xml: <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/NCT06005584</url>
    </required_header>
    <id_info>
      <org_study_id>22CX7894</org_study_id>
      <nct_id>NCT06005584</nct_id>
    </id_info>
    <brief_title>Spinal Cord Stimulation for Gait Dysfunction in Parkinson's Disease</brief_title>
    <acronym>SCORE-PD</acronym>
    <official_title>Spinal Cord Stimulation to Reduce Imbalance and Falls in Parkinson's Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Imperial College London</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Imperial College London</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Parkinson's disease (PD) is the second commonest neurodegenerative disorder, affecting over&#xD;
        145,000 people in the UK. Initially, PD patients experience slowness of movements, limb&#xD;
        stiffness, and tremor.&#xD;
  &#xD;
        With progressive loss of neurons over time, many patients start to experience balance and&#xD;
        walking problems, and falls, which are resistant to currently available treatments. Falls can&#xD;
        lead to fractures and nursing home admission, and can significantly shorten patients' life&#xD;
        expectancy.&#xD;
  &#xD;
        In this pilot study, the investigators will investigate the effects of spinal cord&#xD;
        stimulation (SCS) on gait and balance in PD. Some open-labelled studies have shown possible&#xD;
        beneficial effects of SCS in PD, although it is uncertain which type of PD patients will&#xD;
        benefit most and which stimulation parameters work best. The investigators will assess the&#xD;
        effects of SCS on posture and gait using a series of clinical, laboratory, imaging, and&#xD;
        wearable measurements.&#xD;
  &#xD;
        The participants will receive a percutaneous implantation of a spinal cord stimulator to&#xD;
        minimise the possible adverse effects related to the surgery.&#xD;
  &#xD;
        The SCS will start one month after surgery. The investigators will use a double-blind&#xD;
        cross-over design. The participants will receive three different stimulation parameters,&#xD;
        including sham stimulation, in a randomised order. The participants and the assessors will be&#xD;
        blinded to the stimulation parameters.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators aim to recruit up to 8 people with Parkinson's with significant gait&#xD;
        dysfunction which is resistant to medical therapy to this study. All participants will&#xD;
        receive implantation of a spinal cord stimulator at T8-10 levels. The procedure will be done&#xD;
        percutaneously. The spinal cord stimulation will be commenced 2-4 weeks after surgery to&#xD;
        allow time for recovery.&#xD;
  &#xD;
        Participants will receive 3 different stimulation parameters in randomised order as outlined&#xD;
        below:&#xD;
  &#xD;
          1. Burst stimulation&#xD;
  &#xD;
          2. High frequency stimulation&#xD;
  &#xD;
          3. Sham stimulation Each parameter will last for up to 6 weeks. Both the patients and the&#xD;
             researchers assessing the patients will be blinded to the settings parameters. At&#xD;
             baseline and at the end of each stimulation settings, the participants will undergo a&#xD;
             series of assessments (see secondary outcomes). At the end of the cross-over blinded&#xD;
             period, the participants will be unblinded and offered to continue with the parameter&#xD;
             that offered most symptomatic relief. The participants will then continue in this&#xD;
             setting in an open label phase for another 10 weeks before their final assessment at 7&#xD;
             months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">February 28, 2026</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants with Incidence of Treatment-Emergent Adverse Events</measure>
      <time_frame>Day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery</time_frame>
      <description>Safety of a 28-week SCS Intervention will be assessed by measuring the number of participants with adverse events that are related to treatment</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with Incidence of Serious Adverse Events</measure>
      <time_frame>Day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery</time_frame>
      <description>Safety of a 28-week SCS Intervention will be assessed by measuring the number of participants with serious adverse events</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants that complete the study</measure>
      <time_frame>Day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery</time_frame>
      <description>Safety of a 28-week SCS Intervention will be assessed by measuring the number of participants that complete the study</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>1. Mean change from baseline to week 28 in participant scores on the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part 3 motor subsection in the &quot;OFF&quot; and &quot;ON&quot; medication state</measure>
