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New treatment option for Ischemic Stroke, Acute
Official title Brain-Oscillation-Synchronized Stimulation to Enhance Motor Recovery in Early Subacute Stroke
ClinicalTrials.gov ID: NCT05600374
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people 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.
You likely can't join if
- people 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...
- 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...
- Intraocular metal, cochlear implants
- If TMS might interact with sensors of active implants (e.g., intra-cardiac defibrillators).
See the full eligibility criteria
- people 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.
- people 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 [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.
- Women during pregnancy and lactation.
- Participation in other studies if they are MDR or AMG studies or there is otherwise a high risk of insurance law issues intervening between two studies. In case of uncertainty, competing insurances must be contacted...
- 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 (details see chapter 21 and appendix).
The study team makes the final eligibility decision.
Where it's taking place
- Frankfurt a.M., Frankfurt a.M., Germany
- Cologne, Germany
- Münster, Germany
- Tübingen, Germany
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Frankfurt a.M., Frankfurt a.M., Germany; Cologne, Germany; Münster, Germany; Tübingen, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.