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临床试验/NCT06932185
NCT06932185Enrolling By Invitation不适用

Transcranial Ultrasound to Disrupt Pathological Oscillations in the Brain of People With Parkinson's Disease and Other Neurological Disorders

University of Oxford1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年2月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
30
试验地点
1
主要终点
LFP modulation

研究概览

简要总结

Scientists and clinicians are interested in measuring and perturbing the signals in the brain - both to better understand normal operation and explore new therapy options for disease. One example of a signal is a "brainwave," also called a neural oscillation, which is a periodic oscillation of the electrical signals in the brain and which are linked to both normal and abnormal brain function.

When circuits in the brain are not working properly, investigators can see changes in the characteristics of these oscillations. Many neurological conditions produce changes in brainwaves. For example, in patients with Parkinson's disease, oscillations in the "beta band" (approximately 15Hz) are observed to be more prominent. In another example, investigators see similar large oscillations in the presence of a seizure in people with epilepsy. Disrupting these abnormal oscillations can treat some of the symptoms of disease. One example of this is found in Parkinson's disease, where surgeons can implant electrodes deep in the brain and electrically stimulate cells by a process called deep brain stimulation (DBS). With DBS, it is possible to suppress these beta oscillations and improve symptoms. However, DBS is a highly invasive procedure that includes the need for a burr hole in the skull, placement of the electrode in the brain, and insertion of a "pacemaker" in the chest with wires tunnelled through the neck. The investigators propose to use ultrasound to modify pathological brainwaves non-invasively.

While the proof-of-concept is in Parkinson's disease, the potential impact is much broader - if successful, the investigators will provide a non-invasive paradigm for probing the brain and exploring novel treatments for neurological conditions, such as pain and cognitive disorders.

详细描述

Transcranial Ultrasound Stimulation (TUS):

TUS will be applied using a commercially available transcranial ultrasound transducer and neuronavigation system that allows for targeting of specific brain regions. TUS targeting will be based on participant specific MRI and CT scans that take place as part of routine pre-operative planning before DBS implantation. TUS will then be applied during cognitive and motor tasks as described below.

Clinical assessments:

During each step of the study visit, during TUS to each target, clinical assessments will be made for each participant. These will be specific to the disease of interest and will be completed by a clinician. They will be filmed so that they can be assessed by blinded assessors after the study visit and allow for blinded quantification of TUS on clinical symptoms. A member of the research team will film assessments whilst a clinician completes them, and they will later scramble the video files to allow blinded assessment at a later date.

Cognitive tasks include a dot direction discrimination task and for pain participants will include quantitative sensory testing. Motor tasks will include a stop signal task.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Participant is willing and able to give informed consent for participation in the study.
  • •Male or Female, aged 18 years or above.
  • •Implanted Medtronic Percept or equivalent DBS system (one that can measure LFPs) or externalised depth electrodes as part of routine care
  • •Participant willing and able to tolerate transcranial ultrasound stimulation.
  • •Stable therapy with no drug changes in past 6 weeks
  • •Measurable beta peak on screening

排除标准

  • •Patients with extreme language barrier that cannot understand the purpose or instructions of the study despite the use of an interpreter.
  • •Patients with implanted electrodes without telemetric capacity.
  • •Co-morbid neurological disorder that may confound results, e.g. second motor impairment.
  • •Fever at time of study visit (>38 degrees Celsius)

研究组 & 干预措施

TUS Active Control

Active Comparator

干预措施: Transcranial Focussed Ultrasound - Active control (Other)

TUS active

Experimental

干预措施: Transcranial Focussed Ultrasound - Active (Other)

TUS sham

Sham Comparator

干预措施: Transcranial Focussed Ultrasound - Sham (Other)

结局指标

主要结局

LFP modulation

时间窗: Change from baseline during ultrasound

Electrical activity recorded from indwelling Deep Brain Stimulation electrodes

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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