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

NCT07190092 | Recruiting

• 1 other identifier: KB 314/2023
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Post Stroke Spasticity; Dystonia

Keywords

dentate nucleus; DRTt; dentate-rubro-thalamic tract; deep brain stimulation; post-stroke spasticity; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Increase of FMA score after the rehabilitation with stimulation dentate-rubro-thalamic tract.

  Increase of FMA score after the rehabilitation

  6 weeks

Secondary Outcomes (3)

• Decrease of Ashworth Scale score after the rehabilitation with dentate-rubro-thalamic tract

  6 weeks

• Improvement in motor function achieves in Motor Assessment Scale MAS with stimulation dentate-rubro-thalamic tract

  6 weeks

• Improvement in Modified Rankin Scale after the rehabilitation with stimulation of dentato-rubro-thalamic tract

  6 weeks

Study Arms (3)

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.

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.

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.

Procedure: Deep brain stimulation electrode implantation with an electrode target in the dentate nucleus

Interventions

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.

High-frequency stimulation; Low-frequency stimulation; No stimulation

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jan Biziel University Hospital No 2 in Bydgoszcz: lead

Study Sites (1)

Department of Neurosurgery and Neurology University Hospital nr 2 Collegium Medicum Nicolaus Copernicus University

Bydgoszcz, 85-168, Poland

RECRUITING

MeSH Terms

Conditions

Dystonia

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Paweł Sokal, Ph.D.

CONTACT

+48600954415; pawel.sokal@cm.umk.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Neurosurgery and Neurology

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 24, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

PL (1)