Open Label Study for the Use of Transcranial Ultrasound for Treatment of Age-Related Frailty
试验速览
- 阶段
- 早期 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Clinical Frailty Scale (CFS)
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 age-related frailty.
详细描述
This study is designed to evaluate the safety and efficacy of focused ultrasound in patients with age-related frailty characterized by reduced physical and immunological functioning. 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
- 45 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age eligibility requirements fall in a range from 60 to 95 years of age
- •Clinical appraisal by physician indicating signs of frailty (apart from a co-occuring condition), scoring 3<x<7 as denoted by the CSHA Clinical Frailty Scale (Rockwood, Song, MacKnight, et al, 2005; Golpanian, DiFede, Pujol, et al., 2016)
- •MRI of the brain including volume measurement of the hypothalamus
排除标准
- •Subjects unable to give informed consent
- •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
- •Advanced terminal illness
- •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
Clinical Frailty Scale (CFS)
时间窗: Final Evaluation (8 weeks from baseline)
The CFS is a 9-point scoring guide for physicians to use upon clinical appraisal of frailty-related symptoms. The lowest rating is 1 ("Very Fit") and the highest rating is 9 ("Terminally Ill"). The range of acceptable ratings for screened participants is from 3 ("Managing Well") to 7 ("Severely Frail"). Scoring on the CFS will be noted as significant for those who improve by at least one level.
次要结局
- Multidimensional Fatigue Inventory (MFI)(Final Evaluation (8 weeks from baseline))
- Montreal Cognitive Assessment (MoCA)(Final Evaluation (8 weeks from baseline))
- Beck Depression Inventory (BDI-II)(Final Evaluation (8 weeks from baseline))
- Beck Anxiety Inventory (BAI)(Final Evaluation (8 weeks from baseline))
- Grip Strength (Dynamometer Performance)(Final Evaluation (8 weeks from baseline))
- Short Physical Performance Battery (SPPB)(Final Evaluation (8 weeks from baseline))
- Community Healthy Activities Model Program for Seniors (CHAMPS)(Final Evaluation (8 weeks from baseline))
- Global Rating of Change (GRC)(Final Evaluation (8 weeks from baseline))