Trial ID: ISRCTN15101017
Other - Phase Unknown - No longer available
Background and study aims Subthalamic nucleus (STN) beta-triggered adaptive deep brain stimulation (ADBS) has been shown to provide clinical improvement compared to conventional continuous DBS (CDBS) with less energy delivered to the brain and fewer stimulation-induced side effects. However, several questions remain unanswered. First, there is a normal physiological reduction of STN beta band power just prior to and during voluntary movement. ADBS systems will therefore reduce or cease stimulation during movement in people with Parkinson’s disease (PD) and could therefore compromise motor performance compared to CDBS. Second, beta power was smoothed and estimated over a time period of 400 ms in most previous ADBS studies, but a shorter smoothing period could have the advantage of being more sensitive to changes in beta power which could enhance motor performance. In this study, we addressed these two questions by evaluating the effectiveness of STN beta-triggered ADBS using a standard 400 ms and a shorter 200 ms smoothing window during reaching movements. Who can participate? Patients aged 18 or older with PD with DBS electrodes implanted What does the study involve? This study will take place between Stage 1 and Stage 2 of your operation. If you are taking medication for PD you will be asked if you mind omitting this on the day of the study. The study can go ahead regardless, but our results might be slightly easier to interpret should you omit your medication. Should you omit your medication you can restart it the same day after the recordings. We then tape some small electrodes and a motion-sensitive device to the skin overlying some muscles of the most affected body regions. The electrodes pick up the electrical activity from the muscles, while the device picks up physical movement. We also use a paste to place some small electrodes on your scalp and connect them to the deep brain electrodes. These record superficial and deep brain waves, respectively. You will be asked to perform two tasks, including a reaching task performed on a Tablet Drawing Monitor with a stylus pen, and a 20s finger-tapping task. We will record a video for each of the 20-sec finger-tapping movements for later analysis. The video will only capture the tapping hand. During the task, we will test several different protocols for stimulating the deep brain electrodes. We use exactly the same parameters of stimulation that are used clinically and start by gently increasing the stimulation intensity until you begin to experience reversible side effects. We can then use a stimulation intensity that is just below this level during the rest of the study. The whole test would take up to two hours to complete. Once we have finished, we will remove all the electrodes. That is the end of that study day, and you are then free to take your medication should you have opted to withhold it during the study. What are the possible benefits and risks of participating? Involvement in the study will not affect the clinical care you receive. The research assessments and recordings that will be performed during the study are neither invasive nor harmful. The researchers do not expect harm from participating, but there is a small risk that stimulation will cause temporary tingling, cramping or slurring of speech. Should you omit your medication for PD for the study (not obligatory in this study) then this will only be for the morning of the study. As such you may only experience a temporary and reversible exacerbation of your symptoms, similar to forgetting a dose. The recording session may last up to two hours. All but one of the medical devices we are using in the assessments are CE-marked. The stimulator is not CE-marked and is built at the University of Oxford. It passes all of the required safety tests and is an updated version of a similar custom-built stimulator successfully and safely used in other studies. Where is the study run from? University of Oxford (UK) When is the study starting and how long is it expected to run for? July 2020 to December 2024 Who is funding the study? Medical Research Council (UK) Who is the main contact? 1. Dr Shenghong He, shenghong.he@ndcn.ox.ac.uk 2. Prof Huiling Tan, huiling.tan@ndcn.ox.ac.uk
University of Oxford
Source: https://www.isrctn.com/