<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/NCT01701544</url>
  </required_header>
  <id_info>
    <org_study_id>11/0516</org_study_id>
    <nct_id>NCT01701544</nct_id>
  </id_info>
  <brief_title>Nucleus Basalis Deep Brain Stimulation for Thinking &amp; Memory Problems in Parkinson's.</brief_title>
  <official_title>Double Blind, Randomised, Single Centre, Crossover Pilot Trial of Bilateral Nucleus Basalis of Meynert Deep Brain Stimulation to Improve Cognitive Deficits in Patients With Parkinson's Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University College, London</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We will perform a pilot study to evaluate the effectiveness of human NBM DBS at improving&#xD;
      cognitive deficits in PD patients referred and eligible for conventional DBS treatment for&#xD;
      coexisting motor impairments. Six patients with PD with both motor fluctuations and cognitive&#xD;
      impairments (including but not restricted to deficits in attention and working memory) will&#xD;
      have bilateral electrodes implanted to ensure that superficial contacts lie in the&#xD;
      conventional motor GPi target, while the deepest electrical contacts lie in the NBM- (see&#xD;
      figure 1). We will place electrodes using our conventional image guided, stereotactic&#xD;
      frame-based procedure currently used in patients at NHNN. Patients will be randomised into 2&#xD;
      groups in a crossover trial design to have 3 month periods of NBM stimulation switched on or&#xD;
      switched off separated by a 1 month washout period, following which the patient will cross&#xD;
      over to have the opposite condition for a further 3 months- see timeline. At the end of the&#xD;
      crossover period, all patients will be invited for continued follow up with stimulation&#xD;
      switched on and will have neuropsychological evaluations at 6 monthly intervals. Patients&#xD;
      will be given the option of receiving additional conventional stimulation to the motor GPi,&#xD;
      through the higher contacts of each electrode, at the end of the crossover period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Abbreviated cognitive battery</measure>
    <time_frame>6 months</time_frame>
    <description>Differences between each item of the abbreviated cognitive battery scores between patients after 3 months ON stimulation and 3 months OFF stimulation.&#xD;
CVLT-II,Verbal Fluency,Simple &amp; Choice RT (CANTAB),Digit span,Posner's covert attention test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Minimental State Examination</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DRS-2</measure>
    <time_frame>6 months</time_frame>
    <description>Dementia Rating Scale-2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SRM (Faces)</measure>
    <time_frame>6 months</time_frame>
    <description>Short Recognition Memory for faces</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WAIS-III (Letter number sequencing, Arithmetic)</measure>
    <time_frame>6 months</time_frame>
    <description>Wechsler Abbreviated Scale of Intelligence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FAST</measure>
    <time_frame>6 months</time_frame>
    <description>Florida Apraxia Screening test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NPI</measure>
    <time_frame>6 months</time_frame>
    <description>Neuropsychiatric Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BDS</measure>
    <time_frame>6 months</time_frame>
    <description>Blessed Dementia Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HAM-D</measure>
    <time_frame>6 months</time_frame>
    <description>Hamilton Depression scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MDS UPDRS</measure>
    <time_frame>6 months</time_frame>
    <description>Movement Disorders Society - Unified Parkinson's disease Rating scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PDQ39</measure>
    <time_frame>6 months</time_frame>
    <description>Parkinson's disease quality of life questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GFQ</measure>
    <time_frame>6 months</time_frame>
    <description>Gait and falls questioannaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NMS Quest</measure>
    <time_frame>6 months</time_frame>
    <description>Non Motor Symptoms Questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Dementia in Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>NBM DBS Off</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>NBM DBS switched off</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NBM DBS On</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>NBM DBS Switched On</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NBM DBS</intervention_name>
    <description>Deep Brain Stimulation targeting the Nucleus Basalis of Meynert</description>
    <arm_group_label>NBM DBS Off</arm_group_label>
    <arm_group_label>NBM DBS On</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients will meet Queen Square brain bank criteria for the diagnosis of PD and&#xD;
             will have motor fluctuations (off periods and/or L-dopa induced dyskinesias) in&#xD;
             response to medications that are known to improve with GPi DBS, and will be&#xD;
             appropriate candidates for GPi DBS aside from the coexistence of cognitive impairment.&#xD;