      <time_frame>Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery</time_frame>
      <description>Motor symptoms will be measured using the MDS-UPDRS part 3 motor subsection. Part III of the scale will be completed at baseline, visit 1 (1 day post-surgery), visit 2 (6 weeks post-surgery), visit 3 (12 weeks post-surgery), visit 4 (18 weeks post-surgery), visit 4 (28 weeks post-surgery).&#xD;
  The scale consists of four parts; Part I &quot;Non-motor experiences of daily living&quot; (13 questions), Part II &quot;Motor Experiences of daily living&quot; (13), Part III &quot;Motor Examination&quot; (33) and Part IV &quot;Motor Complications&quot; (6).&#xD;
  Each question has five responses that are linked to common clinical terms: 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. &quot;Slight&quot; refers to symptoms with sufficiently low frequency/intensity to cause no impact on function; &quot;Mild&quot; refers to symptoms of frequency/intensity sufficient to cause modest impact on function; &quot;Moderate&quot; refers to symptoms sufficiently frequent/intense to impact considerably, but not prevent, function; &quot;Severe&quot; refers to symptoms that prevent function.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Hoehn and Yahr Scoring Scale</measure>
      <time_frame>Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery</time_frame>
      <description>Scores range: 1-5. Higher scores mean a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in New Freezing of Gait Questionnaire</measure>
      <time_frame>Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery</time_frame>
      <description>The new freezing of gait questionnaire is a measure of freezing severity (total score range: 0-28) wherein higher scores represent worse freezing behaviour.&#xD;
  The outcome measures represent the change in freezing of gait questionnaire score from pre-intervention (baseline visit) to each post-intervention time point. A larger, positive value represents a greater reduction in freezing severity and a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in 10 meter walk test (10MW) performance (sec)</measure>
      <time_frame>Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery</time_frame>
      <description>Change in the duration to walk 10 meters (in seconds), both in ON-medication. A longer duration to perform the task represents a more impaired mobility.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Timed Up and Go (TUG) test Performance (sec)</measure>
      <time_frame>Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery</time_frame>
      <description>Change in the duration to perform the Timed-Up and Go (TUG) test in seconds, with and without a cognitive dual task, in ON-medication. The Timed Up and Go performance is a measure of mobility, and a longer duration to perform the task represents a more impaired mobility.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in 360° turning performance (sec)</measure>
      <time_frame>Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery</time_frame>
      <description>Change in the duration to turn 360° in place in ON medication, with and without a cognitive dual task. A longer duration to perform the task represents a more impaired mobility.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean change in objective, unsupervised quantification of participant motor impairment, using motion sensors</measure>
      <time_frame>Baseline, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery</time_frame>
      <description>Motor impairment will be determined based on recordings using five sensors (both arms and legs, and lower back) for the entire duration of the trial (PD Monitor, PD Neuroelectrics). Sensors will be placed before the SCS surgery and after each change in SCS parameter, up to the end of the open label phase (28 weeks).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in balance: objective measure of sway velocity on a force platform (metre/sec)</measure>
      <time_frame>Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery</time_frame>
      <description>Sway will be measured on a force platform before and after each SCS parameter change, up to 28 weeks post-intervention. Sway metric (sway velocity) will be collected at each time point in five different conditions, namely while standing on an hard surface with eyes open (condition 1) and closed (condition 2), on a soft surface with eyes open (condition 3) and closed (condition 4), and while tandem standing with eyes open (condition 5).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Non-motor Symptoms of PD</measure>
      <time_frame>Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery</time_frame>
      <description>Non Motor Symptoms Scale (NMSS) Minimum: 0, maximum: 360, higher score values indicate a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Quality of Life Measured by a 39-item Parkinson's Disease Questionnaire (PDQ-39)</measure>
      <time_frame>Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery</time_frame>
