Brain-Oscillation-Synchronized Stimulation to Enhance Motor Recovery in Early Subacute Stroke

Inclusion Criteria:

Subjects meeting all of the following criteria will be considered for admission to the trial:

1. Age ≥ 18 years at the time of signing the informed consent.

2. Cerebral ischemia identified by brain imaging (cerebral MRI or CT) occurred 1-14days ago.

3. Subject understands and voluntarily signs an informed consent document prior to anystudy related assessments/procedures.

4. Stroke has resulted in a new arm-/hand motor deficit with ≤ 50 points in the FMA-UE.

5. Presence of motor evoked potentials (MEPs) in the paretic hand. MEPs has to beobtained in the resting muscle o If no MEPs can be obtained, MEP search procedure can be repeated later up to 14days after stroke onset.

6. ● μ-oscillation (8-12 Hz) is recordable by EEG in the ipsilesional sensorimotorcortex with a sufficient signal-to-noise ratio of at least 3 dB

7. ● Subject is able to adhere to the study visit schedule and other protocolrequirements.

Exclusion Criteria:

Subjects presenting with any of the following criteria will not be included in the trial:

1. Hemorrhagic stroke (this refers to primary intracerebral hemorrhage only;hemorrhagic transformation of ischemic infarcts is not an exclusion criterion)

2. Estimated life expectancy < 12 months

3. Presence of intracranial ferromagnetic metal (extracranial stents ≥10 cm away fromthe TMS coil are acceptable) in accordance with current safety guidelines [18]

4. Intraocular metal, cochlear implants

5. If TMS might interact with sensors of active implants (e.g., intra-cardiacdefibrillators).

6. If a cranial bone gap affects currents induced by TMS (such as after craniotomy).

7. History of seizures or epilepsy.

8. Treatment intervention can't be started within 14 days after onset of stroke.

9. Women during pregnancy and lactation.

10. Participation in other studies if they are MDR or AMG studies or there is otherwisea high risk of insurance law issues intervening between two studies. In case ofuncertainty, competing insurances must be contacted prior to participation

11. persistent addiction disorder (except for nicotine dependence)

12. CNS malignoma

13. If there is any concern by the investigator regarding the safe participation of thesubject in the study or for any other reason the investigator considers the subjectinappropriate for participation in the study.

14. The ability to consent for patients who are unable to speak will be assessed on thebasis of the NIHS-Score by an independent physician (details see chapter 21 andappendix).