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

Last updated: November 20, 2023
Sponsor: University Hospital Tuebingen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Thrombosis

Stroke

Cardiac Ischemia

Treatment

Bossdevice

Clinical Study ID

NCT05600374
BOSS-STROKE
01KG2125
CIV-22-01-038788
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria: Subjects meeting all of the following criteria will be considered for admission to thetrial:

  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 daysago.
  3. Subject understands and voluntarily signs an informed consent document prior to anystudy 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 beobtained in the resting muscle o If no MEPs can be obtained, MEP search procedure can be repeated later up to 14 daysafter stroke onset.
  6. ● μ-oscillation (8-12 Hz) is recordable by EEG in the ipsilesional sensorimotor cortexwith a sufficient signal-to-noise ratio of at least 3 dB
  7. ● Subject is able to adhere to the study visit schedule and other protocolrequirements.

Exclusion

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; hemorrhagictransformation 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 theTMS 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-cardiacdefibrillators).
  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 ahigh risk of insurance law issues intervening between two studies. In case ofuncertainty, 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 thesubject in the study or for any other reason the investigator considers the subjectinappropriate for participation in the study.
  14. The ability to consent for patients who are unable to speak will be assessed on thebasis of the NIHS-Score by an independent physician (details see chapter 21 andappendix).

Study Design

Total Participants: 144
Treatment Group(s): 1
Primary Treatment: Bossdevice
Phase:
Study Start date:
February 06, 2023
Estimated Completion Date:
February 28, 2026

Study Description

High-frequency rTMS will be applied to the ipsilesional motor cortex in 400 bursts of 100 Hz triplets with a mean inter-burst interval of 3 s (20 min treatment duration, 1,200 pulses per day) for 5 consecutive workdays (6,000 pulses total) at a stimulus intensity of 80% of resting motor threshold, in one of three conditions/arms, followed by 40 min task-specific hand/arm-physiotherapy.

Connect with a study center

  • Universitätsklinikum Frankfurt, Zentrum der Neurologie und Neurochirurgie

    Frankfurt a.M., 60528
    Germany

    Site Not Available

  • Universitätsmedizin Greifswald, Klinik und Poliklinik für Neurologie

    Greifswald, 17475
    Germany

    Site Not Available

  • Uniklinik Köln, Klinik und Poliklinik für Neurologie

    Köln, 50937
    Germany

    Site Not Available

  • Universitätsklinikum Leipzig, Klinik und Poliklinik für Neurologie

    Leipzig, 04103
    Germany

    Site Not Available

  • Universitätsmedizin Mainz, Klinik und Poliklinik für Neurologie

    Mainz, 55131
    Germany

    Site Not Available

  • Universitätsklinikum Münster, Klinik für Allgemeine Neurologie

    Münster, 48149
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen, Klinik für Neurologie

    Tübingen, 72076
    Germany

    Active - Recruiting

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