      <description>Parkinson's Disease Questionnaire - 39 (PDQ-39) is a self-administered questionnaire. It comprises of 39 questions, relating to eight key areas of health and daily activities, including both Motor and Non-motor symptoms. It is scored on a scale of zero to 100, with lower scores indicating better health and high scores more severe symptoms in change from Baseline to end of Maintenance.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">8</enrollment>
    <condition>Parkinson Disease</condition>
    <condition>Freezing of Gait</condition>
    <arm_group>
      <arm_group_label>High Frequency SCS</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will be randomly assigned to this arm for up to 6 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Burst SCS</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will be randomly assigned to this arm for up to 6 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham SCS</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Participants will be randomly assigned to this arm for up to 6 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Spinal Cord Stimulation - High Frequency SCS</intervention_name>
      <description>High Frequency-SCS consists of delivering electrical stimulation at frequencies equal to or greater than 1kHz.&#xD;
  This intervention will last up to 6 weeks.</description>
      <arm_group_label>High Frequency SCS</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Spinal Cord Stimulation - Burst SCS</intervention_name>
      <description>Burst SCS consists of closely spaced, high frequency stimuli delivered to the spinal cord.&#xD;
  This intervention will last up to 6 weeks.</description>
      <arm_group_label>Burst SCS</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Spinal Cord Stimulation - Sham SCS</intervention_name>
      <description>This intervention will last up to 6 weeks.</description>
      <arm_group_label>Sham SCS</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age: 45 ≤ X ≤ 85&#xD;
  &#xD;
            -  PD diagnosis based on UK Parkinson's disease society brain bank criteria&#xD;
  &#xD;
            -  Significant gait dysfunction, particularly freezing of gait, which is resistant to&#xD;
               optimal medical therapy&#xD;
  &#xD;
            -  Hoen and Yahr stage: 2-4 (in ON state)&#xD;
  &#xD;
            -  Stable dopaminergic treatment for at least two weeks before enrolment.&#xD;
  &#xD;
            -  Can provide informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Atypical or secondary parkinsonism e.g. vascular, drug-induced&#xD;
  &#xD;
            -  Major focal brain disorders (including malignancy or stroke)&#xD;
  &#xD;
            -  Recent (within 3 months)/current use of acetylcholinesterase inhibitors or&#xD;
               antidopaminergic drugs&#xD;
  &#xD;
            -  Concomitant treatment with deep brain stimulation&#xD;
  &#xD;
            -  Neurological, vestibular, visual or orthopaedic diagnosis significantly interfering&#xD;
               with gait&#xD;
  &#xD;
            -  Pregnant women or planning to become pregnant&#xD;
  &#xD;
            -  Significant chronic back pain&#xD;
  &#xD;
            -  Spinal anatomical abnormalities precluding SCS surgery&#xD;
  &#xD;
            -  Major cognitive or psychiatric illness&#xD;
  &#xD;
            -  Concomitant or recent (less than 4 months) enrolment in an interventional research&#xD;
               trial.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yen Tai</last_name>
      <role>Principal Investigator</role>
      <affiliation>Imperial College London</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yen Tai</last_name>
      <phone>+442033111182</phone>
      <email>yen.tai@imperial.ac.uk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Imperial College London</name>
        <address>
          <city>London</city>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Matteo Ciocca</last_name>
        <email>m.ciocca20@imperial.ac.uk</email>
      </contact>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>January 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Spinal Cord Stimulation</keyword>
    <keyword>Parkinson's</keyword>
    <keyword>Gait Disorders</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>
      <ipd_description>Group data can be made available upon request, following completion and publication of results</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06005584
  org study id: 22CX7894
  nct id: NCT06005584
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  Parkinson's disease (PD) is the second commonest neurodegenerative disorder, affecting over
        145,000 people in the UK. Initially, PD patients experience slowness of movements, limb
        stiffness, and tremor.
  
        With progressive loss of neurons over time, many patients start to experience balance and
        walking problems, and falls, which are resistant to currently available treatments. Falls can
        lead to fractures and nursing home admission, and can significantly shorten patients' life
        expectancy.
