ADEPT DBS
Research type
Research Study
Full title
A multi-centre, prospective study 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.
IRAS ID
311721
Contact name
Tom Foltynie
Contact email
Sponsor organisation
The Bionics Institute of Australia
Clinicaltrials.gov Identifier
ACTRN12621001323819, ANZCTR trial registry: ; U1111-1268-5579, Universal Trial Number:
Duration of Study in the UK
2 years, 5 months, 31 days
Research summary
Summary of Research
Deep Brain Stimulation (DBS) is a type of treatment that can improve the symptoms and quality of life of people with Parkinson’s disease (PD). During DBS surgery, a thin metal wire (lead) that contains a number of electrodes is implanted into the brain. After surgery, the doctor ‘programs’ the DBS system to determine the best settings for each patient. In particular, the doctor needs to determine which electrodes on the lead should be chosen to deliver DBS. How well someone responds to DBS is heavily dependent on how accurately the DBS lead is placed in the brain and the location the doctor selects to deliver DBS.
The study ADEPT DBS investigates a new electrical signal, evoked resonant neural activity (ERNA), which is recorded from the DBS leads in the brain during surgery. The study aims to assess whether ERNA can be safely and reliably recorded from the DBS leads of people with PD. The study also investigates information on where to place the DBS lead during surgery and which electrodes to select to deliver DBS. Participants enrolled in the study will be required to attend three to five study visits to record baseline data, collect questionnaires and assess the symptoms of PD. The study visits will take place over a 16-month period, from prior to the DBS surgery, to 12 months after surgery.
People with PD who are planning to have DBS surgery as part of their usual clinical care at the National Hospital for Neurology and Neurosurgery (London) and John Radcliffe Hospital (Oxford) will be eligible to participate in the study.
The study is sponsored by the Bionics Institute of Australia, a not-for-profit medical research institute in Melbourne, Australia. In the United Kingdom, we aim to recruit a minimum of 30 participants across the two hospitals over 3 years.Summary of Results
This study enrolled eligible participants in Australia and the UK, with a total of 106 participants with Parkinson’s disease completing the study (29 in the UK). Each participant was implanted with a deep brain stimulation (DBS) system, comprising of two leads, in the left and right brain, with 8 electrodes on each lead. We examined participant’s medical imaging to determine how close each electrode on the DBS lead was to the subthalamic nucleus (STN) - a part of the brain considered to be a good target for DBS. We also measured a brain single termed Evoked Resonant Neural Activity (ERNA) which can be recorded from the DBS leads implanted in the STN. The ERNA signal could assist in identifying the best location to place the DBS leads in the STN and the best location to deliver the stimulation. In this study, we examined whether the ERNA signal was present in our recordings and how large the signal was.
We were able to record the ERNA signal in 99.55% of instances. We found that the ERNA signal varied across the 8 electrodes on the DBS lead. The ERNA signal was largest on electrodes that were very near to the subthalamic nucleus and was smaller for electrodes that were further away. These findings are important to validate that the ERNA signal can be reliably recorded, and that the size of the ERNA signal can give an indication of how close the electrode is to the ideal DBS target, the subthalamic nucleus.
We also examined which electrode the clinicians chose to program DBS in each participant. Although the clinicians performed programming without referring to the ERNA signal, there was good correspondence between clinical programming and the location on the DBS lead where the ERNA signal was strongest. This suggests that the ERNA signal could provide guidance on how to program DBS after surgery.REC name
West of Scotland REC 4
REC reference
22/WS/0095
Date of REC Opinion
18 Aug 2022
REC opinion
Further Information Favourable Opinion