Open Label Study for the Use of Transcranial Ultrasound Treatment of Tremor
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Essential Tremor Rating Assessment Scale (TETRAS)
研究概览
简要总结
The purpose of this Phase I open label study is to evaluate longer term tolerability and potential effectiveness of transcranial ultrasound in people with tremor as a results of Parkinson's Disease or Essential Tremor.
详细描述
This study is designed to evaluate the safety and efficacy of focused ultrasound in patients with Parkinson's Disease or Essential Tremor characterized by tremor. The safety of this protocol will be closely monitored and data will be used to determine whether any significant safety issues exist when using focused ultrasound. Adverse events will be noted whenever they occur but will be recorded at the time of the procedure and throughout routine follow-ups, which will persist weekly throughout the duration of the active study protocol. Patients deemed potentially appropriate candidates for focused ultrasound therapy will be treated with 8 sessions of transcranial ultrasound, each of which consists of 10 to 30 minutes of active administration. Clinical and safety outcome measures will be obtained throughout and after completion of the study protocol.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order for a subject to be considered for the Essential Tremor application of this study, the following criteria are required:
- •Subjective complaint of tremor assessed and validated by physician
- •Must be willing to comply with the study protocol
- •English Proficiency
- •At least 18 years of age
- •At most 90 years of age
- •In order for a subject to be considered for the Parkinson's Disease application of this study, the following criteria are required:
- •Diagnosis of Parkinson's Disease validated by physician
- •Must be willing to comply with the study protocol
- •English Proficiency
- •At least 18 years of age
- •At most 90 years of age
排除标准
- •In order for a subject to be considered for this study, he/she may NOT have any of the following:
- •Subjects not English proficient
- •Subjects unable to give informed consent
- •Subjects do not meet age requirements (18-90)
- •Subjects who would not be able to lay down without excessive movement in a calm environment sufficiently long enough to be able to achieve sleep
- •Pregnancy, women who may become pregnant or are breastfeeding
- •Women with child-bearing potential who are not willing to use a double-barrier birth control method
- •Males not willing to use a double-barrier birth control method with female sex partners with child-bearing potential
- •Advanced terminal illness
- •Any active cancer or chemotherapy
- •Any other neoplastic illness or illness characterized by neovascularity
- •Macular degeneration
- •Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer)
结局指标
主要结局
Essential Tremor Rating Assessment Scale (TETRAS)
时间窗: Through Completion of Study (Average time 8-weeks)
The Essential Tremor Rating Assessment Scale was developed by the Tremor Research Group to quantify essential tremor severity and its impact on activities of daily living. The ADL section of TETRAS has 12 items, each rated 0, 1, 2, 3 or 4. The maximum total score is 48. Item 1 addresses speech; item 10 addresses occupational impairment; and item 12 assesses social impact. The other 9 items assess activities that are affected primarily by upperweighting of lower limb tremor in the total performance score.
次要结局
- Parkinson's Activities of Daily Living Scale (PAD-L)(Through Completion of Study (Average time 8-weeks))
- 9 Hole Pegboard Task (9 HPT)(Through Completion of Study (Average time 8-weeks))