Deep Anterior Cerebellar Stimulation in Treatment of Poststroke Spasticity and Motor Function Impairment.
NCT ID: NCT07190092
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
12 participants
INTERVENTIONAL
2024-09-01
2028-12-30
Brief Summary
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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 frequency will then be changed to 70Hz (arm 2). Patients who have undergone this change will also undergo a rehabilitation period of 4 to 6 weeks. After this period, they will return to the Clinic for a follow-up evaluation.
* The frequency will then be changed to 30Hz (arm 3). Patients who have undergone this change will also undergo a rehabilitation period of 4 to 6 weeks.
Researchers will compare the results obtained from patients in each arm to determine the clinical effects of stimulation and whether they are dependent on the stimulation frequency.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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High-frequency stimulation
Patients in this arm of the study will undergo implantation of deep brain stimulation electrodes. The stimulation parameters will include a frequency of 130 Hz, which differentiates this arm from the others. The study duration will be four weeks. At the beginning and end of participation in this arm, patients will be examined and assessed using the previously discussed scales.
Deep brain stimulation electrode implantation with an electrode target in the dentate nucleus
The intervention will involve implantation of a directional electrode with a target in the dentate nucleus of the cerebellum, ipsilateral to the limbs affected by spasticity. Electrode implantation will be performed using a stereotaxic frame, following prior planning of the electrode trajectory and tractography of the dento-ruborothalamic tract using a planning station. The procedure will be performed under general anesthesia. The IPG stimulator will be placed in the subclavicular region.
Low-frequency stimulation
Patients in this arm of the study will have deep brain stimulation electrodes implanted. Stimulation parameters will include a frequency of 50 Hz, which differentiates this arm from the others. The study duration will be four weeks. At the beginning and end of participation in this arm, patients will be examined and assessed using the previously discussed scales.
Deep brain stimulation electrode implantation with an electrode target in the dentate nucleus
The intervention will involve implantation of a directional electrode with a target in the dentate nucleus of the cerebellum, ipsilateral to the limbs affected by spasticity. Electrode implantation will be performed using a stereotaxic frame, following prior planning of the electrode trajectory and tractography of the dento-ruborothalamic tract using a planning station. The procedure will be performed under general anesthesia. The IPG stimulator will be placed in the subclavicular region.
No stimulation
Patients participating in this arm of the study will have deep brain stimulation electrodes implanted. The stimulation will be turned off. The study will last four weeks. At the beginning and end of their participation in this arm, patients will be assessed and rated using the scales discussed earlier.
Deep brain stimulation electrode implantation with an electrode target in the dentate nucleus
The intervention will involve implantation of a directional electrode with a target in the dentate nucleus of the cerebellum, ipsilateral to the limbs affected by spasticity. Electrode implantation will be performed using a stereotaxic frame, following prior planning of the electrode trajectory and tractography of the dento-ruborothalamic tract using a planning station. The procedure will be performed under general anesthesia. The IPG stimulator will be placed in the subclavicular region.
Interventions
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Deep brain stimulation electrode implantation with an electrode target in the dentate nucleus
The intervention will involve implantation of a directional electrode with a target in the dentate nucleus of the cerebellum, ipsilateral to the limbs affected by spasticity. Electrode implantation will be performed using a stereotaxic frame, following prior planning of the electrode trajectory and tractography of the dento-ruborothalamic tract using a planning station. The procedure will be performed under general anesthesia. The IPG stimulator will be placed in the subclavicular region.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Jan Biziel University Hospital No 2 in Bydgoszcz
OTHER
Responsible Party
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Pawel Sokal
Head of Department of Neurosurgery and Neurology
Locations
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Department of Neurosurgery and Neurology University Hospital nr 2 Collegium Medicum Nicolaus Copernicus University
Bydgoszcz, , Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KB 314/2023
Identifier Type: -
Identifier Source: org_study_id
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