<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03837314</url>
  </required_header>
  <id_info>
    <org_study_id>3174</org_study_id>
    <nct_id>NCT03837314</nct_id>
  </id_info>
  <brief_title>Simpler and Safer Deep Brain Stimulation for Parkinson's Disease</brief_title>
  <acronym>SPARKS</acronym>
  <official_title>Simpler and Safer Deep Brain Stimulation for Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>North Bristol NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bioinduction</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>North Bristol NHS Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim is to improve availability and acceptability of deep brain stimulation (DBS) for the&#xD;
      treatment of Parkinson by shortening and simplifying the implantation procedure, thereby&#xD;
      reducing time in surgery, complexity, post-surgery complications and cost, and increasing&#xD;
      patient satisfaction.&#xD;
&#xD;
      To facilitate the shortening and simplifying of the implantation procedure, a miniaturised&#xD;
      skull-mounted DBS device (Picostim) has been developed which is optimised to generate&#xD;
      waveforms needed for stimulation of the subthalamic nucleus (STN) and STN region, employing a&#xD;
      unique method of controlling stimulation current. The planned study is a single centre, open&#xD;
      label, non-randomised design with the primary objective of showing similarity in control of&#xD;
      motor symptoms for the Picostim device compared with previously published data for existing&#xD;
      DBS devices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      High-frequency DBS of the STN and STN region is an established treatment for moderate to&#xD;
      advanced Parkinson with motor fluctuations, reducing motor symptoms in late stage levodopa&#xD;
      responsive patients, who are not adequately controlled by optimal medical therapy alone.&#xD;
      However, DBS is presently employed in less than 2% of Parkinson patients. Although a&#xD;
      proportion of Parkinson patients are for various reasons not suitable for DBS, currently&#xD;
      there is a significant under-utilisation of this approach and in part this is due to&#xD;
      perceived surgical risk. Other limitations to adoption are availability of surgeons and&#xD;
      infrastructure, particularly outside the USA, and expense.&#xD;
&#xD;
      The objective of this project is to collect and assess safety data for a new DBS device for&#xD;
      treatment of Parkinson and validate a new surgical technique employing a skull mounted&#xD;
      device. The device, called Picostim, is highly miniaturised and optimised for Parkinson, with&#xD;
      current controlled outputs and a rechargeable battery. In typical use, an inductive recharge&#xD;
      is required once per week for one hour and service-life is projected to be 17 years. This&#xD;
      project aims to advance the technology of DBS so that it is possible to treat a greater&#xD;
      proportion of patients more easily, by shortening and simplifying procedures thereby reducing&#xD;
      surgical time, complexity and cost, while increasing patient satisfaction and quality of&#xD;
      life. Up to 25 patients will receive the Picostim implantation and will be followed up over a&#xD;
      one-year period.&#xD;
&#xD;
      This pilot study will be sufficient to make an application for a CE mark in Europe and should&#xD;
      inform future studies that are envisaged to be required to prepare an FDA pre-market&#xD;
      application.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">October 28, 2020</start_date>
  <completion_date type="Anticipated">January 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in motor function.</measure>
    <time_frame>26 weeks</time_frame>
    <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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Collection and recording of adverse events</measure>
    <time_frame>26 weeks</time_frame>
    <description>Rate and type of adverse events including serious adverse events, procedure-related, device-related, stimulation-related, and other adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surgical time to complete procedure</measure>
    <time_frame>12, 26 and 52 weeks intra-operative post device implantation.</time_frame>
    <description>Surgical time to complete procedure. Range being between 2h and 2 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operation complications: % of patients with infections and pain at the implantation site</measure>
    <time_frame>12 weeks</time_frame>
    <description>% of patients with infections and pain at the implantation site</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerability and satisfaction with the head mounted device on a 1-10 range Patient satisfaction questionnaire</measure>
    <time_frame>12, 26 and 52 weeks post device implantation.</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor functions assessed through recording of motor fluctuation diary</measure>
    <time_frame>12, 26 and 52 weeks post device implantation.</time_frame>
    <description>Assessment of change from baseline in motor fluctuation diary recordings at 12, 26 and 52 weeks post implantation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mentation, Behaviour and Mood assessed through standard UPDRS Test (see description)</measure>
    <time_frame>12, 26 and 52 weeks post device implantation.</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor and cognitive functions</measure>
    <time_frame>12, 26 and 52 weeks post device implantation.</time_frame>
    <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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor and cognitive functions assessed through standard Hoehn and Yahr test (see description)</measure>
    <time_frame>12, 26 and 52 weeks post device implantation.</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-Motor functions assessed through standard Dementia Rating Scale (see description)</measure>
