Current studies

At present, approx. 40 clinical studies are being carried out at the NCRC (NeuroCure Clinical Research Center) on neurological and (neuro-)psychiatric diseases.

The studies listed here represent only a selection of the many diagnostic and therapeutic studies on MS offered at the NCRC. In addition to our own studies, we also take part in studies carried out by pharmaceutical companies (e.g. studies with Fingolimode (Novartis, FTY20-Study, Clinical Trial with Laquinimod (TEVA Pharma, MS-LAQ101-Study, Clinical Trial Register Number NCT00988052), with Copaxone (TEVA Pharma, GALA-Study, Clinical Trial Register Number NCT01067521), with Teri Teriflunomide (Sanofi-Aventis, TENERE, Clinical Trial Register Number NCT00883337) and for the treatment of osteoporosis in MS patients (Novartis, EXALT Study, Clinical Trial Register Number NCT01166178). 

Further studies, e.g. in muscular training through vibration or on the treatment of MS patients with vitamin D, are in preparation. 

Studies on Multiple Sclerosis (Selection):

SUPREMES study: Sunphenon (epigallocatechin-gallate) in progressive forms of multiple sclerosis:

Similar to the SUNIMS study, in the SUPREMES study the effectiveness of EGCG on various MRT parameters, disability progression and brain performance in MS patients is investigated. This is also a 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. study. Unlike the SUNIMS study, this study is oriented towards patients with primary or secondary chronic progressive MS. The running time is two and a half years per patient.

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

FLORIMS Study: Flupirtine as oral treatment of MS:

In this study we are investigating whether the daily intake of Flupirtine has a positive influence on various  MRT parameters in patients with relapsing-remitting MS. Other parameters for the damaging of nerve cells, the relapse rate and the progression of disability are also determined. Flupirtine is already approved as a medicine, has an analgesic effect and presumably has neuroprotective properties. 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. study. Participation is open to male and female patients who have been receiving MS treatment with Interferon-β1b (Betaferon®) for at least six months. The study medicine is taken as capsule twice a day for one year. The study medicine is generally tolerated well. Treatment with Interferon-β is continued during the study. In this study too, the patients are seen and examined regularly in the study outpatient clinic.

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

VISION Study: Visual restitution therapy after optic neuritis

In this study, we investigate whether the so-called visual restitution therapy (daily 30-minute domestic exercising of the sick eye with a PC-based program) improves vision after optic neuritis (inflammation of the optic nerve). Participation is open to all sufferers who have had acute optic neuritis in the last 6 months before inclusion or still have impaired vision from optic neuritis further in the past. This study is open to all forms of MS.

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

TMS-MS Study: Repetitive deep transcranial magnetic stimulation in fatigue and depressiveness in multiple sclerosis

In addition to fatigue, depressiveness is also a very frequent symptom of MS, to date it has not been possible to treat either of these symptoms well with medication. During the past few years, so-called transcranial magnetic stimulation (TMS) has increasingly been used successfully for the treatment of depression. We examine the effect of a new kind of TMS method upon depression and fatigue in patients with MS. This study is oriented towards MS patients with fatigue syndrome and/or depression and is open for all forms of MS.

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

EVIDIMS Study: Vitamin D in multiple sclerosis

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)

Flimmerbox Study: Investigation of critical flicker frequency as a functional parameter of retinal function in patients with multiple sclerosis

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)

REPABO Study: Patient-based measuring instruments in multiple sclerosis

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)

Clinically isolated syndrome and newly diagnosed multiple sclerosis: diagnostic, prognostic and therapy-response markers

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)

Studies on Neuromyelitis Optica (NMO):

NEMOS Study

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)

Studies on Susac's Syndrome:

Examination of suitable biomarkers in patients with Susac's syndrome and suitable control individuals" (Susac Study)

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)

Studies on Stroke (a selection):

PREDICT Study: Prediction of stroke-associated pneumonias

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)

BIAS Study: Beta-blockers in the treatment of acute ischemic stroke

BIAS is a 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. study on the toleration and efficacy of an early treatment of stroke patients with beta-blockers. It is intended to prevent both cardiac and infectious complications. You can find more detailed information here

Study Director: Prof. Dr. Wilhelm Haverkamp (Cardiology CVK) in cooperation with Prof. Dr. Andreas Meisel (WG Cerebrovascular Diseases, NCRC, CSB, Neurology CCM)

ARIMIS Study: Autoimmune phenomena after a stroke

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)

STRAWINSKI Study: An unfavorable outcome after a stroke is associated with nosocomial infections: PCTus-based antibacterial therapy in patients with severe ischemic stroke

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. study.

