Skip to content

Identifying the ideal location for Deep Brain Stimulation (DBS) in the Treatment of Parkinson's Disease.

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.

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001323819
Acronym
ADEPT DBS (Assisted Determination of Electrode Positioning and Therapy for Deep Brain Stimulation)
Enrollment
91
Registered
2021-09-29
Start date
2021-10-11
Completion date
2024-06-18
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Deep brain stimulation (DBS) is an established treatment for Parkinson’s disease (PD) and has been shown to improve the symptoms and quality of life of patients with this condition. The effectiveness of DBS relies on applying DBS therapy to an ‘ideal’ location to achieve maximal symptom improvement. This ‘ideal’ location is dependent on where the DBS lead is implanted during surgery and where the doctor choses to apply DBS therapy along the lead after surgery. Electrical signals recorded in the brain during DBS surgery may help doctors in identifying: 1) the ‘ideal’ location to implant DBS leads during surgery and 2) the ‘ideal’ location to apply DBS therapy after surgery. Evoked resonant neural activity (ERNA) is a new electrical brain signal that has been recorded from DBS leads during surgery in patients with PD. ERNA holds significant promise as an electrical brain signal that could guide DBS lead implantation during surgery and assist doctors in selecting the ‘ideal’ location to apply DBS. However, the reliability of recording ERNA signals in the brains of patients with PD is unknown. Therefore, the primary purpose of this study is the establish whether the ERNA signal can be reliably and safely recorded in the brains of patients with PD during DBS surgery. The secondary purpose of this study is to determine how the ERNA signal relates to the location of the DBS leads in the brain and the response of the patient to DBS therapy.

Interventions

All participants undergoing DBS for Parkinson’s disease will have bioelectric signals (including ERNA) recorded during surgery at the time of DBS lead implantation. The bioelectric signals will be measured using the Bionics Institute customised neurostimulator and recording system (ADEPT). The customised device will be operated by a highly trained researcher from the Bionics Institute. The collection of this bioelectric signal data will occur during the DBS surgery and take approximately 15-20 m

All participants undergoing DBS for Parkinson’s disease will have bioelectric signals (including ERNA) recorded during surgery at the time of DBS lead implantation. The bioelectric signals will be measured using the Bionics Institute customised neurostimulator and recording system (ADEPT). The customised device will be operated by a highly trained researcher from the Bionics Institute. The collection of this bioelectric signal data will occur during the DBS surgery and take approximately 15-20 minutes. The surgeon will not be blinded to the ERNA signal data intra-operatively. However, this ERNA signal data will not be used to guide electrode placement. Except for the recording of bioelectric signals using the ADEPT device, the DBS implantation surgery will proceed as per standard of care. The DBS procedure may vary according to the preferences of the treating team. The final DBS lead location will be determined as per standard of care using a combination of brain imaging guided stereotactic surgery +/- intra-operative clinical evaluation +/- brain microelectrode recordings on a commercially available recording device. The total duration of surgery varies between treating teams, though it is routinely 3 – 5 hours. All participants will have standard of care brain imaging (MRI brain, CT brain) prior to and after surgery, to identify the location of the DBS electrodes implanted into the brain. All participants will also have an additional (non-standard of care) cranial x-ray within 2 weeks of the first post-operative study visit, 4 months after surgery. The DBS electrodes (standard of care) implanted during surgery have directionality to enable steering of stimulation in a certain direction. This cranial x-ray is required to confirm the directionality of the DBS leads relative to the adjacent anatomical structures. This will enable ERNA signals recorded on each electrode to be accurately referenced to the anatomical location of the electrode. All participants will have a baseline visit prior to DBS surgery and follow-up study visits at 4 months and 12 months after surgery. At these visits, observational data including motor scores, questionnaires (to measure motor, cognitive and neuropsychiatric outcomes) and the medications and DBS parameters prescribed by the treating doctor will be collected. A subset of participants will attend an Acute Clinical Evaluation experimental session over two days, 4 months after DBS surgery. Participants for the Acute Clinical Evaluation study will need to meet the additional inclusion criteria of an upper limb rigidity score of equal or greater than 2 on the worse affected side, as rated by the Unified Parkinson’s Disease Rating Scale part III. General circumstances including a good post-operative recovery, geographical location and ease of access to sessions will be considered when selecting participants for this sub-study. During these sessions, the DBS will be adjusted temporarily by a movement disorders clinician with the resultant changes in motor symptoms measured. The participant's DBS parameters will be returned to those prescribed by the treating doctor at the end of the experimental session.

Sponsors

Bionics Institute
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026