Deep Anterior Cerebellar Stimulation in Treatment of Poststroke Spasticity and Motor Function Impairment.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Increase of FMA score after the rehabilitation with stimulation dentate-rubro-thalamic tract.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
High-frequency stimulation
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.
干预措施: Deep brain stimulation electrode implantation with an electrode target in the dentate nucleus (Procedure)
Low-frequency stimulation
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.
干预措施: Deep brain stimulation electrode implantation with an electrode target in the dentate nucleus (Procedure)
No stimulation
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.
干预措施: Deep brain stimulation electrode implantation with an electrode target in the dentate nucleus (Procedure)
结局指标
主要结局
Increase of FMA score after the rehabilitation with stimulation dentate-rubro-thalamic tract.
时间窗: 6 weeks
Increase of FMA score after the rehabilitation
次要结局
- Improvement in Modified Rankin Scale after the rehabilitation with stimulation of dentato-rubro-thalamic tract(6 weeks)
- 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)
研究者
Pawel Sokal
Head of Department of Neurosurgery and Neurology
Jan Biziel University Hospital No 2 in Bydgoszcz