<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/NCT02263937</url>
  </required_header>
  <id_info>
    <org_study_id>13/0538</org_study_id>
    <nct_id>NCT02263937</nct_id>
  </id_info>
  <brief_title>Deep Brain Stimulation for Patients With Dementia With Lewy Bodies</brief_title>
  <official_title>Double Blind, Randomised, Dual Centre, Crossover, Pilot Trial of Bilateral Nucleus Basalis of Meynert Deep Brain Stimulation to Improve Cognitive Deficits in Patients With Dementia With Lewy Bodies.</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>
      This trial aims to collect pilot data to explore whether bilateral deep brain stimulation&#xD;
      (DBS) of the Nucleus Basalis of Meynert (NBM) has beneficial effects on memory and thinking&#xD;
      impairments among individuals with Dementia with Lewy Bodies (DLB).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We will perform a pilot study to evaluate the effectiveness of human NBM DBS at improving&#xD;
      cognitive deficits in DLB patients. Six patients with DLB with moderate cognitive impairments&#xD;
      (including but not restricted to deficits in attention and working memory) will have&#xD;
      bilateral DBS electrodes implanted to ensure that superficial contacts lie in the motor&#xD;
      Globus Pallidum interna (GPi) target, while the deepest electrical contacts lie in the NBM.&#xD;
      We will place electrodes using our conventional image-guided, stereotactic frame-based&#xD;
      procedure. Once the surgical wounds have healed, patients will be randomised into 2 groups in&#xD;
      a crossover trial design to have 6 week periods of NBM stimulation switched on or switched&#xD;
      off separated by a 2 week washout period, following which the patient will cross over to have&#xD;
      the opposite condition for a further 6 weeks. Outcome measures collected at the 6 weeks and&#xD;
      14 weeks timepoints will be compared according to whether each patient was ON or OFF&#xD;
      stimulation at that timepoint.&#xD;
&#xD;
      At the end of the crossover period, all patients will be invited for continued follow up with&#xD;
      stimulation switched on and will have neuropsychological evaluations at 6 monthly intervals.&#xD;
      Patients will be given the option of receiving additional conventional stimulation to the&#xD;
      motor GPi, through the higher contacts of each electrode, at the end of the crossover period&#xD;
      if required for any coexisting Parkinsonian motor complications of DLB.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</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>Hopkins Verbal Learning test</measure>
    <time_frame>Comparing ON v OFF stimulation at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Verbal Fluency</measure>
    <time_frame>Comparing ON v OFF stimulation at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Simple &amp; Choice Reaction time task</measure>
    <time_frame>Comparing ON v OFF stimulation at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Wechsler Adult Intelligence scale (WAIS IV) Digit Span</measure>
    <time_frame>Comparing ON v OFF stimulation at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Posner's Covert Attention test</measure>
    <time_frame>Comparing ON v OFF at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinician's Assessment of Fluctuations scale</measure>
    <time_frame>Comparing ON v OFF stimulation at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Minimental State Examination (MMSE)</measure>
    <time_frame>Comparing ON v OFF stimulation at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dementia Rating Scale (DRS-2)</measure>
    <time_frame>Comparing ON v OFF stimulation at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wechsler Abbreviated Scale of Intelligence (WASI)</measure>
    <time_frame>Comparing ON v OFF stimulation at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Recognition Memory</measure>
    <time_frame>Comparing ON v OFF stimulation at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wechsler Adult Intelligence Scale IV -Letter, Number sequencing</measure>
    <time_frame>Comparing ON v OFF stimulation at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trail Making test</measure>
    <time_frame>Comparing ON v OFF stimulation at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroop test</measure>
    <time_frame>Comparing ON v OFF stimulation at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wechsler Adult Intelligence Scale IV - Symbol search</measure>
    <time_frame>Comparing ON v OFF stimulation at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Judgement of Line Orientation</measure>
    <time_frame>Comparing ON v OFF stimulation at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>North East Visual Hallucinations Interview</measure>
