NCT06763692尚未招募不适用
Early Feasibility Study of Low-Intensity Focused Ultrasound (LIFU) Neuromodulation in Patients With Parkinson's Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Ali Rezai
- 入组人数
- 15
- 主要终点
- Occurrence of Treatment Emergent Adverse Events
研究概览
简要总结
This study is a prospective, single-center, single-arm early feasibility study, to establish safety and tolerability of LIFU for neuromodulation in patients with parkinson's Disease
详细描述
The primary objective is to evaluate the safety, feasibility and tolerability of LIFU as an adjunct neuromodulatory treatment for Parkinson's Disease
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and non-pregnant females aged 45 - 80 years at time of enrollment.
- •Able and willing to give informed consent.
- •Diagnosis of probable idiopathic Parkinson's disease by United Kingdom Parkinson's Disease
- •Clinical diagnosis based on the Level II Movement Disorder Criteria and an FAQ less than or equal to
- •If on medication for the treatment of PD, or other medications for any other underlying medical conditions, must be on a stable dose for ≥4 weeks prior to Screening.
- •Willing to not receive DBS or any other approved or experimental surgical or medical therapy for PD during the study period.
- •Males and non-pregnant females aged 45 - 80 years at time of enrollment.
- •Able and willing to give informed consent.
- •Diagnosis of probable idiopathic Parkinson's disease by United Kingdom Parkinson's Disease
- •Clinical diagnosis based on the Level II Movement Disorder Criteria and an FAQ less than or equal to
- •If on medication for the treatment of PD, or other medications for any other underlying medical conditions, must be on a stable dose for ≥4 weeks prior to Screening.
- •Willing to not receive DBS or any other approved or experimental surgical or medical therapy for PD during the study period.
排除标准
- •Unable to undergo MR-imaging because of non-MR compatible implants (e.g., pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent make-up or small metal fragments in the eye that welders and other metal workers may have), or if candidates are uncomfortable in small spaces (have claustrophobia).
- •Active or chronic infection/inflammation
- •Acute or chronic hemorrhages, specifically any lobar microbleeds with GRE and no siderosis or macro hemorrhages
- •Tumor/space occupying lesion anywhere in the brain
- •Participants who are unable or unwilling to lay flat and tolerate the required prolonged stationary position during treatment (approximately 2-3 hours).
- •Participants with more than 30% of the skull area traversed by the sonication pathway are covered by scars, scalp disorders (e.g., eczema), atrophy of the scalp, or implanted objects in the skull or the brain.
- •Participants with known unstable cardiac status or uncontrolled hypertension
- •History of any clinically significant neurological disorder or procedure (e.g., brain surgery for Parkinson's disease, tumors, uncontrolled epilepsy, or any others deemed clinically significant by the investigator).
- •Participant who has had deep brain stimulation or a prior stereotactic ablation of the basal ganglia, or thalamus.
- •Currently participating in another clinical investigation with an active treatment arm or participated in any experimental therapy (drug or biologic or device) within 3 months prior to Screening.
- •Use of any medications that, in the opinion of the Investigator, may contribute to cognitive impairment, put the participant at higher risk for AEs, or impair the participant's ability to perform cognitive testing or complete study procedures.
研究组 & 干预措施
LIFU Neuromodulation
Experimental
干预措施: LIFU Neuromodulation (Device)
结局指标
主要结局
Occurrence of Treatment Emergent Adverse Events
时间窗: baseline and day 7, 30 and 90 after study procedure
All adverse events that are related to LIFU will be assessed
次要结局
- Effect of LIFU on visuospatial function,(baseline and day 7, 30 and 90 after study procedure)
研究者
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