Brain‐oscillation-synchronized stimulation to enhance motor recovery in early subacute stroke: a randomized controlled double‐blind three‐ arm parallel‐group exploratory trial comparing personalized, non‐ personalized and sham repetitive transcranial magnetic stimulation (Acronym: BOSS-STROKE)
Abstract Background Stroke is a major cause of death and the most frequent cause of permanent disability in western countries. Repetitive transcranial brain stimulation (rTMS) has been used to enhance neuronal plasticity after stroke, yet with only moderate effect sizes. Here we will apply a highly...
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| Format: | Article |
| Language: | English |
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BMC
2023-05-01
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| Series: | BMC Neurology |
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| Online Access: | https://doi.org/10.1186/s12883-023-03235-1 |
| _version_ | 1827633833884778496 |
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| author | Anne Lieb Brigitte Zrenner Christoph Zrenner Gábor Kozák Peter Martus Christian Grefkes Ulf Ziemann |
| author_facet | Anne Lieb Brigitte Zrenner Christoph Zrenner Gábor Kozák Peter Martus Christian Grefkes Ulf Ziemann |
| author_sort | Anne Lieb |
| collection | DOAJ |
| description | Abstract Background Stroke is a major cause of death and the most frequent cause of permanent disability in western countries. Repetitive transcranial brain stimulation (rTMS) has been used to enhance neuronal plasticity after stroke, yet with only moderate effect sizes. Here we will apply a highly innovative technology that synchronizes rTMS to specific brain states identified by real-time analysis of electroencephalography. Methods One hundred forty-four patients with early subacute ischemic motor stroke will be included in a multicenter 3-arm parallel, randomized, double-blind, standard rTMS and sham rTMS-controlled exploratory trial in Germany. In the experimental condition, rTMS will be synchronized to the trough of the sensorimotor µ-oscillation, a high-excitability state, over ipsilesional motor cortex. In the standard rTMS control condition the identical protocol will be applied, but non-synchronized to the ongoing µ-oscillation. In the sham condition, the same µ-oscillation-synchronized protocol as in experimental condition will be applied, but with ineffective rTMS, using the sham side of an active/placebo TMS coil. The treatment will be performed over five consecutive work days (1,200 pulses per day, 6,000 pulses total). The primary endpoint will be motor performance after the last treatment session as measured by the Fugl-Meyer Assessment Upper Extremity. Discussion This study investigates, for the first time, the therapeutic efficacy of personalized, brain-state-dependent rTMS. We hypothesize that synchronization of rTMS with a high-excitability state will lead to significantly stronger improvement of paretic upper extremity motor function than standard or sham rTMS. Positive results may catalyze a paradigm-shift towards personalized brain-state-dependent stimulation therapies. Trial registration This study was registered at ClinicalTrials.gov (NCT05600374) on 10–21-2022. |
| first_indexed | 2024-03-09T15:05:00Z |
| format | Article |
| id | doaj.art-7de047fe64d345c893a9a261df0fa621 |
| institution | Directory Open Access Journal |
| issn | 1471-2377 |
| language | English |
| last_indexed | 2024-03-09T15:05:00Z |
| publishDate | 2023-05-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Neurology |
| spelling | doaj.art-7de047fe64d345c893a9a261df0fa6212023-11-26T13:42:20ZengBMCBMC Neurology1471-23772023-05-0123111710.1186/s12883-023-03235-1Brain‐oscillation-synchronized stimulation to enhance motor recovery in early subacute stroke: a randomized controlled double‐blind three‐ arm parallel‐group exploratory trial comparing personalized, non‐ personalized and sham repetitive transcranial magnetic stimulation (Acronym: BOSS-STROKE)Anne Lieb0Brigitte Zrenner1Christoph Zrenner2Gábor Kozák3Peter Martus4Christian Grefkes5Ulf Ziemann6Department of Neurology and Stroke, and Hertie-Institute for Clinical Brain Research, University of TübingenTemerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental HealthDepartment of Neurology and Stroke, and Hertie-Institute for Clinical Brain Research, University of TübingenDepartment of Neurology and Stroke, and Hertie-Institute for Clinical Brain Research, University of TübingenInstitute for Clinical Epidemiology and Applied Statistics, University of TübingenDepartment of Neurology, Goethe University FrankfurtDepartment of Neurology and Stroke, and Hertie-Institute for Clinical Brain Research, University of TübingenAbstract Background Stroke