Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05600374

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

Led by University Hospital Tuebingen · Updated on 2026-05-15

144

Participants Needed

4

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the therapeutic effects of EEG-synchronized noninvasive repetitive transcranial magnetic stimulation (rTMS) on upper limb motor recovery in patients during the early subacute phase after ischemic stroke. The study aims to determine if synchronizing rTMS with brain oscillations indicating high corticospinal excitability leads to better improvement in motor function compared to non-synchronized or sham stimulation. This investigation is led by the University Hospital Tuebingen and focuses on improving rehabilitation outcomes after stroke. The study involves applying high-frequency rTMS to the affected motor cortex in three different ways: synchronized with brain oscillations indicating high excitability, non-synchronized stimulation, and sham stimulation using a placebo coil. Treatments are given as 400 bursts of 100 Hz triplets over 20 minutes per day, for 5 consecutive workdays, totaling 6,000 pulses at 80% of resting motor threshold. After each session, participants receive 40 minutes of task-specific hand and arm physiotherapy. Participants will undergo motor performance assessments immediately after the last treatment session and again after 3 months. Additional evaluations include grip strength, quality of life, modified Rankin Scale, Barthel Index, and rehabilitation status, both at screening and at 3 months post-treatment. The study includes EEG monitoring to detect specific brain oscillations and uses a device to synchronize stimulation accordingly. The total participation duration spans from initial screening through follow-up assessments over several months.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older at the time of signing informed consent
  • Cerebral ischemia confirmed by brain imaging occurred 1 to 14 days prior
  • Ability to understand and voluntarily sign informed consent
  • New arm or hand motor deficit with a FMA-UE score of 50 points or less
  • Presence of motor evoked potentials in the resting muscle of the affected hand
  • Detectable 8-12 Hz mu-oscillation in the affected sensorimotor cortex by EEG with sufficient signal quality
  • Ability to adhere to study visit schedule and protocol requirements
Not Eligible

You will not qualify if you...

  • Hemorrhagic stroke (primary intracerebral hemorrhage)
  • Estimated life expectancy less than 12 months
  • Presence of intracranial ferromagnetic metal incompatible with TMS
  • Intraocular metal or cochlear implants
  • Active implants with sensors that may interact with TMS
  • Cranial bone gap affecting TMS currents (e.g., post-craniotomy)
  • History of seizures or epilepsy
  • Treatment cannot start within 14 days after stroke onset
  • Women who are pregnant or breastfeeding
  • Participation in other high-risk clinical studies with insurance conflicts
  • Persistent addiction disorders except nicotine dependence
  • Central nervous system malignancies
  • Investigator concerns about safety or appropriateness for participation
  • Inability to provide consent if unable to speak, assessed by independent physician using NIH Stroke Scale score

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 5 consecutive workdays

Participants receive high-frequency rTMS synchronized to brain oscillations or control stimulation, followed by task-specific hand/arm physiotherapy over 5 consecutive workdays.

5 daily visits (in-person)

Follow-up

Duration - 3 months

Participants are assessed for motor performance, grip strength, quality of life, and functional status after treatment and at 3 months.

1 visit after treatment and 1 visit at 3 months (in-person)

Trial Site Locations

Total: 4 locations

1

Universitätsklinikum Frankfurt, Zentrum der Neurologie und Neurochirurgie

Frankfurt a.M., Frankfurt a.M., Germany, 60528

Actively Recruiting

2

Uniklinik Köln, Klinik und Poliklinik für Neurologie

Cologne, Germany, 50937

Actively Recruiting

3

Universitätsklinikum Münster, Klinik für Allgemeine Neurologie

Münster, Germany, 48149

Actively Recruiting

4

Universitätsklinikum Tübingen, Klinik für Neurologie

Tübingen, Germany, 72076

Actively Recruiting

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Research Team

U

Ulf Ziemann, Prof. Dr.

S

Sven Poli, Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Brain-oscillation-synchronized stimulation to enhance motor recovery in early subacute stroke: a randomized controlled double-blind three- arm parallel-group exploratory trial comparing personalized, non- personalized and sham repetitive transcranial magnetic stimulation (Acronym: BOSS-STROKE).

Anne Lieb, Brigitte Zrenner, Christoph Zrenner...

https://pubmed.ncbi.nlm.nih.gov/37231390