    <time_frame>12, 26 and 52 weeks post device implantation.</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive functions assessed through standard Beck Depression Inventory Test (see description)</measure>
    <time_frame>12, 26 and 52 weeks post device implantation.</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessed through standard Eq5D questionnaire (see description)</measure>
    <time_frame>12, 26 and 52 weeks post device implantation.</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activities in Daily Living assessed through standard UPDRS Test (see description)</measure>
    <time_frame>12, 26 and 52 weeks post device implantation.</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor examinations assessed through standard UPDRS Test (see description)</measure>
    <time_frame>12, 26 and 52 weeks post device implantation.</time_frame>
    <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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications of Therapy assessed through standard UPDRS Test (see description)</measure>
    <time_frame>12, 26 and 52 weeks post device implantation.</time_frame>
    <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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety data assessed through analysis of adverse events occurence</measure>
    <time_frame>12, 26 and 52 weeks post device implantation.</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>Deep Brain Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Deep Brain stimulation using a novel device. Bioinduction &quot;Picostim&quot; Deep Brain Stimulation system</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bioinduction &quot;Picostim&quot; Deep Brain Stimulation system</intervention_name>
    <description>Neurostimulation of the subthalamic nucleus region.</description>
    <arm_group_label>Deep Brain Stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Patients who report motor symptoms of Parkinson for at least 4 years;&#xD;
&#xD;
          -  Patients eligible for DBS Surgery;&#xD;
&#xD;
          -  Receiving stable medical therapy for 30 days or longer before screening assessments -&#xD;
             as reported by the patient;&#xD;
&#xD;
          -  Males and females aged 21 years or older;&#xD;
&#xD;
          -  Be willing and able to comply with all visits and study related procedures (e.g.,&#xD;
             using the remote control, charging systems and completing the motor diary);&#xD;
&#xD;
          -  Understands the study requirements and the treatment procedures and is able to provide&#xD;
             written informed consent;&#xD;
&#xD;
          -  Females of child-bearing potential must have a negative pregnancy test at study entry&#xD;
             and report using an effective method of contraception;&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Atypical Parkinsonian (Parkinson-plus) syndromes;&#xD;
&#xD;
          -  Any prior movement disorder treatments that involved intracranial surgery or device&#xD;
             implantation;&#xD;
&#xD;
          -  Presence of or planned implant of any other active implanted device;&#xD;
&#xD;
          -  Surgical contraindications (such as issues preventing safe anaesthesia);&#xD;
&#xD;
          -  Contraindications for MRI scanning (such as presence of metal in the body which means&#xD;
             scanning may be harmful);&#xD;
&#xD;
          -  Active alcohol or drug abuse;&#xD;
&#xD;
          -  Dementia or any neuropsychological condition or finding that would contraindicate DBS&#xD;
             surgery. Mattis DRS-2 AEMSS of 6 or less;&#xD;
&#xD;
          -  Previous brain surgery likely to interfere with DBS implant;&#xD;
&#xD;
          -  Frequent falls when on adequate medication therapy in an &quot;on&quot; state, in the opinion of&#xD;
             the PI/delegated clinician;&#xD;
&#xD;
          -  A past or current psychiatric disturbance that in the opinion of the PI&#xD;
             contraindicates DBS surgery;&#xD;
&#xD;
          -  Use of anticoagulant medications that cannot be discontinued during perioperative&#xD;
             period;&#xD;
&#xD;
          -  Clinically problematic dopamine dysregulation syndrome in the opinion of the PI;&#xD;
&#xD;
          -  Significant medical condition that is likely to interfere with study procedures or&#xD;
             likely to confound evaluation of study endpoints, including any terminal illness with&#xD;
             expected survival of less than 5 years;&#xD;
&#xD;
          -  Participation in another trial concurrently or within 30 days preceding enrolment,&#xD;
             that is deemed to interfere with this trial;&#xD;
&#xD;
          -  Females who are pregnant, considering becoming pregnant during the study period, or&#xD;
             who are breastfeeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alan Whone, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>North Bristol NHS Trust</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nik Patel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>North Bristol NHS Trust</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Steve Gill, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>North Bristol NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bristol Brain Centre, Elgar House, Southmead Hospital</name>
      <address>
        <city>Bristol</city>
        <zip>BS10 5NB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://www.nbt.nhs.uk/our-services/a-z-services/functional-neurosurgery</url>
    <description>Study site and Sponsor</description>
  </link>
  <link>
    <url>http://www.bioinduction.com/</url>
    <description>Study funder</description>
  </link>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>April 16, 2015</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>December 15, 2021</last_update_submitted>
  <last_update_submitted_qc>December 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson's disease</keyword>
  <keyword>Deep Brain Stimulation</keyword>
  <keyword>Neuromodulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03837314
org study id: 3174
nct id: NCT03837314
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in motor function.