is a major cause of death and the most frequent cause of permanent disability in western countries. Repetitive transcranial brain stimulation (rTMS) has been used to enhance neuronal plasticity after stroke, yet with only moderate effect sizes. Here we will apply a highly innovative technology that synchronizes rTMS to specific brain states identified by real-time analysis of electroencephalography. Methods One hundred forty-four patients with early subacute ischemic motor stroke will be included in a multicenter 3-arm parallel, randomized, double-blind, standard rTMS and sham rTMS-controlled exploratory trial in Germany. In the experimental condition, rTMS will be synchronized to the trough of the sensorimotor µ-oscillation, a high-excitability state, over ipsilesional motor cortex. In the standard rTMS control condition the identical protocol will be applied, but non-synchronized to the ongoing µ-oscillation. In the sham condition, the same µ-oscillation-synchronized protocol as in experimental condition will be applied, but with ineffective rTMS, using the sham side of an active/placebo TMS coil. The treatment will be performed over five consecutive work days (1,200 pulses per day, 6,000 pulses total). The primary endpoint will be motor performance after the last treatment session as measured by the Fugl-Meyer Assessment Upper Extremity. Discussion This study investigates, for the first time, the therapeutic efficacy of personalized, brain-state-dependent rTMS. We hypothesize that synchronization of rTMS with a high-excitability state will lead to significantly stronger improvement of paretic upper extremity motor function than standard or sham rTMS. Positive results may catalyze a paradigm-shift towards personalized brain-state-dependent stimulation therapies. Trial registration This study was registered at ClinicalTrials.gov (NCT05600374) on 10–21-2022.https://doi.org/10.1186/s12883-023-03235-1Transcranial magnetic stimulation (TMS)Brain oscillationBrain-state-dependent stimulationSensorimotor µ-oscillationTMS-EEGPersonalized treatment |
| spellingShingle | Anne Lieb Brigitte Zrenner Christoph Zrenner Gábor Kozák Peter Martus Christian Grefkes Ulf Ziemann Brain‐oscillation-synchronized stimulation to enhance motor recovery in early subacute stroke: a randomized controlled double‐blind three‐ arm parallel‐group exploratory trial comparing personalized, non‐ personalized and sham repetitive transcranial magnetic stimulation (Acronym: BOSS-STROKE) BMC Neurology Transcranial magnetic stimulation (TMS) Brain oscillation Brain-state-dependent stimulation Sensorimotor µ-oscillation TMS-EEG Personalized treatment |
| title | Brain‐oscillation-synchronized stimulation to enhance motor recovery in early subacute stroke: a randomized controlled double‐blind three‐ arm parallel‐group exploratory trial comparing personalized, non‐ personalized and sham repetitive transcranial magnetic stimulation (Acronym: BOSS-STROKE) |
| title_full | Brain‐oscillation-synchronized stimulation to enhance motor recovery in early subacute stroke: a randomized controlled double‐blind three‐ arm parallel‐group exploratory trial comparing personalized, non‐ personalized and sham repetitive transcranial magnetic stimulation (Acronym: BOSS-STROKE) |
| title_fullStr | Brain‐oscillation-synchronized stimulation to enhance motor recovery in early subacute stroke: a randomized controlled double‐blind three‐ arm parallel‐group exploratory trial comparing personalized, non‐ personalized and sham repetitive transcranial magnetic stimulation (Acronym: BOSS-STROKE) |
| title_full_unstemmed | Brain‐oscillation-synchronized stimulation to enhance motor recovery in early subacute stroke: a randomized controlled double‐blind three‐ arm parallel‐group exploratory trial comparing personalized, non‐ personalized and sham repetitive transcranial magnetic stimulation (Acronym: BOSS-STROKE) |
| title_short | Brain‐oscillation-synchronized stimulation to enhance motor recovery in early subacute stroke: a randomized controlled double‐blind three‐ arm parallel‐group exploratory trial comparing personalized, non‐ personalized and sham repetitive transcranial magnetic stimulation (Acronym: BOSS-STROKE) |
| title_sort | brain oscillation synchronized stimulation to enhance motor recovery in early subacute stroke a randomized controlled double blind three arm parallel group exploratory trial comparing personalized non personalized and sham repetitive transcranial magnetic stimulation acronym boss stroke |
| topic | Transcranial magnetic stimulation (TMS) Brain oscillation Brain-state-dependent stimulation Sensorimotor µ-oscillation TMS-EEG Personalized treatment |
| url | https://doi.org/10.1186/s12883-023-03235-1 |
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