Trial document





This trial has been registered retrospectively.
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  DRKS00008732

Trial Description

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Title

Neuronal plasticity of network topography in parkinson disease through LSVT-BIG therapy

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Background: In the progression of their disease, the idiopathic parkinson-syndrome (IPS) increasingly impairs patients in their quality of life (Hackney et al. 2009). This can be seen in increasing motoric dysfunctions but also in non-motor symptoms such as cognitive impairments, depression, pain or sleep disorders (Barone et al. 2009). Nowadays, there are plenty of drug therapeutic options available. But especially the complementary therapeutic options received a high status in the treatment of parkinson patients over the last couple of years (Carne et al. 2005, Trend et al. 2002, Ellis et al. 2008, Wade et al. 2003). Especially in the physiotherapeutic section there are several different therapeutical approaches - but until now there exist no guidelines about the implementation of the physiotherapeutic treatment in Germany, even although there are are international recommendations (Keus et al. 2007, European physiotherapy guideline for parkinson´s disease). LSVT-BIG-therapy was designed as an structured therapeutical treatment approach. Its based on a high number of repetitions, big amplitude movements and an increasing complexity of the movements in the course of the physiotherapy. Aim is to improve the perception of the patients movements and to recalibrate the dysfunctional scale of movement-amplitude. Previous studies have shown, that LSVT-BIG therapy leads to an improvement of the motoric functions
in parkinson disease. The Improvement was most significant in the UPDRS III score after 16 Weeks, comparing to other trainings like nordic-walking or self structured workouts (Ebersbach et al. 2010). Improvements were also achieved in short protocols, even though the objective (UPDRS III) and subjective improvements were not that significant (Ebersbach et al. 2015). The few studies until now have all taken the motoric improvements as primary outcome parameters. They did not test in how far the NMS (non motoric symptoms) (like pain, sleep disorders, mood) also improve by an intensive physiotherapeutic treatment. Furthermore it is unknown which areas of the motoric network improve most or change in terms of neuronal plasticity through intensive physiotherapeutic training. Clinical studies have already shown the effect of movement on the neuronal plasticity in the IPS. They describe neuroplasticity as a progress where the brain codes experiences, learns new manners and safes them by changing already existing synapses or adding new ones in the brain-network. There are more and more hints in the literature which show that exercise based as well as aerobic based training leads to an enhanced connection in the motoric network with changes in the dopaminergic and glutaminergic transmission. They also describe an enhanced structural synaptic modification (Petzinger et al. 2013). The changed blood flow and the generally improved brain capacity can upgrade the neuronal plasticity. That ist the basis for a facilitation of motor skills, of the cognitive function and a general better behavioral performance. Changes of the morphometric brain parameters can be reached by constant training (Sehm et al. 2014). Neuronal plasticity was for example achieved by exercising a balance test over six weeks: there were found changes in the substantia grisea, in the right anterior precuneus, in the left inferior parietal cortex, in the left ventral premotoric cortex, in the bilateral anterior cingulum and in the left medial temporal gyrus. Changes in the network are so far only reported in animal models. For example in a parkinson lesion experiment with rats where they showed that after intensive aerobic training there was a normalization of lesion induced alteration in resting-state functional connectivity with reintegration of the dorsolateral striatum in the motoric network. Furthermore the ventrolateral striatum was integrated as a new network-hub and they detected a higher functional connectivity between the motor cortex, the motoric thalamus core, the basal ganglia an the cerebellum (Wang et al. 2014). The motoric control integrates several cortical and subcortical structures. Most important are the connections between the basal ganglia and the cortex. They are involved in automatic and cognitive aspects of the motoric control. The loss of dopaminergic neurons in the dorsal area of the basal ganglia leads in IPS to an impairment of the automated movements. They involve the connection to stimulus based habitual learning or excessive recruitment of cognitive components of the motoric control and network involved in rewarded based learning.

