Clinical trial NCT03837314: Simpler and Safer Deep Brain Stimulation for Parkinson's Disease
Official title: Simpler and Safer Deep Brain Stimulation for Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Deep Brain Stimulation
Neuromodulation
Lead sponsor: North Bristol NHS Trust
Sponsor class: OTHER
Collaborators: name: Bioinduction
First posted: 2019-02-12
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in motor function.
timeFrame: 26 weeks
measure: Collection and recording of adverse events
timeFrame: 26 weeks
Secondary outcomes:
measure: Surgical time to complete procedure
timeFrame: 12, 26 and 52 weeks intra-operative post device implantation.
measure: Post-operation complications: % of patients with infections and pain at the implantation site
timeFrame: 12 weeks
measure: Tolerability and satisfaction with the head mounted device on a 1-10 range Patient satisfaction questionnaire
timeFrame: 12, 26 and 52 weeks post device implantation.
measure: Motor functions assessed through recording of motor fluctuation diary
timeFrame: 12, 26 and 52 weeks post device implantation.
measure: Mentation, Behaviour and Mood assessed through standard UPDRS Test (see description)
timeFrame: 12, 26 and 52 weeks post device implantation.
measure: Motor and cognitive functions
timeFrame: 12, 26 and 52 weeks post device implantation.
measure: Motor and cognitive functions assessed through standard Hoehn and Yahr test (see description)
timeFrame: 12, 26 and 52 weeks post device implantation.
measure: Non-Motor functions assessed through standard Dementia Rating Scale (see description)
timeFrame: 12, 26 and 52 weeks post device implantation.
measure: Cognitive functions assessed through standard Beck Depression Inventory Test (see description)
timeFrame: 12, 26 and 52 weeks post device implantation.
measure: Quality of life assessed through standard Eq5D questionnaire (see description)
timeFrame: 12, 26 and 52 weeks post device implantation.
measure: Activities in Daily Living assessed through standard UPDRS Test (see description)
timeFrame: 12, 26 and 52 weeks post device implantation.
measure: Motor examinations assessed through standard UPDRS Test (see description)
timeFrame: 12, 26 and 52 weeks post device implantation.
measure: Complications of Therapy assessed through standard UPDRS Test (see description)
timeFrame: 12, 26 and 52 weeks post device implantation.
measure: Safety data assessed through analysis of adverse events occurence
timeFrame: 12, 26 and 52 weeks post device implantation.
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Bristol Brain Centre, Elgar House, Southmead Hospital
Study officials:
affiliation: North Bristol NHS Trust
name: Alan Whone, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: North Bristol NHS Trust
name: Nik Patel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: North Bristol NHS Trust
name: Steve Gill, MD
role: PRINCIPAL_INVESTIGATOR
References: