Using brain stimulation to improve motor recovery after stroke

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

This study is testing if a special brain stimulation technique can help people recover better movement in their arms after having a stroke.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital Tuebingen (other)
• Locations: 7 sites (Frankfurt a.M. and 6 other locations)
• Trial ID: NCT05600374 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of EEG-synchronized repetitive transcranial magnetic stimulation (rTMS) to enhance upper limb motor rehabilitation in patients who have recently suffered an ischemic stroke. The approach involves applying high-frequency rTMS to the motor cortex of the affected side of the brain, synchronized with ongoing brain oscillations to potentially improve motor function more effectively than non-synchronized or sham stimulation. Participants will receive 20 minutes of rTMS followed by 40 minutes of task-specific physiotherapy over five consecutive days.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have experienced a recent ischemic stroke with measurable motor deficits.

Not a fit: Patients who do not exhibit motor evoked potentials or have severe motor deficits may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve motor recovery in stroke patients, enhancing their quality of life and independence.

How similar studies have performed: Previous studies have shown promising results with rTMS in stroke rehabilitation, suggesting that this synchronized approach may build on established methods.

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).

Where this trial is running

Frankfurt a.M. and 6 other locations

• Universitätsklinikum Frankfurt, Zentrum der Neurologie und Neurochirurgie — Frankfurt a.M., Germany (NOT_YET_RECRUITING)
• Universitätsmedizin Greifswald, Klinik und Poliklinik für Neurologie — Greifswald, Germany (NOT_YET_RECRUITING)
• Uniklinik Köln, Klinik und Poliklinik für Neurologie — Köln, Germany (NOT_YET_RECRUITING)
• Universitätsklinikum Leipzig, Klinik und Poliklinik für Neurologie — Leipzig, Germany (NOT_YET_RECRUITING)
• Universitätsmedizin Mainz, Klinik und Poliklinik für Neurologie — Mainz, Germany (NOT_YET_RECRUITING)
• Universitätsklinikum Münster, Klinik für Allgemeine Neurologie — Münster, Germany (NOT_YET_RECRUITING)
• Universitätsklinikum Tübingen, Klinik für Neurologie — Tübingen, Germany (RECRUITING)

Study contacts

• Study coordinator: Ulf Ziemann, Prof. Dr.

Conditions: Ischemic Stroke, Acute