time frame: 26 weeks
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
measure: Collection and recording of adverse events
time frame: 26 weeks
description: Rate and type of adverse events including serious adverse events, procedure-related, device-related, stimulation-related, and other adverse events
measure: Surgical time to complete procedure
time frame: 12, 26 and 52 weeks intra-operative post device implantation.
description: Surgical time to complete procedure. Range being between 2h and 2 days.
measure: Post-operation complications: % of patients with infections and pain at the implantation site
time frame: 12 weeks
description: % of patients with infections and pain at the implantation site
measure: Tolerability and satisfaction with the head mounted device on a 1-10 range Patient satisfaction questionnaire
time frame: 12, 26 and 52 weeks post device implantation.
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
measure: Motor functions assessed through recording of motor fluctuation diary
time frame: 12, 26 and 52 weeks post device implantation.
description: Assessment of change from baseline in motor fluctuation diary recordings at 12, 26 and 52 weeks post implantation.
measure: Mentation, Behaviour and Mood assessed through standard UPDRS Test (see description)
time frame: 12, 26 and 52 weeks post device implantation.
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
measure: Motor and cognitive functions
time frame: 12, 26 and 52 weeks post device implantation.
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)
measure: Motor and cognitive functions assessed through standard Hoehn and Yahr test (see description)
time frame: 12, 26 and 52 weeks post device implantation.
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
measure: Non-Motor functions assessed through standard Dementia Rating Scale (see description)
time frame: 12, 26 and 52 weeks post device implantation.
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.
measure: Cognitive functions assessed through standard Beck Depression Inventory Test (see description)
time frame: 12, 26 and 52 weeks post device implantation.
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
measure: Quality of life assessed through standard Eq5D questionnaire (see description)
time frame: 12, 26 and 52 weeks post device implantation.
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.
measure: Activities in Daily Living assessed through standard UPDRS Test (see description)
time frame: 12, 26 and 52 weeks post device implantation.
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
measure: Motor examinations assessed through standard UPDRS Test (see description)
time frame: 12, 26 and 52 weeks post device implantation.
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)
measure: Complications of Therapy assessed through standard UPDRS Test (see description)
time frame: 12, 26 and 52 weeks post device implantation.
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)
measure: Safety data assessed through analysis of adverse events occurence
time frame: 12, 26 and 52 weeks post device implantation.
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.
arm group label: Deep Brain Stimulation
arm group type: Experimental
description: Deep Brain stimulation using a novel device. Bioinduction "Picostim" Deep Brain Stimulation system
intervention type: Device
intervention name: Bioinduction "Picostim" Deep Brain Stimulation system
description: Neurostimulation of the subthalamic nucleus region.
arm group label: Deep Brain Stimulation
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Alan Whone, PhD
role: Principal Investigator
affiliation: North Bristol NHS Trust
last name: Nik Patel, MD
role: Principal Investigator
affiliation: North Bristol NHS Trust
last name: Steve Gill, MD
role: Principal Investigator
affiliation: North Bristol NHS Trust
facility: 
country: United Kingdom
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
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: No