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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-frequency stimulation | Experimental | 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. |
|
| Low-frequency stimulation | Experimental | 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. |
|
| No stimulation | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep brain stimulation electrode implantation with an electrode target in the dentate nucleus | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Increase of FMA score after the rehabilitation with stimulation dentate-rubro-thalamic tract. | Increase of FMA score after the rehabilitation | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease of Ashworth Scale score after the rehabilitation with dentate-rubro-thalamic tract | Decrease of Ashworth Scale score | 6 weeks |
| Improvement in motor function achieves in Motor Assessment Scale MAS with stimulation dentate-rubro-thalamic tract |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paweł Sokal, Ph.D. | Contact | +48600954415 | pawel.sokal@cm.umk.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurosurgery and Neurology University Hospital nr 2 Collegium Medicum Nicolaus Copernicus University | Recruiting | Bydgoszcz | 85-168 | Poland |
All IPD that underlie results in a publication
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|
Improvement in motor function achieves in Motor Assessment Scale
| 6 weeks |
| Improvement in Modified Rankin Scale after the rehabilitation with stimulation of dentato-rubro-thalamic tract | Improvement in Modified Rankin Scale | 6 weeks |
| ID | Term |
|---|---|
| D004421 | Dystonia |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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