Last updated: November 20, 2023
Sponsor: University Hospital Tuebingen
Overall Status: Active - Recruiting
Phase
N/A
Condition
Thrombosis
Stroke
Cardiac Ischemia
Treatment
Bossdevice
Clinical Study ID
NCT05600374
BOSS-STROKE
01KG2125
CIV-22-01-038788
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Subjects meeting all of the following criteria will be considered for admission to thetrial:
- Age ≥ 18 years at the time of signing the informed consent.
- Cerebral ischemia identified by brain imaging (cerebral MRI or CT) occurred 1-14 daysago.
- Subject understands and voluntarily signs an informed consent document prior to anystudy 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 beobtained in the resting muscle o If no MEPs can be obtained, MEP search procedure can be repeated later up to 14 daysafter stroke onset.
- ● μ-oscillation (8-12 Hz) is recordable by EEG in the ipsilesional sensorimotor cortexwith a sufficient signal-to-noise ratio of at least 3 dB
- ● Subject is able to adhere to the study visit schedule and other protocolrequirements.
Exclusion
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; hemorrhagictransformation of ischemic infarcts is not an exclusion criterion)
- Estimated life expectancy < 12 months
- Presence of intracranial ferromagnetic metal (extracranial stents ≥10 cm away from theTMS coil are acceptable) in accordance with current safety guidelines [18]
- Intraocular metal, cochlear implants
- If TMS might interact with sensors of active implants (e.g., intra-cardiacdefibrillators).
- 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 studies if they are MDR or AMG studies or there is otherwise ahigh risk of insurance law issues intervening between two studies. In case ofuncertainty, competing insurances must be contacted prior to participation
- persistent addiction disorder (except for nicotine dependence)
- CNS malignoma
- 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.
- 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).
Study Design
Total Participants: 144
Treatment Group(s): 1
Primary Treatment: Bossdevice
Phase:
Study Start date:
February 06, 2023
Estimated Completion Date:
February 28, 2026
Study Description
Connect with a study center
Universitätsklinikum Frankfurt, Zentrum der Neurologie und Neurochirurgie
Frankfurt a.M., 60528
GermanySite Not Available
Universitätsmedizin Greifswald, Klinik und Poliklinik für Neurologie
Greifswald, 17475
GermanySite Not Available
Uniklinik Köln, Klinik und Poliklinik für Neurologie
Köln, 50937
GermanySite Not Available
Universitätsklinikum Leipzig, Klinik und Poliklinik für Neurologie
Leipzig, 04103
GermanySite Not Available
Universitätsmedizin Mainz, Klinik und Poliklinik für Neurologie
Mainz, 55131
GermanySite Not Available
Universitätsklinikum Münster, Klinik für Allgemeine Neurologie
Münster, 48149
GermanySite Not Available
Universitätsklinikum Tübingen, Klinik für Neurologie
Tübingen, 72076
GermanyActive - Recruiting
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