and solved. We could detect even mild symptoms which are not picked up by traditional tests but can be relevant in complex daily life situations. This makes goal-oriented treatment possible for affected patients. In the long term, we also want to use this technology to improve therapy for neglect patients by modelling tasks from everyday life.  

Based on our study KMS-1 we now want to test healthy participants, after inducing short-term neglect symptoms by means of non-invasive brain stimulation (tDCS). Contrarily to other stroke caused impairments like speech disorders or visual field defects, it is yet insufficiently examined which lesion locations are responsible for the different manifestations of neglect. The reason is that patients with neglect usually have widely spread lesions which have impaired many areas of the brain.  tDCS gives the opportunity to stimulate specific brain regions and to examine their selective impact on the neglect symptoms. tDCS is without risk and does not lead to any negative sensations or permanent cognitive or sensory restrictions. A selective examination of the underlying mechanisms and involved structure-function-correlations in neglect would help to understand this syndrome and could positively affect the diagnostics and therapy and therefore chances of rehabilitation of these patients.

Study Director: Prof. Dr. Andreas Meisel (WG Cerebrovascular Diseases, NCRC, CSB, Neurology CCM)

Contact persons: Dr. Lena Ulm, Dorota Wohlrapp (MS) (WG Cerebrovascular Diseases, NCRC, Neurology CCM)

Participating cooperation partners: NeuroCure Cluster of Excellence (Prof. Dr. Agnes Flöel , Prof. York Winter), Median Klinik Berlin-Kladow (Dr. Christian Dohle), Freie Universität Berlin, Department of Experimental Psychology and Neuropsychology (Prof. Michael Niedeggen), Berlin Center for Advanced Neuroimaging BCAN, and the graduate school Berlin School of Mind and Brain (Dr. Daniel S. Margulies).

If damage occurs in a particular region of the brain, related changes in nerve cell structures can sometimes also be detected in other, more distant regions of the brain. The object of this study is the presentation of a possible involvement of the frontal sections of the visual system (retina) in patients who have suffered a stroke involving the rear sections of the visual system. The examinations carried out here on patients with optical coherence tomography could provide an important contribution to the understanding of the functioning of the visual system. 

This study is oriented primarily towards patients with newly occurred strokes in the basin of the posterior cerebral artery. Participation is also open to patients with circumscribed small "lacunary“ infarcts in other areas of the brain. 

Study Director: Prof. Dr. Friedemann Paul (WG Clinical Neuroimmunology, NCRC, ECRC)

PREDICT is an observation study on the predictive power of clinical parameters and bio-markers regarding stroke-associated pneumonia. This is intended to allow targeted prevention of this life-threatening complication in stroke patients. You can find more detailed information here. 

Study Director: Prof. Dr. Andreas Meisel (WG Cerebrovascular Diseases, NCRC, CSB, Neurology CCM)

The development of stroke-associated infections has a negative influence on the outcome, i.e. the course of the disease after the stroke. The early identification of high-risk patients, made possible by biomarkers, could lead to an improvement of outcomes after a stroke due to the early starting of antibiotic therapy. With this study, we would like to investigate whether intensive infection monitoring by means of Procalcitonin ultrasensitive (PCTus) not only permits early and targeted treatment with antibiotics, but can also improve the functional outcome after a stroke - in comparison with a standard therapy based on the current guidelines.

This is a multicenter, randomized The allocation to the treatment group is purely random., double-blind Neither the patients nor the doctor know whether the patient is receiving the study medication or the placebo (or fotr studies without medication: to which study arm the patient has been allocated). study.

Study Director: Prof. Dr. Andreas Meisel (WG Cerebrovascular Diseases, NCRC, CSB, Neurology CCM)

The course and degree of severity of myasthenia gravis (MG) vary greatly from individual to the next. To date there have been no clinical, genetic or immunological markers that permit a prediction of the form the myasthenia will take and thus a prognosis. By means of the myasthenia cohort, prognostic parameters are to be identified that allow the course (ocular, generalized, myasthenic crisis), the response to treatment (pyridostigmine, steroids, immunosuppressants, thymectomy) and the long-term course to be predicted early on. In addition, biomarkers are to be identified which predict disease activity (remissions and/or exacerbation of the disease). Furthermore, new scientific hypotheses and findings are to be investigated on the basis of the study population, which is to be systematically examined for a period of ten years and is expected to be very well defined, both clinically and paraclinically.