  
        In this pilot study, the investigators will investigate the effects of spinal cord
        stimulation (SCS) on gait and balance in PD. Some open-labelled studies have shown possible
        beneficial effects of SCS in PD, although it is uncertain which type of PD patients will
        benefit most and which stimulation parameters work best. The investigators will assess the
        effects of SCS on posture and gait using a series of clinical, laboratory, imaging, and
        wearable measurements.
  
        The participants will receive a percutaneous implantation of a spinal cord stimulator to
        minimise the possible adverse effects related to the surgery.
  
        The SCS will start one month after surgery. The investigators will use a double-blind
        cross-over design. The participants will receive three different stimulation parameters,
        including sham stimulation, in a randomised order. The participants and the assessors will be
        blinded to the stimulation parameters.
  The investigators aim to recruit up to 8 people with Parkinson's with significant gait
        dysfunction which is resistant to medical therapy to this study. All participants will
        receive implantation of a spinal cord stimulator at T8-10 levels. The procedure will be done
        percutaneously. The spinal cord stimulation will be commenced 2-4 weeks after surgery to
        allow time for recovery.
  
        Participants will receive 3 different stimulation parameters in randomised order as outlined
        below:
  
          1. Burst stimulation
  
          2. High frequency stimulation
  
          3. Sham stimulation Each parameter will last for up to 6 weeks. Both the patients and the
             researchers assessing the patients will be blinded to the settings parameters. At
             baseline and at the end of each stimulation settings, the participants will undergo a
             series of assessments (see secondary outcomes). At the end of the cross-over blinded
             period, the participants will be unblinded and offered to continue with the parameter
             that offered most symptomatic relief. The participants will then continue in this
             setting in an open label phase for another 10 weeks before their final assessment at 7
             months.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  measure: Number of Participants with Incidence of Treatment-Emergent Adverse Events
  time frame: Day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
  description: Safety of a 28-week SCS Intervention will be assessed by measuring the number of participants with adverse events that are related to treatment
  measure: Number of Participants with Incidence of Serious Adverse Events
  time frame: Day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
  description: Safety of a 28-week SCS Intervention will be assessed by measuring the number of participants with serious adverse events
  measure: Number of Participants that complete the study
  time frame: Day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
  description: Safety of a 28-week SCS Intervention will be assessed by measuring the number of participants that complete the study
  measure: 1. Mean change from baseline to week 28 in participant scores on the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part 3 motor subsection in the "OFF" and "ON" medication state
  time frame: Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
  description: Motor symptoms will be measured using the MDS-UPDRS part 3 motor subsection. Part III of the scale will be completed at baseline, visit 1 (1 day post-surgery), visit 2 (6 weeks post-surgery), visit 3 (12 weeks post-surgery), visit 4 (18 weeks post-surgery), visit 4 (28 weeks post-surgery).
  The scale consists of four parts; Part I "Non-motor experiences of daily living" (13 questions), Part II "Motor Experiences of daily living" (13), Part III "Motor Examination" (33) and Part IV "Motor Complications" (6).
  Each question has five responses that are linked to common clinical terms: 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. "Slight" refers to symptoms with sufficiently low frequency/intensity to cause no impact on function; "Mild" refers to symptoms of frequency/intensity sufficient to cause modest impact on function; "Moderate" refers to symptoms sufficiently frequent/intense to impact considerably, but not prevent, function; "Severe" refers to symptoms that prevent function.
  measure: Change in Hoehn and Yahr Scoring Scale
  time frame: Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
  description: Scores range: 1-5. Higher scores mean a worse outcome.
  measure: Change in New Freezing of Gait Questionnaire
  time frame: Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
  description: The new freezing of gait questionnaire is a measure of freezing severity (total score range: 0-28) wherein higher scores represent worse freezing behaviour.
