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Deep Anterior Cerebellar Stimulation in Treatment of Poststroke Spasticity and Motor Function Impairment.

RecruitingNAAges 18 Years - anyAllJan Biziel University Hospital No 2 in Bydgoszcz
NCT07190092 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The aim of this clinical trial is to determine whether deep brain stimulation (DBS) interventions improve rehabilitation and functional recovery in patients with post-stroke spasticity who meet the other inclusion criteria listed below. Primary question(s) to be answered: Is DBS stimulation effective in treating post-stroke spasticity? What stimulation frequency is most effective in treating post-stroke spasticity? Study participants will: * Undergo surgery to implant a DBS electrode targeting the DRTt (dentate-rubro-thalamic tract ) in close proximity of the dentate nucleus of the cerebellum ipsilateral to the spastic side of the body. * Each patient will then receive an initial stimulation frequency of 130 Hz (arm 1) and will be assigned to a 4- to 6-week rehabilitation program. After this period, the participant will return for a follow-up visit for a clinical evaluation. * The fr

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📋 Eligibility rules (as published)
Inclusion Criteria: * One time stroke that occurred 9-36 months ago * Ischemic or hemorrhagic stroke * Spastic paresis of at least one limb * At least 3 months of poststroke rehabilitation in the past * No improvement of spasticity/motor function for at least 3 months Exclusion Criteria: * Seizures after the stroke * Depression * Severe sensory deficits * Anosognosia * Moderate to severe hemispatial neglect * Others contraindications for the DBS procedure, e.g. coagulopathy, decompensated chronic disease, etc. * Contraindication for MRI * No poststroke rehabilitation
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What it tests

  • Deep brain stimulation electrode implantation with an electrode target in the dentate nucleus
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Where

1 site
Department of Neurosurgery and Neurology University Hospital nr 2 Collegium Medicum Nicolaus Copernicus University
Bydgoszcz, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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