Study Director: Prof. Dr. Andreas Meisel (WG Cerebrovascular Diseases, NCRC, CSB, Neurology CCM)

Although the association between expansion or a tumor of the thymus and autoimmune myasthenia gravis has already been known for a long time, the cause and effect of this link continues to be unexplained. With this study, we are hoping for new findings on the occurrence of myasthenia and the autoantibody formation associated with it. Moreover, we would like to investigate the effects of a removal of the thymus upon the immune system in the context of myasthenia gravis. For this purpose, we are examining myasthenia patients with and without thymus tumor and thymus tumor patients without myasthenia before and after operative removal of the thymus gland.

Study Director: Dr. Siegfried Kohler (AG Cerebrovascular Diseases, NCRC, Neurology CCM)

The course and degree of severity of chronic-inflammatory demyelinating polyneuropathy (CIDP) vary greatly among individual cases. Especially in younger patients (approx. 30% of cases), relapse remitting courses can be observed. To date there have been no clinical, genetic or immunological markers that permit prediction of the course of the disease and thus a prognosis of the CIDP. By means of the CIDP Cohort it is intended to identify prognosis parameters can predict the course of the disease, but also the therapeutic response to therapy and the long-term outcome early on. In addition, biomarkers are to be identified that predict the disease activity (remissions and/or exacerbation of the disease). Furthermore, new scientific hypotheses and findings are to be investigated on the basis of the study population, which is to have been systematically examined for a period of ten years and is expected to be very well characterized.

Study Director: Dr. Juliane Klehmet (WG Cerebrovascular Diseases, NCRC, Neurology CCM)

5% of all children suffer from at least one febrile seizure once in their lifetime. 30% of these children have recurrent or particularly long-lasting febrile seizures which is very incriminating for affected parents. The current standard therapy consists in the rectal administration of diazepam in cases where the seizure lasts longer than 3 minutes. Unfortunately, this substance is not always effective. Furthermore, it has a sedating effect, i.e. after administration the children usually sleep for the rest of the day or are dazed. 

Previous work showed that the inhalation of an increased carbon dioxide concentration could stop febrile seizures quickly. We now want to confirm these findings in a bigger randomized The allocation to the treatment group is purely random., placebo-controlled In one study group the patients receive a so-called placebo. This is an imitation medication that looks like the study medicine but does not contain any active agent., double-blind Neither the patients nor the doctor know whether the patient is receiving the study medication or the placebo (or fotr studies without medication: to which study arm the patient has been allocated). study using carbogen (containing 5% carbon dioxide and 95% oxygen). All previous data show a very high safety of carbogen. Carbogen will be administered via a low pressure can (similar to a spray can). Participating patients will receive these cans for the use at home.

Study Director: Prof. Dr. Markus Schülke-Gerstenfeld (WG Developmental Disorders of the Nervous System, NCRC, Pediatrics CVK)

The new sequencing techniques will, in a few years, make it possible to sequence the genome of every person for 1,000 US dollars (i.e. to read the succession of 3 billion base pairs). In this, one will inevitably encounter numerous variations, the overwhelming majority of which are benign and only reflect the differences between people. We are continually developing and improving software which we make freely available via the Internet and which makes it possible for doctors and researchers to analyze these genetic variations automatically and to distinguish between benign and pathological changes. This simplifies the search for "a needle in a haystack". You can find more detailed information here. The software is available via http://www.genedistiller.org and http://www.mutationtaster.org

Study Director: Prof. Dr. Markus Schülke-Gerstenfeld (WG Developmental Disorders of the Nervous System, NCRC, Pediatrics CVK)

With this study we would like to identify genes with mutations that lead to a disease pattern in which the children are already akinetic in the womb and are therefore born with stiff joints. To achieve this, we are ascertaining the base sequences of genes that play a role in the development of the muscular and nervous system.

Study Director: Prof. Dr. M. Schülke-Gerstenfeld (WG Developmental Disorders of the Nervous System, NCRC, Pediatrics CVK)

This study is devoted to explaining the genetic causes of West syndrome, a severe form of epilepsy that occurs in infancy and early childhood. The investigation consists of genetic mapping and gene sequencing in affected patients and their families. With these investigations, we hope to uncover the causes that will in future enable a causal therapy.

