Brain-Zap timed to your waves may boost stroke recovery
NCT ID NCT05600374
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a noninvasive brain stimulation technique, timed to the patient's own brain waves, can improve arm and hand movement after an ischemic stroke. Researchers will enroll 144 adults who had a stroke 1-14 days ago and have significant arm weakness. Participants receive either real synchronized stimulation, unsynchronized stimulation, or a sham (placebo) treatment, and their motor function is measured right after and again at 3 months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 144 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2023
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Uniklinik Köln, Klinik und Poliklinik für Neurologie
RECRUITINGCologne, 50937, Germany
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Universitätsklinikum Frankfurt, Zentrum der Neurologie und Neurochirurgie
RECRUITINGFrankfurt a.M., Frankfurt a.M., 60528, Germany
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Universitätsklinikum Münster, Klinik für Allgemeine Neurologie
RECRUITINGMünster, 48149, Germany
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Universitätsklinikum Tübingen, Klinik für Neurologie
RECRUITINGTübingen, 72076, Germany
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