    <time_frame>Comparing ON v OFF stimulation at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropsychiatric Inventory</measure>
    <time_frame>Comparing ON v OFF stimulation at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Florida Apraxia Screening test</measure>
    <time_frame>Comparing ON v OFF stimulation at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression Scale</measure>
    <time_frame>Comparing ON v OFF at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hamilton Depression scale</measure>
    <time_frame>Comparing ON v OFF at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hamilton Anxiety Scale</measure>
    <time_frame>Comparing ON v OFF stimulation at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Starkstein Apathy Rating scale</measure>
    <time_frame>Comparing ON v OFF stimulation at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Movement Disorders Society- Unified Parkinson's Disease Rating Scale</measure>
    <time_frame>Comparing ON v OFF stimulation at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freezing of Gait- questionnaire</measure>
    <time_frame>Comparing ON v OFF stimulation at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scales for outcome in Parkinson's disease (SCOPA - AUT)</measure>
    <time_frame>Comparing ON v OFF stimulation at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life- Alzheimer's Disease</measure>
    <time_frame>Comparing ON v OFF stimulation at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mayo Fluctuations Composite Scale</measure>
    <time_frame>Comparing ON v OFF stimulation at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blessed Dementia scale</measure>
    <time_frame>Comparing ON v OFF stimulation at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Carer Strain Index</measure>
    <time_frame>Comparing ON v OFF stimulation at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form 36</measure>
    <time_frame>Comparing ON v OFF stimulation at 6 weeks &amp; 14 weeks according to stimulation status</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Throughout trial period</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Dementia With Lewy Bodies</condition>
  <arm_group>
    <arm_group_label>Bilateral Nucleus Basalis Meynert DBS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>6 week period of active NBM DBS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Nucleus Basalis Meynert DBS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>6 week period of Sham DBS</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bilateral Nucleus Basalis Meynert DBS</intervention_name>
    <description>Low frequency stimulation applied using standard Deep brain stimualtion hardware.</description>
    <arm_group_label>Bilateral Nucleus Basalis Meynert DBS</arm_group_label>
    <other_name>Active Deep Brain Stimulation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sham Nucleus Basalis Meynert DBS</intervention_name>
    <description>DBS system switched off.</description>
    <arm_group_label>Sham Nucleus Basalis Meynert DBS</arm_group_label>
    <other_name>Sham DBS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  DLB Consortium Criteria for diagnosis&#xD;
&#xD;
          -  Score between 2 &amp; 12 on Clinician Assessment of Fluctuations scale&#xD;
&#xD;
          -  MMSE score between 21 and 27&#xD;
&#xD;
          -  Appropriate Surgical candidates in terms of general health&#xD;
&#xD;
          -  Aged between 50 &amp; 80&#xD;
&#xD;
          -  Able to give Informed consent&#xD;
&#xD;
          -  Living at home with Carer&#xD;
&#xD;
          -  Able to comply with protocol&#xD;
&#xD;
          -  On stable dosage of cholinesterase inhibitor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of other cause for dementia&#xD;
&#xD;
          -  Abnormality on brain imaging considered likely to compromise compliance with trial&#xD;
             protocol.&#xD;
&#xD;
          -  Prior intracerebral surgical intervention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Foltynie, MB BS MRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCL Institute of Neurology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCL Institute of Neurology</name>
      <address>
        <city>London</city>
        <zip>WC1N 3BG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Newcastle</name>
      <address>
        <city>Newcastle</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</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>Dementia</mesh_term>
    <mesh_term>Lewy Body 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/NCT02263937
org study id: 13/0538
nct id: NCT02263937
lead sponsor: 
has dmc: Yes
This trial aims to collect pilot data to explore whether bilateral deep brain stimulation
      (DBS) of the Nucleus Basalis of Meynert (NBM) has beneficial effects on memory and thinking
      impairments among individuals with Dementia with Lewy Bodies (DLB).
