Non-Invasive Neuromodulation in MS Induced Spastic Paraparesis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Improvement of T25FWT (Timed 25-Foot Walk Test)
研究概览
简要总结
Study the impact of rTMS on walking ability in people with Multiple Sclerosis (MS) induced spastic paraparesis and moderate walking disability.
详细描述
Measure the impact of rTMS on overall disability level, walking endurance, quality of life parameters, and corroborate with EEG parameters of neural synchrony in patients with MS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Age ≥ 18 years and less than 71 years.
- •Diagnosis of MS according to the revised 2017 McDonald Criteria (Thompson et al. 2018).
- •EDSS of 3.0 to 6.5 with a pyramidal functional system score of 3.0 or more.
- •Neurologically stable with no change in symptom related medications or relapse for at least 30 days prior to screening.
- •Patients will be allowed to continue fampridine provided they started more than 30 days prior to screening. They will not be allowed to start fampridine, any stimulant (modafenil, methylphenidate etc) or symptomatic treatment of spasticity (baclofen, tizanidine, botulinum toxin etc.) during the study.
- •No change in disease modifying therapy for at least 3 months prior to screening.
- •Ability to perform T25FWT, the MSQoL 6MWT Ability and willingness, in the investigator's opinion, to comply with the study protocol.
排除标准
- •Know presence of other neurologic disorders, which in the opinion of the investigator could add to the patient's neurological disability within the timespan of the study.
- •Evidence of clinically significant cardiovascular (including arrhythmias), psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, or gastrointestinal disease that, in the investigator's opinion, would preclude patient participation.
- •Pregnant or breastfeeding or intending to become pregnant during the study.
- •Any previous rTMS therapy for any indication.
- •Presence of any contraindication to rTMS therapy such as but not limited to: CNS implanted devices, pacemaker.
- •Any condition which in the opinion of the investigator will render the patient unsuitable to participate in the study.
结局指标
主要结局
Improvement of T25FWT (Timed 25-Foot Walk Test)
时间窗: 18 weeks
The difference in the number of patients who achieved an improvement of 20% or more from their baseline T25FWT between those that received 6 weeks of sham rTMS and those that received 6 weeks of rTMS
Improvement of T25FWT (Timed 25-Foot Walk Test)
时间窗: 18 weeks
The difference in the number of patients who achieved an improvement of 20% or more from their baseline T25FWT between those that received 6 weeks of sham rTMS and those that received 6 weeks of rTMS
次要结局
- 6MWT (Six minute Walk Test)(12 weeks)
- MSQoL (Multiple Sclerosis Quality of Life)(12 weeks)
- 6MWT (Six minute Walk Test)(12 weeks)
- MSQoL (Multiple Sclerosis Quality of Life)(12 weeks)