Study Director: Prof. Dr. Markus Schülke-Gerstenfeld (WG Developmental Disorders of the Nervous System, NCRC, Pediatrics CVK)

Three to five percent of all people have a febrile seizure at least once in their lives. Despite the frequency of this disease, the pathophysiological and genetic causes are still unexplained. Based upon investigations on an animal model, which suggests disrupted respiratory regulation as a possible cause, we are conducting a clinical study in which we are testing this hypothesis on humans. In the study, children are continually monitored during the night after a febrile seizure, as regards their breathing rate, body temperature, oxygen saturation and carbon dioxide partial pressure. Children who have fever but have not suffered a febrile seizure serve as a control group.

Study Director: Prof. Dr. M. Schülke-Gerstenfeld (WG Developmental Disorders of the Nervous System, NCRC, Pediatrics CVK)

In this study, which is being carried out in close cooperation with the Social Pediatric Center (SPZ) for Neuropediatrics at the Charité-Campus Virchow Klinikum (CVK) and the Clinic for Child and Adolescent Medicine of the DRK Kliniken Berlin Westend, we are investigating whether the regular taking of the extract of green tea (epigallocatechin gallate, EGCG) positively influences the progression of disability of patients with Duchenne muscular dystrophy. This is a multi-center A study, which is carried out at several centers., randomized The allocation to the treatment group is purely random., placebo-controlled In one study group the patients receive a so-called placebo. This is an imitation medication that looks like the study medicine but does not contain any active agent., double-blind Neither the patients nor the doctor know whether the patient is receiving the study medication or the placebo (or fotr studies without medication: to which study arm the patient has been allocated). study. Participation is open to male patients from the age of five who have been diagnosed with Duchenne muscular dystrophy. The study medicine is taken twice a day as a capsule.

Study Director: Prof. Dr. Friedemann Paul (WG Clinical Neuroimmunology, NCRC, ECRC), Dr. Ulrike Grieben (SPZ, Pediatrics)

Previous findings suggest that a healthy lifestyle can help reduce the risk of age-related diseases. In addition to smoking, alcohol consumption, weight and social interaction, special importance has been attributed to physical activity and nutrition. The direct impact of these influences on human cognition is, however, unclear, as are the underlying mechanisms.

This group investigates in various intervention studies (Project 1: Improving the brain through diet in elderly individuals; Project 2: Improving the brain through a combination of diet, exercise and cognitive stimulation in elderly individuals with existing Mild Cognitive Impairment MCI) the impact of exercise and healthy eating habits (including calorie restriction and omega-3 fatty acids) on the aging brain. To do this, neuropsychological tests, analysis of peripheral biomarkers in the blood, and imaging techniques such as structural and functional magnetic resonance imaging (MRI) will be used.

Study Director: Prof. Dr. Agnes Flöel (WG Cognitive Neurology, NCRC, CSB, Neurology CCM)

In this study, we investigate whether the regular taking of the extract of green tea (epigallocatechin gallate, EGCG) can slow the progression of the disease in patients with Alzheimer's disease. This is a multi-center A study, which is carried out at several centers., randomized The allocation to the treatment group is purely random., placebo-controlled In one study group the patients receive a so-called placebo. This is an imitation medication that looks like the study medicine but does not contain any active agent., double-blind Neither the patients nor the doctor know whether the patient is receiving the study medication or the placebo (or fotr studies without medication: to which study arm the patient has been allocated). study. Participation is open to male and female patients, from the age of 60, who have been diagnosed with Alzheimer's type dementia, who are in an early phase of the disease. The study medicine is taken twice a day as a capsule.

Study Director: Prof. Dr. Friedemann Paul (WG Clinical Neuroimmunology, NCRC, ECRC)

Previous findings suggest that exercise has a positive effect on vessels supplying the brain. Moreover, it has been shown that exercise can improve existing conditions of impaired glucose tolerance or diabetes mellitus, even in the absence of accompanying weight loss.

In this mono-center A study conducted at only one center., prospective In contrast to retrospective, a data collection and analysis relating to the future, i.e., a hypothesis has been established in advance of the investigation.  , single blind, randomized The allocation to the treatment group is purely random., placebo-controlled In one study group the patients receive a so-called placebo. This is an imitation medication that looks like the study medicine but does not contain any active agent. study, the effects of “Nordic Walking” on memory capacity and vascular functions in elderly people will be investigated. Our results will make it possible to develop specific exercise interventions for this group of elderly individuals, and possibly even pharmaceutical “exercise mimetics” (e.g. neurotrophic factors that can be injected).

Study Director: Prof. Dr. Agnes Flöel (WG Cognitive Neurology, NCRC, CSB, Neurology CCM)