Simpler and Safer Deep Brain Stimulation for Parkinson's Disease

NCT ID: NCT03837314

Last Updated: 2023-10-30

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-28
• Study Completion Date: 2026-01-01

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Deep Brain Stimulation

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

Group Type: EXPERIMENTAL

Bioinduction "Picostim" Deep Brain Stimulation system

Intervention Type: DEVICE

Neurostimulation of the subthalamic nucleus region.

Interventions

Bioinduction "Picostim" Deep Brain Stimulation system

Neurostimulation of the subthalamic nucleus region.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bioinduction

INDUSTRY

Sponsor Role: collaborator

North Bristol NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alan Whone, PhD

Role: PRINCIPAL_INVESTIGATOR

North Bristol NHS Trust

Nik Patel, MD

Role: PRINCIPAL_INVESTIGATOR

North Bristol NHS Trust

Steve Gill, MD

Role: PRINCIPAL_INVESTIGATOR

North Bristol NHS Trust

Locations

Bristol Brain Centre, Elgar House, Southmead Hospital

Bristol, , United Kingdom

Countries

United Kingdom

Related Links

http://www.nbt.nhs.uk/our-services/a-z-services/functional-neurosurgery

Study site and Sponsor

http://www.bioinduction.com/

Study funder

Other Identifiers

3174

Identifier Type: -

Identifier Source: org_study_id