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Simpler and Safer Deep Brain Stimulation for Parkinson's Disease (SPARKS)

Primary Purpose

Parkinson's Disease

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Bioinduction "Picostim" Deep Brain Stimulation system
Sponsored by
North Bristol NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Deep Brain Stimulation, Neuromodulation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bristol Brain Centre, Elgar House, Southmead Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Deep Brain Stimulation

Arm Description

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

Outcomes

Primary Outcome Measures

Change in motor function.
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
Rate and type of adverse events including serious adverse events, procedure-related, device-related, stimulation-related, and other adverse events

Secondary Outcome Measures

Surgical time to complete procedure
Surgical time to complete procedure. Range being between 2h and 2 days.
Post-operation complications: % of patients with infections and pain at the implantation site
% of patients with infections and pain at the implantation site
Tolerability and satisfaction with the head mounted device on a 1-10 range Patient satisfaction questionnaire
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 functions assessed through recording of motor fluctuation diary
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)
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
Motor and cognitive functions
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)
Motor and cognitive functions assessed through standard Hoehn and Yahr test (see description)
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
Non-Motor functions assessed through standard Dementia Rating Scale (see description)
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.
Cognitive functions assessed through standard Beck Depression Inventory Test (see description)
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
Quality of life assessed through standard Eq5D questionnaire (see description)
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.
Activities in Daily Living assessed through standard UPDRS Test (see description)
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
Motor examinations assessed through standard UPDRS Test (see description)
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)
Complications of Therapy assessed through standard UPDRS Test (see description)
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
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.

Full Information

First Posted
April 16, 2015
Last Updated
December 15, 2021
Sponsor
North Bristol NHS Trust
Collaborators
Bioinduction
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1. Study Identification

Unique Protocol Identification Number
NCT03837314
Brief Title
Simpler and Safer Deep Brain Stimulation for Parkinson's Disease
Acronym
SPARKS
Official Title
Simpler and Safer Deep Brain Stimulation for Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 28, 2020 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
North Bristol NHS Trust
Collaborators
Bioinduction

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Deep Brain Stimulation, Neuromodulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Deep Brain Stimulation
Arm Type
Experimental
Arm Description
Deep Brain stimulation using a novel device. Bioinduction "Picostim" Deep Brain Stimulation system
Intervention Type
Device
Intervention Name(s)
Bioinduction "Picostim" Deep Brain Stimulation system
Intervention Description
Neurostimulation of the subthalamic nucleus region.
Primary Outcome Measure Information:
Title
Change in motor function.
Description
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
Time Frame
26 weeks
Title
Collection and recording of adverse events
Description
Rate and type of adverse events including serious adverse events, procedure-related, device-related, stimulation-related, and other adverse events
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Surgical time to complete procedure
Description
Surgical time to complete procedure. Range being between 2h and 2 days.
Time Frame
12, 26 and 52 weeks intra-operative post device implantation.
Title
Post-operation complications: % of patients with infections and pain at the implantation site
Description
% of patients with infections and pain at the implantation site
Time Frame
12 weeks
Title
Tolerability and satisfaction with the head mounted device on a 1-10 range Patient satisfaction questionnaire
Description
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
Time Frame
12, 26 and 52 weeks post device implantation.
Title
Motor functions assessed through recording of motor fluctuation diary
Description
Assessment of change from baseline in motor fluctuation diary recordings at 12, 26 and 52 weeks post implantation.
Time Frame
12, 26 and 52 weeks post device implantation.
Title
Mentation, Behaviour and Mood assessed through standard UPDRS Test (see description)
Description
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
Time Frame
12, 26 and 52 weeks post device implantation.
Title
Motor and cognitive functions
Description
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)
Time Frame
12, 26 and 52 weeks post device implantation.
Title
Motor and cognitive functions assessed through standard Hoehn and Yahr test (see description)
Description
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
Time Frame
12, 26 and 52 weeks post device implantation.
Title
Non-Motor functions assessed through standard Dementia Rating Scale (see description)
Description
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.
Time Frame
12, 26 and 52 weeks post device implantation.
Title
Cognitive functions assessed through standard Beck Depression Inventory Test (see description)
Description
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
Time Frame
12, 26 and 52 weeks post device implantation.
Title
Quality of life assessed through standard Eq5D questionnaire (see description)
Description
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.
Time Frame
12, 26 and 52 weeks post device implantation.
Title
Activities in Daily Living assessed through standard UPDRS Test (see description)
Description
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
Time Frame
12, 26 and 52 weeks post device implantation.
Title
Motor examinations assessed through standard UPDRS Test (see description)
Description
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)
Time Frame
12, 26 and 52 weeks post device implantation.
Title
Complications of Therapy assessed through standard UPDRS Test (see description)
Description
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)
Time Frame
12, 26 and 52 weeks post device implantation.
Title
Safety data assessed through analysis of adverse events occurence
Description
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.
Time Frame
12, 26 and 52 weeks post device implantation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Whone, PhD
Organizational Affiliation
North Bristol NHS Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nik Patel, MD
Organizational Affiliation
North Bristol NHS Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steve Gill, MD
Organizational Affiliation
North Bristol NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bristol Brain Centre, Elgar House, Southmead Hospital
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.nbt.nhs.uk/our-services/a-z-services/functional-neurosurgery
Description
Study site and Sponsor
URL
http://www.bioinduction.com/
Description
Study funder

Learn more about this trial

Simpler and Safer Deep Brain Stimulation for Parkinson's Disease

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