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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Tuebingen

About this trial

We will investigate the therapeutic efficacy of EEG-synchronized noninvasive repetitive transcranial magnetic stimulation (rTMS) in the early subacute phase after ischemic stroke to improve upper limb motor rehabilitation. We hypothesize that synchronization of rTMS with the phase of the ongoing sensorimotor oscillation indicating high corticospinal excitability leads to significantly stronger improvement of paretic upper limb motor function than the same rTMS protocol non-synchronized to the ongoing sensorimotor oscillation or sham stimulation.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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 [18]

Intraocular metal, cochlear implants

Trial design

Treatments tested in this trial

  • Bossdevice

Treatment groups

144 Participants
are divided into 3 treatment groups

Sponsors and collaborators