Brain-Oscillation-Synchronized Stimulation to Enhance Motor Recovery in Early Subacute Stroke (NCT05600374) | Clinical Trial Compass
RecruitingNot Applicable
Brain-Oscillation-Synchronized Stimulation to Enhance Motor Recovery in Early Subacute Stroke
Germany144 participantsStarted 2023-02-06
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. ● 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Motor performance after the intervention
Timeframe: After the last treatment session (5 days after first treatment)
. ● Subject is able to adhere to the study visit schedule and other protocol requirements.
Exclusion criteria
. 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
. 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.