Deep Anterior Cerebellar Stimulation in Treatment of Poststroke Spasticity and Motor Function Impairment.
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Deep brain stimulation electrode implantation with an electrode target in the dentate nucleus.
- Who it may be relevant to
- Registry conditions: Post Stroke Spasticity, Dystonia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 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.
Interventions
- Procedure 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.
Primary outcome measures
- Increase of FMA score after the rehabilitation with stimulation dentate-rubro-thalamic tract. [Time frame: 6 weeks]
Secondary outcome measures (3)
- Decrease of Ashworth Scale score after the rehabilitation with dentate-rubro-thalamic tract [Time frame: 6 weeks]
- Improvement in motor function achieves in Motor Assessment Scale MAS with stimulation dentate-rubro-thalamic tract [Time frame: 6 weeks]
- Improvement in Modified Rankin Scale after the rehabilitation with stimulation of dentato-rubro-thalamic tract [Time frame: 6 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Poland · 1 center
- Department of Neurosurgery and Neurology University Hospital nr 2 Collegium Medicum Nicola — Bydgoszcz
Identifiers
NCT: NCT07190092 · KB 314/2023