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Navigated Repetitive Transcranial Magnetic Stimula ...
Navigated Repetitive Transcranial Magnetic Stimulation Improves the Outcome of Postsurgical Ischemia-related Paresis in Glioma Patients – A Randomized, Sham-controlled Double-blinded Trial
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Video Transcription
Dear ladies and gentlemen, dear chairman, thank you for giving me the opportunity to present the results of our randomized sham controlled double-blinded trial on navigated repetitive transcranial magnetic stimulation and how it improves the outcome of post-surgical ischemia-related paresis in glioma patients. Navigated repetitive transcranial magnetic stimulation therapy studies have already been performed in stroke patients and in these patients an Artemis therapy has shown to be very effective in most of the trials regarding the stimulation protocols especially low frequency stimulation of the non-damaged hemisphere has shown to be supporting the neuro-rehabilitation of stroke patients with the aim of reducing the pathological transcalosal inhibition. So for the present trial the objective was to examine the effect of post-operative an Artemis therapy of the unaffected hemisphere in glioma patients suffering from acute surgery-related paresis of the upper extremity due to subcortical ischemia. We therefore performed a randomized sham-controlled double-blinded trial in patients suffering from acute surgery-related paresis of the upper extremity after glioma resection. The randomization protocol was 2 to 1 and patients were randomized to receive either low frequency an Artemis stimulation with a stimulation frequency of one hertz for 15 minutes or sham stimulation with a special sham protocol. Both an Artemis stimulation or the sham stimulation were performed directly before physical therapy of 30 minutes and the whole protocol was performed for seven consecutive days. Primary and secondary outcome measures were assessed on day one, day seven and at three month follow-up and the primary endpoint of the trial was the change in Fugl-Meyer assessments at follow-up. For secondary outcome measures we used the National Institutes of Health Stroke Scale, the Jepson and Taylor Hand Function Tests, the 9-hole PEG test and the Konofsky Performance Scale. This is the workflow of the trial. The trial started directly after surgery. We performed a standard post-operative MRI scan and assessed patients for eligibility in case of a new post-operative deficit of the upper extremity and subcortical ischemia in the post-operative MRI scan. We performed a post-operative NTMS motor mapping in order to differentiate between patients in which we were able to elicit motor evoked potentials by NTMS mapping or not and in case of motor evoked potentials patients underwent randomization after written informed consent. For an RTMS group we stimulated over the contralesional motor hotspot with a stimulation frequency of one hertz and a stimulation intensity of 110 percent of the resting motor threshold as measured by post-operative NTMS motor mapping. We stimulated for 15 minutes leading to 900 pulses and in the sham group we also stimulated with a special sham protocol for 15 minutes over the contralesional motor hotspot. Stimulations and sham stimulations including 30 minutes of physical therapy in both groups were performed on seven consecutive days directly after surgery and outcome measures were assessed as already mentioned on day one, day seven and three months follow-up. In total we randomized 22 patients, 16 of them were allocated to the NRTMS stimulation group and six of them were allocated to the sham stimulation group. Apart from the tumor hemisphere the baseline characteristics were well balanced between the two groups and finally we had a complete analysis of 14 patients in the NRTMS group and five patients in the sham group. Most importantly no patient suffered from adverse events during or after the treatment period. So regarding the primary endpoints of the trial the Fugl-Meier assessment here you can see the results of the NRTMS stimulation group in blue and the sham stimulation group in red on day one, day seven and follow-up and the change in Fugl-Meier assessments between day one and follow-up was statistically significant and regarding a minimal clinically important difference of an improvement of 10 points on the Fugl-Meier assessments we found a number needed to treat of 2.19. For secondary outcome measures the results of the National Institutes of Health Stroke Scale also differed significantly between the two groups. Regarding the stroke severity score we calculated a number needed to treat of 1.75 and for the NIHSS subscore the motor arm score we also found different results with statistical significance and the number needed to treat for an improvement on the motor arm score was 1.89. So to conclude this is the first study to examine the effect of NRTMS stimulation therapy in patients suffering from acute functional deficits after glioma resection. Patients suffering from acute surgery-related paresis of the upper extremity due to subcortical ischemia significantly benefit from immediate acute phase NRTMS stimulation of the contralesional hemisphere combined with physical therapy. Thank you for your attention. Thank you.
Video Summary
The video summarizes the results of a randomized trial on navigated repetitive transcranial magnetic stimulation (NRTMS) and its impact on post-surgical ischemia-related paresis in glioma patients. NRTMS therapy has previously proven effective in stroke patients, specifically when low-frequency stimulation of the non-damaged hemisphere is used to reduce transcalosal inhibition. In this trial, the objective was to assess the effect of post-operative NRTMS therapy on glioma patients with acute surgery-related paresis of the upper extremity. The trial involved randomized sham-controlled double-blinded groups receiving either NRTMS stimulation or sham stimulation before physical therapy for seven consecutive days. The primary endpoint was the change in Fugl-Meyer assessments, and secondary outcome measures were assessed. The trial showed statistically significant improvements in motor function for patients who received NRTMS stimulation combined with physical therapy. No adverse events were reported.
Asset Subtitle
Sebastian Ille, MD
Keywords
navigated repetitive transcranial magnetic stimulation
post-surgical ischemia-related paresis
glioma patients
NRTMS therapy
Fugl-Meyer assessments
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