We will perform a pilot study to evaluate the effectiveness of human NBM DBS at improving
      cognitive deficits in DLB patients. Six patients with DLB with moderate cognitive impairments
      (including but not restricted to deficits in attention and working memory) will have
      bilateral DBS electrodes implanted to ensure that superficial contacts lie in the motor
      Globus Pallidum interna (GPi) target, while the deepest electrical contacts lie in the NBM.
      We will place electrodes using our conventional image-guided, stereotactic frame-based
      procedure. Once the surgical wounds have healed, patients will be randomised into 2 groups in
      a crossover trial design to have 6 week periods of NBM stimulation switched on or switched
      off separated by a 2 week washout period, following which the patient will cross over to have
      the opposite condition for a further 6 weeks. Outcome measures collected at the 6 weeks and
      14 weeks timepoints will be compared according to whether each patient was ON or OFF
      stimulation at that timepoint.

      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
      if required for any coexisting Parkinsonian motor complications of DLB.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Hopkins Verbal Learning test
time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
measure: Verbal Fluency
time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
measure: Simple & Choice Reaction time task
time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
measure: Wechsler Adult Intelligence scale (WAIS IV) Digit Span
time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
measure: Posner's Covert Attention test
time frame: Comparing ON v OFF at 6 weeks & 14 weeks according to stimulation status
measure: Clinician's Assessment of Fluctuations scale
time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
measure: Minimental State Examination (MMSE)
time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
measure: Dementia Rating Scale (DRS-2)
time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
measure: Wechsler Abbreviated Scale of Intelligence (WASI)
time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
measure: Short Recognition Memory
time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
measure: Wechsler Adult Intelligence Scale IV -Letter, Number sequencing
time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
measure: Trail Making test
time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
measure: Stroop test
time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
measure: Wechsler Adult Intelligence Scale IV - Symbol search
time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
measure: Judgement of Line Orientation
time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
measure: North East Visual Hallucinations Interview
time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
measure: Neuropsychiatric Inventory
time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
measure: Florida Apraxia Screening test
time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
measure: Clinical Global Impression Scale
time frame: Comparing ON v OFF at 6 weeks & 14 weeks according to stimulation status
measure: Hamilton Depression scale
time frame: Comparing ON v OFF at 6 weeks & 14 weeks according to stimulation status
measure: Hamilton Anxiety Scale
time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
measure: Starkstein Apathy Rating scale
time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
measure: Movement Disorders Society- Unified Parkinson's Disease Rating Scale
time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
measure: Freezing of Gait- questionnaire
time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
measure: Scales for outcome in Parkinson's disease (SCOPA - AUT)
time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
measure: Quality of Life- Alzheimer's Disease
time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
measure: Mayo Fluctuations Composite Scale
time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
measure: Blessed Dementia scale
time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
measure: Carer Strain Index
time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
measure: Short Form 36
time frame: Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status
measure: Adverse Events
time frame: Throughout trial period
arm group label: Bilateral Nucleus Basalis Meynert DBS
arm group type: Active Comparator
description: 6 week period of active NBM DBS
arm group label: Sham Nucleus Basalis Meynert DBS
arm group type: Sham Comparator
description: 6 week period of Sham DBS
intervention type: Procedure
intervention name: Bilateral Nucleus Basalis Meynert DBS
description: Low frequency stimulation applied using standard Deep brain stimualtion hardware.
arm group label: Bilateral Nucleus Basalis Meynert DBS
other name: Active Deep Brain Stimulation
intervention type: Procedure
intervention name: Sham Nucleus Basalis Meynert DBS
description: DBS system switched off.
arm group label: Sham Nucleus Basalis Meynert DBS
other name: Sham DBS
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
last name: Thomas Foltynie, MB BS MRCP
role: Principal Investigator
affiliation: UCL Institute of Neurology
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Dementia
mesh term: Lewy Body Disease