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

NCT07190092 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-09-24

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Jan Biziel University Hospital No 2 in Bydgoszcz

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2027-12-30
Completion
2028-12-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07190092 on ClinicalTrials.gov