Effects of Transcranial Focused Ultrasound Stimulation (tFUS) on Neurological and Cognitive Outcomes in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Finger Tapping
研究概览
简要总结
This is a pilot randomized, sham-controlled, double-blind, multi-center study evaluating the safety and preliminary effectiveness of the Gen0Bh Transcranial Focused Ultrasound System for the treatment of motor symptoms in individuals with idiopathic Parkinson's disease.
详细描述
Participants will be randomized in a 1:1 allocation to receive either active or sham stimulation. Both participants and outcome assessors will remain blinded to treatment assignment. The study consists of 20 treatment sessions administered over approximately 4-6 weeks, followed by longitudinal follow-up through 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 22 to 80 years.
- •Diagnosis of idiopathic Parkinson's disease.
- •MDS-UPDRS Part III score ≥25 in OFF-medication state at baseline.
- •Stable dopaminergic therapy for at least 30 days prior to enrollment.
- •English proficiency.
- •Normal or corrective hearing and vision.
- •Ability to provide informed consent (or availability of an LAR) and comply with protocol requirements.
排除标准
- •Atypical or secondary Parkinsonism.
- •Prior deep brain stimulation or intracranial surgery.
- •MoCA score <
- •Severe psychiatric illness (e.g., psychosis, suicidality, untreated major depression).
- •History of seizure or intracranial pathology.
- •Significant neurologic disease (e.g. brain tumor, multiple sclerosis)
- •Contraindication to MRI or ultrasound.
- •Unstable systemic medical conditions.
- •Active malignancy or history of cancer within the past 5 years.
- •Pregnancy or breastfeeding.
- •Participation in another interventional trial.
研究组 & 干预措施
Active Transcranial Focused Ultrasound
Participants receive active transcranial focused ultrasound neuromodulation targeting the bilateral pallidum. Treatment consists of 20 sessions administered over approximately 4 to 6 weeks. Each session includes bilateral stimulation (15 minutes per hemisphere; 30 minutes total per session). Device parameters are configured to deliver therapeutic ultrasound energy per protocol specifications.
干预措施: Gen0Bh Transcranial Focused Ultrasound System (Active) (Device)
Sham Transcranial Focused Ultrasound
Participants undergo procedures identical to the active arm, including device setup, session duration, and visit schedule; however, no therapeutic ultrasound energy is delivered or energy is delivered at sub-therapeutic levels insufficient to produce neuromodulatory effects. This arm is designed to maintain participant and assessor blinding.
干预措施: Gen0Bh Transcranial Focused Ultrasound System (Sham) (Device)
结局指标
主要结局
Finger Tapping
时间窗: 2 weeks
A simple motor assessment used to measure speed, rhythm, and coordination of repetitive finger movements.
10-meter Timed Walk
时间窗: 2 weeks
A simple gait assessment in which a person is asked to walk 10 meters at a comfortable or maximum pace while the time taken is recorded. The test provides objective measures of walking speed and mobility.
Archimedes Spiral Test
时间窗: 2 weeks
A motor assessment in which a person is asked to draw a spiral on paper or a touchscreen. The accuracy, smoothness, and steadiness of the drawing provide a measure of tremor severity, fine motor control, and coordination.
PDQ-39
时间窗: 2 weeks
The Parkinson's Disease Questionnaire-39 (PDQ-39) is a standardized self-report measure of health-related quality of life in people with Parkinson's disease. It includes 39 questions across eight domains-such as mobility, daily living, emotional well-being, stigma, and social support-providing a comprehensive view of how the condition impacts everyday life.
GAD-7
时间窗: 2 weeks
The Generalized Anxiety Disorder 7-item (GAD-7) scale is a brief self-report questionnaire used to screen for and assess the severity of anxiety symptoms. It is widely applied in both clinical practice and research to monitor treatment outcomes and track changes over time.
Beck Depression Inventory
时间窗: 2 weeks
The Beck Depression Inventory is a widely used self-report questionnaire that measures the presence and severity of depressive symptoms. It includes a series of multiple-choice items covering mood, cognitive patterns, and physical symptoms, making it useful for both clinical assessment and research.
次要结局
- PDQ-39(1 month)
- Finger Tapping(1 month)
- 10-meter timed walk test(1 month)
- Archimedes Spiral Test(1 month)
- GAD-7(1 month)
- Beck Depression Inventory(1 month)