TMS for Treatment of Spasticity in Patients With MND
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- safety of rTMS in subjects with PLS/UMN/MND. Number of participants with treatment related AE's will be measured with stringent stopping rules and reported. We hypothesize that no serious treatment related adverse event.
研究概览
简要总结
This is an open-label clinical trial to determine the safety and efficacy of rTMS in reducing spasticity and improving quality of life among patients with upper motor neuron predominant motor neuron disease (MND).
详细描述
The study's objective is to evaluate the role of rTMS for symptom reduction of spasticity among patients with upper motor neuron predominant motor neuron disease. This study is 12-week open label safety and efficacy trial. A total of 10 subjects with PLS and UMN/ MND will be enrolled in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age ≥ 18, men or woman
- •Diagnosis of upper motor neuron predominant ALS, which also includes patients with primary lateral sclerosis (PLS), as defined as only upper motor neuron features in at least 2 body segments.
- •EMG within 3 months of enrollment with minimal or no evidence of lower motor neuron disease.
- •Time from symptom onset > 18 months
- •On a stable dose of, or has not taken, Riluzole for at least thirty days.
- •Has not taken, or has received at least 2 cycles of dosing of, Edaravone prior to screening.
- •Able to communicate clearly the desire to withdraw from the procedure at any stage.
- •Impaired walking as measured by a Hauser Ambulation index of greater than 1 and less than 7 (2 to 6, inclusive).
- •MMSE ≥ 22 and deemed by the PI as being capable of providing informed consent and following trial procedure.
- •Has spasticity, equal or above 1 in the Ashworth Scale for spasticity in 2 or more muscle group of at least 3 months duration.
- •Absence of
排除标准
- •Exclusion criteria
- •Patient has a history of drug or alcohol abuse within the past year;
- •Patient has clinically significant abnormal laboratory values.
- •Any concomitant disease or disorder that has spasticity-like symptoms or that may influence the subject's level of spasticity
- •Received Botulinum Toxin during the preceding 6 months
- •Bedridden and patients with tracheostomy.
- •Fixed-tendon contractures
- •Poorly controlled epilepsy or recurrent seizures (Subjects who have had one or more seizures in the year prior to Visit 1 will be excluded)
- •Unable to provide an informed consent
- •Unable to comply with the procedures
- •Unable to communicate clearly if the subject wants to withdraw from the procedure at any stage
- •History of brain surgery for any indication
- •Has pacemaker, cochlear implants, brain stimulators, infusion pumps, intracardiac lines, metallic clips, other implanted electronic or ferroelectric metallic devices above the neck (Dental implants are permitted), piercing or body modification above the neck, known history of TMS related complications or side effects.
- •Female patients of child bearing period who are not practicing contraception.
- •Female patients who are pregnant.
- •Inability to perform either rTMS due to insufficient MEP amplitude (< 50 µv).
结局指标
主要结局
safety of rTMS in subjects with PLS/UMN/MND. Number of participants with treatment related AE's will be measured with stringent stopping rules and reported. We hypothesize that no serious treatment related adverse event.
时间窗: from week 0 to the end of the study, an average of 5 months.
Transcranial magnetic stimulation is a non-invasive procedure used to stimulate small regions of the brain. The effect of rTMS on spasticity was studied in patients with stroke, MS, SCI and CP and found to be safe (4). There are no studies assessing safety of rTMS in patients with PLS and UMN/ MND with spasticity. Because it is so well tolerated in other diseases, we anticipate no adverse effects. However, we will systematically assess all adverse effects with stringent stopping rules for individual patients and the study. We hypothesize that no patient will have a serious treatment related adverse event. Therefore we will track the number of Participants With Treatment-Related AE as Assessed by CTCAE v4.0
次要结局
- To evaluate efficacy of rTMS using a modified FDA approved protocol in research subjects with PLS and UMN/MND.(From week 0 to end of the study, an average of 5 months)