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

Jan Biziel University Hospital No 2 in Bydgoszcz

Status: Enrolling

Conditions: Dystonia; Post Stroke Spasticity

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07190092

KB 314/2023

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12 participants in 3 patient groups

High-frequency stimulation

Experimental group

Description:

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.

Treatment:

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

Low-frequency stimulation

Experimental group

Description:

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.

Treatment:

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

No stimulation

Sham Comparator group

Description:

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.

Treatment:

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