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

Pilot study for optic coherence tomography (OCT) in patients with ischemic Infarcts in the basin of the posterior cerebral artery

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)

Study: Use of a circle monitor system for diagnosing symptoms of neglect

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 (²paper and pencil² tests) are the main means of diagnosing neglect. The downside of these tasks is that they only test a small spatial area. In this study, new possibilities for diagnosing neglect will be tested on a circle monitor. This system consists of touch screens on which tasks can be presented and solved. We hope that testing with this system will increase diagnostic accuracy since it addresses a much larger search field.

The aim of this study is to detect even mild symptoms which are not picked up by traditional tests but can be relevant in complex daily life situations. This would make 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 modeling tasks from everyday life.

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

Contact person: Dr. Lena Ulm (WG Cerebrovascular Diseases, NCRC, Neurology CCM)

Participating cooperation partners: NeuroCure Cluster of Excellence (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).

 

Studies on Myasthenia Gravis (a selection):

The role of the thymus in myasthenia gravis

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)

MYASTHENIA Cohort: Myasthenia gravis: diagnostic, prognostic and therapy response markers

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)

Studies on chronic inflammatory demyelinating polyneuropathy CIPD (a selection):

Humoral mechanisms of CIDP

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare, progressive or relapsing disease of peripheral nerves, which is characterized by symmetrical, sensorimotor symptoms.

Patients affected normally also benefit from a plasmapheresis (a plasma-purifying procedure) or the administering of intravenous immunoglobulins (IVIG). In this study, we are searching for serologic (affecting Antigen-Antibody-Reactions) markers that can be made responsible for part of the nerve damage and/or can prognosticate a therapy response with IVIG. For this, blood samples from affected patients are examined and analyzed together with clinical data of the patients.

Study Director: Dr. Hendrik Harms (WG Cerebrovascular Diseases, NCRC, Neurology CCM)

Mechanisms of Immune Regulation by IVIG

This study investigates the effect of immunoglobulins (antibodies) on cellular components of the immune system. We are above all interested to what extent the administering of immunoglobulins changes the function of certain immune cells.

Study Director: Dr. Hendrik Harms (WG Cerebrovascular Diseases, NCRC, Neurology CCM)

CIDP Cohort: Chronically inflammatory demyelinating polyneuropathy: diagnostic, prognostic and therapy response markers

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. Hendrik Harms (WG Cerebrovascular Diseases, NCRC, Neurology CCM)

Studies on Developmental Disorders of the Nervous System (e.g. Epilepsy) (a selection):

The Causes of Febrile Seizure

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)

Genetic Causes of Severe Epilepsy in Early Childhood

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. M. Schülke-Gerstenfeld (WG Developmental Disorders of the Nervous System, NCRC, Pediatrics CVK)

Genetic Causes of Arthrogryposis Multiplex Congenita

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)

Development of Software for the Evaluation of Gene Variants and Pathogenic Mutations in Humans

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. M. Schülke-Gerstenfeld (WG Developmental Disorders of the Nervous System, NCRC, Pediatrics CVK)

Studies on Duchenne Muscular Dystrophy:

SUNIMUD Study: Sunphenon EGCg (Epigallocatechin Gallate) in Duchenne-Type Muscular Dystrophy

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. 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)

Studies on Alzheimer's Disease (a selection):

SUNAK Study: Sunphenon EGCg (Epigallocatechin Gallate) in the Early Stage of Alzheimer's Disease

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. 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)