&#xD;
        Patients will be aged between 35 and 80 years.&#xD;
&#xD;
        Patients will be able to give informed consent.&#xD;
&#xD;
        Patients will meet criteria for PD dementia. Patients will have a MMSE score between 26 and&#xD;
        lower cutoff of 21 to restrict the sample to those with mild dementia and cognitive&#xD;
        impairment. This will be equivalent to an age and education adjusted scaled score of&#xD;
        greater than 5 and lower than 9 (mildly impaired range) on the Mattis Dementia Rating&#xD;
        Scale-2.&#xD;
&#xD;
        Patients will have only minimal atrophy on pre-operative brain MRI scans.&#xD;
&#xD;
        Patients will be living at home and will have a carer living with them e.g. their spouse&#xD;
&#xD;
        Able to comply with trial protocol and willing to attend clinic necessary visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis or suspicion of other cause for parkinsonism or dementia.&#xD;
&#xD;
        Known abnormality on CT or MRI brain imaging considered likely to compromise compliance&#xD;
        with trial protocol.&#xD;
&#xD;
        Prior intra-cerebral surgical intervention for Parkinson's disease including Deep Brain&#xD;
        stimulation, lesional surgery, growth factor administration, gene therapy or cell&#xD;
        transplant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Foltynie, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCL Institute of Neurology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Hospital for Neurology &amp; Neurosurgery</name>
      <address>
        <city>London</city>
        <zip>WC1N 3BG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>October 28, 2016</last_update_submitted>
  <last_update_submitted_qc>October 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 31, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT01701544
org study id: 11/0516
nct id: NCT01701544
lead sponsor: 
has dmc: Yes
We will perform a pilot study to evaluate the effectiveness of human NBM DBS at improving
      cognitive deficits in PD patients referred and eligible for conventional DBS treatment for
      coexisting motor impairments. Six patients with PD with both motor fluctuations and cognitive
      impairments (including but not restricted to deficits in attention and working memory) will
      have bilateral electrodes implanted to ensure that superficial contacts lie in the
      conventional motor GPi target, while the deepest electrical contacts lie in the NBM- (see
      figure 1). We will place electrodes using our conventional image guided, stereotactic
      frame-based procedure currently used in patients at NHNN. Patients will be randomised into 2
      groups in a crossover trial design to have 3 month periods of NBM stimulation switched on or
      switched off separated by a 1 month washout period, following which the patient will cross
      over to have the opposite condition for a further 3 months- see timeline. At the end of the
      crossover period, all patients will be invited for continued follow up with stimulation
      switched on and will have neuropsychological evaluations at 6 monthly intervals. Patients
      will be given the option of receiving additional conventional stimulation to the motor GPi,
      through the higher contacts of each electrode, at the end of the crossover period.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Abbreviated cognitive battery
time frame: 6 months
description: Differences between each item of the abbreviated cognitive battery scores between patients after 3 months ON stimulation and 3 months OFF stimulation.
CVLT-II,Verbal Fluency,Simple & Choice RT (CANTAB),Digit span,Posner's covert attention test
measure: Minimental State Examination
time frame: 6 months
measure: DRS-2
time frame: 6 months
description: Dementia Rating Scale-2
measure: SRM (Faces)
time frame: 6 months
description: Short Recognition Memory for faces
measure: WAIS-III (Letter number sequencing, Arithmetic)
time frame: 6 months
description: Wechsler Abbreviated Scale of Intelligence
measure: FAST
time frame: 6 months
description: Florida Apraxia Screening test
measure: NPI
time frame: 6 months
description: Neuropsychiatric Inventory
measure: BDS
time frame: 6 months
description: Blessed Dementia Scale
measure: HAM-D
time frame: 6 months
description: Hamilton Depression scale
measure: MDS UPDRS
time frame: 6 months
description: Movement Disorders Society - Unified Parkinson's disease Rating scale
measure: PDQ39
time frame: 6 months
description: Parkinson's disease quality of life questionnaire
measure: GFQ
time frame: 6 months
description: Gait and falls questioannaire
measure: NMS Quest
time frame: 6 months
description: Non Motor Symptoms Questionnaire
arm group label: NBM DBS Off
arm group type: Sham Comparator
description: NBM DBS switched off
arm group label: NBM DBS On
arm group type: Active Comparator
description: NBM DBS Switched On
intervention type: Device
intervention name: NBM DBS
description: Deep Brain Stimulation targeting the Nucleus Basalis of Meynert
arm group label: NBM DBS Off
arm group label: NBM DBS On
criteria: 
gender: All
minimum age: 35 Years
maximum age: 80 Years
healthy volunteers: No
last name: Thomas Foltynie, PhD
role: Principal Investigator
affiliation: UCL Institute of Neurology
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Parkinson Disease