Brain-Oscillation-Synchronized Stimulation to Enhance Motor Recovery in Early Subacute Stroke (Boss-Stroke)
Ischemic Stroke, Acute
About this trial
This is an interventional treatment trial for Ischemic Stroke, Acute
Eligibility Criteria
Inclusion Criteria: Subjects meeting all of the following criteria will be considered for admission to the trial: Age ≥ 18 years at the time of signing the informed consent. Cerebral ischemia identified by brain imaging (cerebral MRI or CT) occurred 1-14 days ago. Subject understands and voluntarily signs an informed consent document prior to any study related assessments/procedures. Stroke has resulted in a new arm-/hand motor deficit with ≤ 50 points in the FMA-UE. Presence of motor evoked potentials (MEPs) in the paretic hand. MEPs has to be obtained in the resting muscle o If no MEPs can be obtained, MEP search procedure can be repeated later up to 14 days after stroke onset. μ-oscillation (8-12 Hz) is recordable by EEG in the ipsilesional sensorimotor cortex with a sufficient signal-to-noise ratio of at least 3 dB Subject is able to adhere to the study visit schedule and other protocol requirements. Exclusion Criteria: Subjects presenting with any of the following criteria will not be included in the trial: Hemorrhagic stroke (this refers to primary intracerebral hemorrhage only; hemorrhagic transformation of ischemic infarcts is not an exclusion criterion) Estimated life expectancy < 12 months Presence of intracranial ferromagnetic metal (extracranial stents ≥10 cm away from the TMS coil are acceptable) in accordance with current safety guidelines Intraocular metal, cochlear implants If TMS might interact with sensors of active implants (e.g., intra-cardiac defibrillators). If a cranial bone gap affects currents induced by TMS (such as after craniotomy). History of seizures or epilepsy. Treatment intervention can't be started within 14 days after onset of stroke. Women during pregnancy and lactation. Participation in other clinical trials or observation period of competing trials, if this participation affects the primary endpoint of the boss-stroke study. If the endpoint is not affected, participation is allowed. persistent addiction disorder (except for nicotine dependence) CNS malignoma If there is any concern by the investigator regarding the safe participation of the subject in the study or for any other reason the investigator considers the subject inappropriate for participation in the study. The ability to consent for patients who are unable to speak will be assessed on the basis of the NIHS-Score by an independent physician
Sites / Locations
- Universitätsklinikum Frankfurt, Zentrum der Neurologie und Neurochirurgie
- Universitätsmedizin Greifswald, Klinik und Poliklinik für Neurologie
- Uniklinik Köln, Klinik und Poliklinik für Neurologie
- Universitätsklinikum Leipzig, Klinik und Poliklinik für Neurologie
- Universitätsmedizin Mainz, Klinik und Poliklinik für Neurologie
- Universitätsklinikum Münster, Klinik für Allgemeine Neurologie
- Universitätsklinikum Tübingen, Klinik für NeurologieRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
No Intervention
No Intervention
Personalized stimulation
Non-personalized stimulation
Sham stimulation
Each 100 Hz triplet is triggered when a real-time analyzed EEG-defined state of high corticospinal excitability is detected (i.e., the negative peak of the ongoing sensorimotor ~10 Hz μ-oscillation).
The identical rTMS protocol as in Arm 1, but 100 Hz triplets are not synchronized to the ongoing sensorimotor μ-oscillation.
The same protocol as in arm 1 synchronized to the EEG-defined high excitability state, but with ineffective rTMS, using the sham side of an active/placebo TMS coil designed for double-blind clinical trials. Conditions/arm 2 and 3 are control conditions. Arm 2 controls for the specific effect of Condition/arm 1 to synchronize stimulation to the ongoing μ-oscillation. Arm 3 tests if auditory or somatosensory inputs (which are identical in the real and sham stimulation conditions) synchronized with the ongoing μ-oscillation are relevant for the effects of Arm 1.