A multi-centre, prospective trial exploring the use of neuronal signals to identify the ideal location to implant and apply Deep Brain Stimulation (DBS) in the Treatment of Parkinson’s Disease.

Bionics Institute0 个研究点目标入组 100 人开始时间: 2021年9月29日最近更新: 2021年10月11日

适应症

试验速览

暂无简介。

•Participants are eligible to be included in the study only if all the following criteria apply:
•Participants aged 18 years or older at the time of recruitment into the study.
•Participants who have been diagnosed with Parkinson’s disease by a neurologist.
•Participants who have planned to have deep brain stimulation surgery for treatment of Parkinson’s disease.
•A level of general anaesthesia optimised for neuronal signal recordings, at the discretion of the anaesthetist, at the time of data acquisition during deep brain stimulation surgery.
•Participants have a >40% improvement in UPDRS part III motor scores on medication compared to off medication.
•Participants who are capable of giving signed informed consent as described the Study Protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
•Participants who can complete regular study visits in accordance with the study protocol requirements.
•Participants are eligible for the Acute Clinical Evaluation sub-study if they satisfy:
•In the worse affected hemibody off medication, participants who have a minimum upper limb rigidity score of grade 2 on the Unified Parkinson's Disease Rating Scale part III motor scale

•Participants are excluded from the study if any of the following criteria apply:
•Participants who are non-fluent in the English language.
•Participants who are unable to give informed consent.
•Participants who are pregnant or breastfeeding.
•Participants who have a significant psychiatric, behavioural or any other issue which, in the opinion of the investigators, might significantly compromise their ability to understand or complete the study protocol.

发起方