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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Subjects 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.

Locations
Other Locations
Germany
Uniklinik Köln, Klinik und Poliklinik für Neurologie
NOT_YET_RECRUITING
Cologne
Universitätsklinikum Frankfurt, Zentrum der Neurologie und Neurochirurgie
NOT_YET_RECRUITING
Frankfurt A.m.
Universitätsmedizin Greifswald, Klinik und Poliklinik für Neurologie
NOT_YET_RECRUITING
Greifswald
Universitätsklinikum Leipzig, Klinik und Poliklinik für Neurologie
NOT_YET_RECRUITING
Leipzig
Universitätsmedizin Mainz, Klinik und Poliklinik für Neurologie
NOT_YET_RECRUITING
Mainz
Universitätsklinikum Münster, Klinik für Allgemeine Neurologie
NOT_YET_RECRUITING
Münster
Universitätsklinikum Tübingen, Klinik für Neurologie
RECRUITING
Tübingen
Contact Information
Primary
Ulf Ziemann, Prof. Dr.
Ulf.Ziemann@med.uni-tuebingen.de
+49 7071 29
Backup
Sven Poli, Dr.
sven.poli@med.uni.tuebingen.de
Time Frame
Start Date: 2023-02-06
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 144
Treatments
Experimental: Personalized stimulation
Each 100 Hz triplet is triggered when a real-time analyzed EEG-defined state of high corticospinal excitability is detected (i.e., the negative peak of the ongoing sensorimotor \~10 Hz μ-oscillation).
No_intervention: Non-personalized stimulation
The identical rTMS protocol as in Arm 1, but 100 Hz triplets are not synchronized to the ongoing sensorimotor μ-oscillation.
No_intervention: Sham stimulation
The same protocol as in arm 1 synchronized to the EEG-defined high excitability state, but with ineffective rTMS, using the sham side of an active/placebo TMS coil designed for double-blind clinical trials. Conditions/arm 2 and 3 are control conditions. Arm 2 controls for the specific effect of Condition/arm 1 to synchronize stimulation to the ongoing μ-oscillation. Arm 3 tests if auditory or somatosensory inputs (which are identical in the real and sham stimulation conditions) synchronized with the ongoing μ-oscillation are relevant for the effects of Arm 1.
Related Therapeutic Areas
Sponsors
Leads: University Hospital Tuebingen

This content was sourced from clinicaltrials.gov