Simpler and Safer Deep Brain Stimulation for Parkinson's Disease
- Conditions
- Parkinson's Disease
- Interventions
- Device: Bioinduction "Picostim" Deep Brain Stimulation system
- Registration Number
- NCT03837314
- Lead Sponsor
- North Bristol NHS Trust
- Brief Summary
The aim is to improve availability and acceptability of deep brain stimulation (DBS) for the treatment of Parkinson by shortening and simplifying the implantation procedure, thereby reducing time in surgery, complexity, post-surgery complications and cost, and increasing patient satisfaction.
To facilitate the shortening and simplifying of the implantation procedure, a miniaturised skull-mounted DBS device (Picostim) has been developed which is optimised to generate waveforms needed for stimulation of the subthalamic nucleus (STN) and STN region, employing a unique method of controlling stimulation current. The planned study is a single centre, open label, non-randomised design with the primary objective of showing similarity in control of motor symptoms for the Picostim device compared with previously published data for existing DBS devices.
- Detailed Description
High-frequency DBS of the STN and STN region is an established treatment for moderate to advanced Parkinson with motor fluctuations, reducing motor symptoms in late stage levodopa responsive patients, who are not adequately controlled by optimal medical therapy alone. However, DBS is presently employed in less than 2% of Parkinson patients. Although a proportion of Parkinson patients are for various reasons not suitable for DBS, currently there is a significant under-utilisation of this approach and in part this is due to perceived surgical risk. Other limitations to adoption are availability of surgeons and infrastructure, particularly outside the USA, and expense.
The objective of this project is to collect and assess safety data for a new DBS device for treatment of Parkinson and validate a new surgical technique employing a skull mounted device. The device, called Picostim, is highly miniaturised and optimised for Parkinson, with current controlled outputs and a rechargeable battery. In typical use, an inductive recharge is required once per week for one hour and service-life is projected to be 17 years. This project aims to advance the technology of DBS so that it is possible to treat a greater proportion of patients more easily, by shortening and simplifying procedures thereby reducing surgical time, complexity and cost, while increasing patient satisfaction and quality of life. Up to 25 patients will receive the Picostim implantation and will be followed up over a one-year period.
This pilot study will be sufficient to make an application for a CE mark in Europe and should inform future studies that are envisaged to be required to prepare an FDA pre-market application.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Deep Brain Stimulation Bioinduction "Picostim" Deep Brain Stimulation system Deep Brain stimulation using a novel device. Bioinduction "Picostim" Deep Brain Stimulation system
- Primary Outcome Measures
Name Time Method Change in motor function. 26 weeks Change in the Unified Parkinson's Disease Rating Scale (UPDRS) III score at 26 weeks post implantation with stimulation on without medication compared with baseline assessment (without medication). Standard range is from 0 to 108, lower score is better than higher score
Collection and recording of adverse events 26 weeks Rate and type of adverse events including serious adverse events, procedure-related, device-related, stimulation-related, and other adverse events
- Secondary Outcome Measures
Name Time Method Motor functions assessed through recording of motor fluctuation diary 12, 26 and 52 weeks post device implantation. Assessment of change from baseline in motor fluctuation diary recordings at 12, 26 and 52 weeks post implantation.
Mentation, Behaviour and Mood assessed through standard UPDRS Test (see description) 12, 26 and 52 weeks post device implantation. Assessment of change from baseline in motor functions: Unified Parkinson's Disease Rating Scale (UPDRS) I score at 12, 26 and 52 weeks post implantation. UPDRS I score can vary between 0 and 16, 16 being the worst outcome and 0 the best outcome
Post-operation complications: % of patients with infections and pain at the implantation site 12 weeks % of patients with infections and pain at the implantation site
Motor and cognitive functions assessed through standard Hoehn and Yahr test (see description) 12, 26 and 52 weeks post device implantation. Assessment of change from baseline in Hoehn and Yahr scores at 12, 26 and 52 weeks post implantation. Scale is between 1 to 5, best outcome being 1, worst outcome being 5
Surgical time to complete procedure 12, 26 and 52 weeks intra-operative post device implantation. Surgical time to complete procedure. Range being between 2h and 2 days.
Motor examinations assessed through standard UPDRS Test (see description) 12, 26 and 52 weeks post device implantation. Assessment of change from baseline in motor functions: Unified Parkinson's Disease Rating Scale (UPDRS) III score on medications at 12, 26 and 52 weeks post implantation. Scores range from 0 (best outcome) to 56 (worst outcome)
Quality of life assessed through standard Eq5D questionnaire (see description) 12, 26 and 52 weeks post device implantation. Assessment of change from baseline in quality of life measures at 12, 26 and 52 weeks post implantation. EuroQuality of Life score (Eq5D) score ranging from 5 to 15, 5 being the best outcome, 15 the worst.
Tolerability and satisfaction with the head mounted device on a 1-10 range Patient satisfaction questionnaire 12, 26 and 52 weeks post device implantation. User assessment of the tolerability of the head mounted device and of the device's battery efficiency (length and frequency of charging, ease of use) for up to one year following surgery. Assessed through a 1-10 scale, 1 being the worst outcome, 10 the best outcome
Motor and cognitive functions 12, 26 and 52 weeks post device implantation. Assessment of change from baseline in L-dopa equivalent. Medication requirements at 12, 26 and 52 weeks post implantation. Range between 300 mg/day and 2000 mg/day, best outcome is lower consumption (300 mg/day)
Cognitive functions assessed through standard Beck Depression Inventory Test (see description) 12, 26 and 52 weeks post device implantation. Assessment of change from baseline in cognitive function and mood status scores at 12, 26 and 52 weeks post implantation. Beck Depression Inventory score, range from 0 to 63, 0 being the best outcome, 63 being the worst outcome
Activities in Daily Living assessed through standard UPDRS Test (see description) 12, 26 and 52 weeks post device implantation. Assessment of change from baseline in motor functions: Unified Parkinson's Disease Rating Scale (UPDRS) II on and off stimulation at 12, 26 and 52 weeks post implantation. Scores range from 0 to 52, 0 being the best outcome, 52 the worst outcome
Complications of Therapy assessed through standard UPDRS Test (see description) 12, 26 and 52 weeks post device implantation. Assessment of change from baseline in motor functions: (Unified Parkinson's Disease Rating Scale) UPDRS IV score at 12, 26 and 52 weeks post implantation. Score range from 0 (best outcome) to 23 (worst outcome)
Safety data assessed through analysis of adverse events occurence 12, 26 and 52 weeks post device implantation. Collection and assessment of adverse events (procedure-related, device-related, stimulation-related, and other adverse events) throughout the trial. % of patients having device-related or procedure related adverse events.
Non-Motor functions assessed through standard Dementia Rating Scale (see description) 12, 26 and 52 weeks post device implantation. Assessment of change from baseline in non-motor symptom scores at 12, 26 and 52 weeks post implantation. Dementia Rating scale 2 (DRS-2) score. Range from 0 to 144, 144 being the best outcome.
Trial Locations
- Locations (1)
Bristol Brain Centre, Elgar House, Southmead Hospital
š¬š§Bristol, United Kingdom