HYPOTHESIS: LSVT-BIG-therapy improves motoric as well as non-motoric symptoms just because of a higher attention within the time-consuming physiotherapy. So there is no difference in the primary outcome-parameter NMS-Score between the LSVT-BIG-therapy group and the conventional intensive physiotherapy group. Both in LSVT-BIG and in intensive conventional physiotherapy there can be seen a higher functional connectivity in comparison pre vs. post therapy in the motoric network. This correlates with improvements in the primary and secondary outcome-parameters.
RESEARCH OBJECTIVE:
1.) report changes of the non-motoric symptoms through LSVT-BIG-Therapy in comparison to the intensive conventional physiotherapy.
2.) display through rs-fMRI the changes of the motoric network through intensive motor-training

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Organizational Data

  •   DRKS00008732
  •   2015/11/09
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  •   yes
  •   Approved
  •   15-200, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   G20 -  Parkinson disease
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Interventions/Observational Groups

  •   20 patients receive LSVT-BIG therapy for 4 weeks (4x 60 min per week). Before and after the 4 weeks of therapy, half of them gets an rs-fMRI. All of them need to do a gangway-test ( three times with and three times without shoes), the chair-rising-test (three times), UPDRS III, NMS, PDQ-39, AES, BDI-2, MMST and the Panda.
  •   20 patients receive intensive physiotherapy for 4 weeks (4x 60 min per week). Before and after the 4 weeks of therapy, half of them gets an rs-fMRI. All of them need to do a gangway-test ( three times with and three times without shoes), the chair-rising-test (three times), UPDRS III, NMS, PDQ-39, AES, BDI-2, MMST and the Panda.
  •   20 patients receive normal physiotherapy for 8 weeks (2x 30 min per week). Before and after the 4 weeks of therapy, half of them gets an rs-fMRI. All of them need to do a gangway-test ( three times with and three times without shoes), the chair-rising-test (three times), UPDRS III, NMS, PDQ-39, AES, BDI-2, MMST and the Panda.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Improvement of non-motor-symptoms before and after the physiotherapy. Evaluation through the NMS-Score in the week before and after the therapy. Socre is taken in the week before and after the physiotherapy.

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Secondary Outcome

- Motoric functions (UPDRS III), video hast to be recorded baseline up to 7 days before the physiotherapy starts and follow-up within the 7 days after the end of physiotherapy. Evaluation by two persons.
- Psychometric functions (BDI-2, AES, PANDA and MMST). Questionnaires have to be answered baseline up to 7 days before the physiotherapy starts and follow-up within the 7 days after the end of physiotherapy.
-PDQ-39 evaluates quality of life. Questionnaire has to be answered baseline up to 7 days before the physiotherapy starts and follow-up within the 7 days after the end of physiotherapy.
- ReHo/Fc rs-fMRI with the focus on the motoric network activity and core theme on the premotoric cortex, SMA, primary sensomotoric cortex, putamen and cerebellum, rs-fMRI has to be done in the week before and after the physiotherapy at the same time.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/09/15
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   25   Years
  •   80   Years
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Additional Inclusion Criteria

Patients (Gender masculin or feminin) with the clinical diagnosis of an idiopathic parkinson syndrome. Age between 25 and 80 years. Good german language skills. Patients need to be capable to consent and have to sign a consent.

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Exclusion Criteria

Patients, who suffer under another disease that affects their cognition (for example vascular disease, Tumor). Patients with strong depression (BDI over 29 points) and/or dementia (Panda < 14 points). If there is a reason to expect incompliance concerning the participation in the study. Heavy motoric complications (unexpectaple On-Offs, heavy dyskinesis, heavy Off-Dystonie). Reduced physical constitution with chest pain and breathlessness at soft physical exercise (COPD, cardiac insufficiency). Deep brain stimulation, pump therapy. Unknown loss of body weight (>20 %) in the last 6 months. Pulmonary embolism, myocardial infarct, endocarditis in the last 3 months. Haemodynamic relevant stenosis of aortic valve and/or mitralic valve.

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Addresses

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    • Uniklinik Köln
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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    • Neurologie Uniklinik Köln
    • Mr.  PD Dr.  Carsten  Eggers 
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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    • Neurologie Uniklinik Köln
    • Mr.  cand. med. Fabian  Schaible 
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik Köln
    • PD Dr. Carsten  Eggers 
    • Kerbender Straße 62
    • 50937  Köln
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.