Neuromuscular Electrical Stimulation for Jaw-closing Dystonia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Jaw Opening
研究概览
简要总结
6 patients with jaw-closing dystonia will be treated with neuromuscular electrical stimulation over 8 weeks. The distance the mouth can be opened voluntarily and the oro-mandibular dystonia questionnaire (OMDQ-25) will be employed to determine whether there is any objective change in jaw opening or evidence of functional improvement.
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
- •Jaw-closing dystonia, which may be primary or secondary to a neurodegenerative disease or medications.
- •Unable to voluntarily open jaw fully on examination.
- •Evidence of functional impairment resulting from dystonia including inability to completely open the jaw during speaking or eating to such an extent that it interferes with these tasks.
- •Patient interested in participating, and willing to attend multiple treatment sessions in the neurology clinic.
排除标准
- •Presence of a cardiac pacemaker, implanted defibrillator, or other implanted electronic device.
- •Inability to provide consent (either by the patient, spouse, or an identified power of attorney).
- •Age under 18 years.
- •Pregnancy.
研究组 & 干预措施
Neuromuscular electrical stimulation
The Omnistim® FX² is a neuromuscular stimulation device that provides patterned electrical neuromuscular stimulation (PENS) via cutaneous electrodes placed over relevant musculature. It will be applied for 20 minutes per session. For each patient, there will be 2 sessions per week, spaced 3 to 4 days apart. Each patient will participate in 16 sessions over the 8 weeks of the study. There will be 6 patients total.
干预措施: Omnistim® FX² (Device)
结局指标
主要结局
Jaw Opening
时间窗: Average change from before to after each 20-minute treatment session.
Measured via tongue depressor quantity, which is the number of stacked tongue depressors the patient is able to safely fit between his or her incisors.
Oromandibular Dystonia Questionnaire
时间窗: Change from before the first treatment to after the last treatment, usually over 8 weeks.
Questionnaire that assesses quality of life in oromandibular dystonia patients. There are 25 questions total, and each question may be answered as never, seldom, sometimes, often, always. Minimum score is 0, maximum score is 100. A higher score indicates worse quality of life.
Jaw Opening
时间窗: Change from before starting first treatment to after completing last treatment, usually completed over 8 weeks.
Measured via tongue depressor quantity, which is the number of stacked tongue depressors the patient is able to safely fit between his or her incisors.
次要结局
未报告次要终点
研究者
Edward Burton
Associate Professor
University of Pittsburgh