NCT05600374 Brain-Oscillation-Synchronized Stimulation to Enhance Motor Recovery in Early Subacute Stroke
| NCT ID | NCT05600374 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Tuebingen |
| Condition | Ischemic Stroke, Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2023-02-06 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 144 participants in total. It began in 2023-02-06 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 1-14 days ago. 3. Subject understands and voluntarily signs an informed consent document prior to any study 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 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. 6. ● 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 7. ● Subject is able to adhere to the study visit schedule and other protocol requirements. 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 from the 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-cardiac defibrillators). 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 otherwise a high risk of insurance law issues intervening between two studies. In case of uncertainty, 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 the subject in the study or for any other reason the investigator considers the subject inappropriate for participation in the study. 14. 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05600374 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ischemic Stroke, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05600374 currently recruiting?
Yes, NCT05600374 is actively recruiting participants. Contact the research team at Ulf.Ziemann@med.uni-tuebingen.de for enrollment information.
Where is the NCT05600374 trial being conducted?
This trial is being conducted at Frankfurt a.M., Germany, Cologne, Germany, Münster, Germany, Tübingen, Germany.
Who is sponsoring the NCT05600374 clinical trial?
NCT05600374 is sponsored by University Hospital Tuebingen. The trial plans to enroll 144 participants.
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