NL-OMON48254尚未招募2 期
The effect of the STIL brace on forearm tremor - a double-blind randomized crossover study - Suppression of the forearm tremor with the STIL brace
Reinier de Graaf Groep0 个研究点目标入组 20 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Patients over 18 years old
- •* Competent and willing to sign informed consent
- •* Significant disability due to forearm tremor. (ADL score of 3 or above in one
- •of the upper limb items and a minimum subset score of 38 across all upper limb
- •items. Scored for the most affected hand with the Bain and Findley ADL scale)
排除标准
- •* Excessive alcohol consumption, as defined in the GGZ guidelines
- •* Implanted electrical medical device, such as a pacemaker, defibrillator, or
- •deep brain stimulator
- •* Previous thalamotomy procedure, including stereotactic thalamotomy, gamma
- •knife radio surgical thalamotomy, and focused ultrasound for the treatment of
- •* Change in medication in the 30 days prior to study enrollment
- •* Taking medication known to exacerbate tremor
- •* Suspected or diagnosed epilepsy
- •* Swollen, infected, inflamed areas, or skin eruptions, open wounds, or
- •cancerous lesions of skin at stimulation site.
- •* Peripheral neuropathy affecting the tested upper extremity (e.g. Carpal
- •tunnel syndrome)
- •* Presence of any other neurodegenerative diseases like multisystem atrophy,
- •progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's
- •* Patients diagnosed with a depression
- •* Patients with an amputation of one or both upper extremities.
- •* Subjects with a restricted movement of the arm and or hand (e.g.
- •contractures) or restricted muscle function
- •* Botulinum toxin injection for hand tremor within 6 months prior to study
- •* Alcohol or caffeine consumption within 24 hours of study enrollment.
- •* Heavy physical training within 24 hours of study enrollment
- •* Subjects unable to communicate with the investigator and staff
- •* Subjects with illiteracy
- •* Pregnancy at time of study enrollment
研究者
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