  The outcome measures represent the change in freezing of gait questionnaire score from pre-intervention (baseline visit) to each post-intervention time point. A larger, positive value represents a greater reduction in freezing severity and a better outcome.
  measure: Changes in 10 meter walk test (10MW) performance (sec)
  time frame: Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
  description: Change in the duration to walk 10 meters (in seconds), both in ON-medication. A longer duration to perform the task represents a more impaired mobility.
  measure: Changes in Timed Up and Go (TUG) test Performance (sec)
  time frame: Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
  description: Change in the duration to perform the Timed-Up and Go (TUG) test in seconds, with and without a cognitive dual task, in ON-medication. The Timed Up and Go performance is a measure of mobility, and a longer duration to perform the task represents a more impaired mobility.
  measure: Changes in 360° turning performance (sec)
  time frame: Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
  description: Change in the duration to turn 360° in place in ON medication, with and without a cognitive dual task. A longer duration to perform the task represents a more impaired mobility.
  measure: Mean change in objective, unsupervised quantification of participant motor impairment, using motion sensors
  time frame: Baseline, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
  description: Motor impairment will be determined based on recordings using five sensors (both arms and legs, and lower back) for the entire duration of the trial (PD Monitor, PD Neuroelectrics). Sensors will be placed before the SCS surgery and after each change in SCS parameter, up to the end of the open label phase (28 weeks).
  measure: Change in balance: objective measure of sway velocity on a force platform (metre/sec)
  time frame: Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
  description: Sway will be measured on a force platform before and after each SCS parameter change, up to 28 weeks post-intervention. Sway metric (sway velocity) will be collected at each time point in five different conditions, namely while standing on an hard surface with eyes open (condition 1) and closed (condition 2), on a soft surface with eyes open (condition 3) and closed (condition 4), and while tandem standing with eyes open (condition 5).
  measure: Changes in Non-motor Symptoms of PD
  time frame: Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
  description: Non Motor Symptoms Scale (NMSS) Minimum: 0, maximum: 360, higher score values indicate a worse outcome.
  measure: Changes in Quality of Life Measured by a 39-item Parkinson's Disease Questionnaire (PDQ-39)
  time frame: Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
  description: Parkinson's Disease Questionnaire - 39 (PDQ-39) is a self-administered questionnaire. It comprises of 39 questions, relating to eight key areas of health and daily activities, including both Motor and Non-motor symptoms. It is scored on a scale of zero to 100, with lower scores indicating better health and high scores more severe symptoms in change from Baseline to end of Maintenance.
  arm group label: High Frequency SCS
  arm group type: Active Comparator
  description: Participants will be randomly assigned to this arm for up to 6 weeks
  arm group label: Burst SCS
  arm group type: Active Comparator
  description: Participants will be randomly assigned to this arm for up to 6 weeks
  arm group label: Sham SCS
  arm group type: Sham Comparator
  description: Participants will be randomly assigned to this arm for up to 6 weeks
  intervention type: Device
  intervention name: Spinal Cord Stimulation - High Frequency SCS
  description: High Frequency-SCS consists of delivering electrical stimulation at frequencies equal to or greater than 1kHz.
  This intervention will last up to 6 weeks.
  arm group label: High Frequency SCS
  intervention type: Device
  intervention name: Spinal Cord Stimulation - Burst SCS
  description: Burst SCS consists of closely spaced, high frequency stimuli delivered to the spinal cord.
  This intervention will last up to 6 weeks.
  arm group label: Burst SCS
  intervention type: Device
  intervention name: Spinal Cord Stimulation - Sham SCS
  description: This intervention will last up to 6 weeks.
  arm group label: Sham SCS
  criteria: 
  gender: All
  minimum age: 45 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Yen Tai
  role: Principal Investigator
  affiliation: Imperial College London
  last name: Yen Tai
  phone: +442033111182
  email: yen.tai@imperial.ac.uk
  facility: 
  status: Recruiting
  contact: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Parkinson Disease
  sharing ipd: No
  ipd description: Group data can be made available upon request, following completion and publication of results