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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJan Biziel University Hospital No 2 in Bydgoszcz

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Seizures after the stroke

Depression

Severe sensory deficits

Anosognosia

Trial design

Treatments tested in this trial

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

Treatment groups

12 Participants
are divided into 3 treatment groups