Simpler and Safer Deep Brain Stimulation for Parkinson's Disease

Simpler and Safer Deep Brain Stimulation for Parkinson's Disease

Sponsors

Lead sponsor: North Bristol NHS Trust

Collaborator: Bioinduction

Source 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.

Overall Status Not yet recruiting
Start Date December 1, 2019
Completion Date February 1, 2023
Primary Completion Date February 1, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in motor function. 26 weeks
Collection and recording of adverse events 26 weeks
Secondary Outcome
Measure Time Frame
Surgical time to complete procedure 12, 26 and 52 weeks intra-operative post device implantation.
Post-operation complications: % of patients with infections and pain at the implantation site 12 weeks
Tolerability and satisfaction with the head mounted device on a 1-10 range Patient satisfaction questionnaire 12, 26 and 52 weeks post device implantation.
Motor functions assessed through recording of motor fluctuation diary 12, 26 and 52 weeks post device implantation.
Mentation, Behaviour and Mood assessed through standard UPDRS Test (see description) 12, 26 and 52 weeks post device implantation.
Motor and cognitive functions 12, 26 and 52 weeks post device implantation.
Motor and cognitive functions assessed through standard Hoehn and Yahr test (see description) 12, 26 and 52 weeks post device implantation.
Non-Motor functions assessed through standard Dementia Rating Scale (see description) 12, 26 and 52 weeks post device implantation.
Cognitive functions assessed through standard Beck Depression Inventory Test (see description) 12, 26 and 52 weeks post device implantation.
Quality of life assessed through standard Eq5D questionnaire (see description) 12, 26 and 52 weeks post device implantation.
Activities in Daily Living assessed through standard UPDRS Test (see description) 12, 26 and 52 weeks post device implantation.
Motor examinations assessed through standard UPDRS Test (see description) 12, 26 and 52 weeks post device implantation.
Complications of Therapy assessed through standard UPDRS Test (see description) 12, 26 and 52 weeks post device implantation.
Safety data assessed through analysis of adverse events occurence 12, 26 and 52 weeks post device implantation.
Enrollment 25
Condition
Intervention

Intervention type: Device

Intervention name: Bioinduction "Picostim" Deep Brain Stimulation system

Description: Neurostimulation of the subthalamic nucleus region.

Arm group label: Deep Brain Stimulation

Eligibility

Criteria:

Inclusion criteria:

- Patients who report motor symptoms of Parkinson for at least 4 years;

- Patients eligible for DBS Surgery;

- Receiving stable medical therapy for 30 days or longer before screening assessments - as reported by the patient;

- Males and females aged 21 years or older;

- Be willing and able to comply with all visits and study related procedures (e.g., using the remote control, charging systems and completing the motor diary);

- Understands the study requirements and the treatment procedures and is able to provide written informed consent;

- Females of child-bearing potential must have a negative pregnancy test at study entry and report using an effective method of contraception;

Exclusion criteria:

- Atypical Parkinsonian (Parkinson-plus) syndromes;

- Any prior movement disorder treatments that involved intracranial surgery or device implantation;

- Presence of or planned implant of any other active implanted device;

- Surgical contraindications (such as issues preventing safe anaesthesia);

- Contraindications for MRI scanning (such as presence of metal in the body which means scanning may be harmful);

- Active alcohol or drug abuse;

- Dementia or any neuropsychological condition or finding that would contraindicate DBS surgery. Mattis DRS-2 AEMSS of 6 or less;

- Previous brain surgery likely to interfere with DBS implant;

- Frequent falls when on adequate medication therapy in an "on" state, in the opinion of the PI/delegated clinician;

- A past or current psychiatric disturbance that in the opinion of the PI contraindicates DBS surgery;

- Use of anticoagulant medications that cannot be discontinued during perioperative period;

- Clinically problematic dopamine dysregulation syndrome in the opinion of the PI;

- Significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with expected survival of less than 5 years;

- Participation in another trial concurrently or within 30 days preceding enrolment, that is deemed to interfere with this trial;

- Females who are pregnant, considering becoming pregnant during the study period, or who are breastfeeding.

Gender: All

Minimum age: 21 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Overall Contact

Last name: Tara Noone

Phone: 0117 987 4110

Email: [email protected]

Verification Date

February 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Deep Brain Stimulation

Arm group type: Experimental

Description: Deep Brain stimulation using a novel device. Bioinduction "Picostim" Deep Brain Stimulation system

Acronym SPARKS
Patient Data No
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov