Post Stroke SpasticityNCT07190092
Deep Anterior Cerebellar Stimulation in Treatment of Poststroke Spasticity and Motor Function Impairment.
A study testing Deep brain stimulation electrode implantation with an electrode target in the dentate nucleus in people with Post Stroke Spasticity and Dystonia, run by Jan Biziel University Hospital No 2 in Bydgoszcz at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Stroke Spasticity, Dystonia
- What is being tested?
- Deep brain stimulation electrode implantation with an electrode target in the dentate nucleus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2024to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of Neurosurgery and Neurology University Hospital nr 2 Collegium Medicum Nicolaus Copernicus University
Bydgoszcz, 85-168
Paweł Sokal, Ph.D., +48600954415, pawel.sokal@cm.umk.pl
Magdalena Jabłońska, M.D., +48 784 019 156, magdalena.jablonska14@gmail.com
About this study
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:
Read more
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.
- Conditions
- Post Stroke Spasticity, Dystonia
- Being tested
- Deep brain stimulation electrode implantation with an electrode target in the dentate nucleus
- Keywords
- dentate nucleus, DRTt, dentate-rubro-thalamic tract, deep brain stimulation, post-stroke spasticity, rehabilitation
- Medical subject headings
- Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulation electrode implantation with an electrode target in the dentate nucleusProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Deep brain stimulation electrode implantation with an electrode target in the dentate nucleus |
| 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. Receives: Procedure: Deep brain stimulation electrode implantation with an electrode target in the dentate nucleus |
| 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. Receives: Procedure: Deep brain stimulation electrode implantation with an electrode target in the dentate nucleus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase of FMA score after the rehabilitation with stimulation dentate-rubro-thalamic tract.
Increase of FMA score after the rehabilitation
Measured: 6 weeks
Secondary outcomes (3)
Decrease of Ashworth Scale score after the rehabilitation with dentate-rubro-thalamic tract
Decrease of Ashworth Scale score
Measured: 6 weeks
Improvement in motor function achieves in Motor Assessment Scale MAS with stimulation dentate-rubro-thalamic tract
Improvement in motor function achieves in Motor Assessment Scale
Measured: 6 weeks
Improvement in Modified Rankin Scale after the rehabilitation with stimulation of dentato-rubro-thalamic tract
Improvement in Modified Rankin Scale
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start1 Sep 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Stroke SpasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jan Biziel University Hospital No 2 in Bydgoszcz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pawel Sokal, Jan Biziel University Hospital No 2 in Bydgoszcz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190092
- Sponsor's protocol ID
- KB 314/2023
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Anterior Cerebellar Stimulation in Treatment of Poststroke Spasticity and Motor Function Impairment.
- ClinicalTrials.gov ID
- NCT07190092
- Acronym / sponsor ID
- KB 314/2023
- Conditions
- Post Stroke Spasticity, Dystonia
- Keywords
- dentate nucleus, DRTt, dentate-rubro-thalamic tract, deep brain stimulation, post-stroke spasticity, rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Jan Biziel University Hospital No 2 in BydgoszczUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-frequency stimulation | Experimental | Procedure: Deep brain stimulation electrode implantation with an electrode target in the dentate nucleusPatients 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 | Procedure: Deep brain stimulation electrode implantation with an electrode target in the dentate nucleusPatients 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 | Procedure: Deep brain stimulation electrode implantation with an electrode target in the dentate nucleusPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Seizures after the stroke
- Depression
- Severe sensory deficits
- Anosognosia
- Moderate to severe hemispatial neglect
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep brain stimulation electrode implantation with an electrode target in the dentate nucleusThe 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. | Procedure or surgery | High-frequency stimulation, Low-frequency stimulation, No stimulation |
Primary outcome
Increase of FMA score after the rehabilitation with stimulation dentate-rubro-thalamic tract.
Time frame: 6 weeks
Increase of FMA score after the rehabilitation
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep brain stimulation electrode implantation with an electrode target in the dentate nucleus in people with Post Stroke Spasticity and Dystonia, run by Jan Biziel University Hospital No 2 in Bydgoszcz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paweł Sokal, Ph.D. (+48600954415, pawel.sokal@cm.umk.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase of FMA score after the rehabilitation with stimulation dentate-rubro-thalamic tract. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.