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Clinical Trial at the Medical University of Graz


In 2016 a clinical trial was performed at the Medical University of Graz. The results of the trial showed that the Tremipen® is able to quantify tremor and its parameters tremor amplitude, tremor frequency and tremor energy.

 

P. Schwingenschuh¹, M. Kögl-Wallner¹, T. Zajki-Zechmeister², N. Homayoon¹, K. Kalsberger¹, L. Zajki-Zechmeister², R. Schmidt¹

¹ Universitätsklinik für Neurologie, Medical University of Graz
² Tremitas GmbH

 

Summary of the Trail:

In 2016, a clinical trial was implemented at the Medical University of Graz in Austria. 30 patients, 14 being diagnosed with Parkinson’s Disease and 16 diagnosed with Essential Tremor, where recruited to test the Tremitas Technology:

 

Introduction:

Tremor is the most common human movement disorder and it would be preferable to be able to quantify tremor intensities during everyday clinical practice and for scientific issues. The aim of this study was to examine the benefits of the tremor pen (Tremitas System) for the following issues: (1) Quantification of tremor intensity, (2) Differentiation between Parkinson’s Disease (PD) and Essential Tremor (ET) (3) Examine therapeutic effects of medications.

 

Methods:

For these issues, 14 patients with PD and 16 patients with ET were examined clinically (TETRAS-Scale and MDS-UPDRS) and with the tremor pen, after stopping tremor relevant medications for at least 12 hours (Baseline). A second examination was done one hour after a medication intake (ON) (100% morning dose of the individual anti-tremor medication for ET and 150% of the L-Dopa-Equivalence morning dose for PD; served as soluble form of Levodopa/Benserazid). The main value for ET was the tremor amplitude of the tremor during a holding position (right and left combined) and for PD the amplitude of the resting tremor for the more affected side. “Total Power” and “Power of Main Peak” were the surrogate markers for the tremor amplitude. For a comparison with clinical scales, the log of the raw data was used. The data analysis was automatically done by the Tremitas Software.

 

Results:

(ad 1) Our study showed that it is possible to quantify tremor intensity for PD and ET. Within the ET group, we found good correlations between the tremor intensity measured by the tremor pen and the corresponding clinical subitem of the TETRAS-Scale (Performance, 4a) (r=0.74). Within the PD group, good correlations between the tremor intensity measured by the tremor pen and the corresponding clinical subitems of MDS-UPDRS III (3.17 and 3.18) (r= 0.70) were found as well. (ad 2) It was not possible to differentiate PD and ET based on tremor amplitude and tremor frequency. (ad 3) The comparison between Baseline and ON showed a significant improvement of the tremor amplitude for PD (p=0.027), but not for ET.

 

Conclusion:

The tremor pen (Tremitas-System) can quantify the tremor of patients having PD and ET. Changes of tremor intensity, as a consequence of therapeutic effects, were well captured for PD.

 

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