<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/NCT02975193</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201601780</org_study_id>
    <secondary_id>F30NS111841</secondary_id>
    <nct_id>NCT02975193</nct_id>
  </id_info>
  <brief_title>Neural Correlates of Cognition in Parkinson's Disease</brief_title>
  <official_title>Neural Correlates of Cognition in Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</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>
      Cognitive impairment in Parkinson's disease (PD) has far-reaching effects on both motor&#xD;
      outcomes and quality of life in PD patients. Furthermore, deep brain stimulation (DBS), now&#xD;
      an evidence-based treatment for certain cases of PD, has the risk of causing deficits in&#xD;
      multiple areas of cognition.&#xD;
&#xD;
      As such, the purpose of this study is to understand the neuroanatomical and neurophysiologic&#xD;
      basis for impaired cognition in PD. The aim is to identify neural correlates of cognition by&#xD;
      measuring brain signal activity while PD patients are engaged in cognition on a computer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Participants: For this study, the investigators will recruit 75 Parkinson's disease&#xD;
      (PD) patients that are undergoing deep brain stimulation (DBS) as routine standard of care.&#xD;
&#xD;
      Screening: For healthy control participants, investigators will approach adults, aged 18-90,&#xD;
      for possible involvement in our study. Potential participants will be asked if they have ever&#xD;
      been diagnosed with a movement disorder, psychiatric disorder, or dementia. For PD patients&#xD;
      undergoing evaluation for DBS, investigators will first consult with their neurologist and&#xD;
      neurosurgeon. Next, investigators will approach the participant and explain the study.&#xD;
&#xD;
      PD Participants: As part of the usual DBS process at University of Florida (UF), PD&#xD;
      participants will be asked to participate in this trial. There are three evaluation time&#xD;
      points: before surgery, during surgery, and possibly after surgery. Before surgery, the PD&#xD;
      patients will complete standardized questionnaires and be trained on a computer game to&#xD;
      assess cognition. During surgery, the participants will play the same computer game while&#xD;
      brain signals are recorded. When the patients return to University of Florida for DBS&#xD;
      programming visits within 48 months after surgery, they will repeat the standardized&#xD;
      questionnaires and computer game once again.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">October 25, 2020</completion_date>
  <primary_completion_date type="Actual">October 25, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in behavioral performance</measure>
    <time_frame>Baseline, before surgery, during surgery, and up to 2 years after surgery</time_frame>
    <description>Behavioral performance will be assessed by the computer game that assess cognition. All computer games used in this study will have a similar form. The computer will record responses to each trial during the computer game.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Score on Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS)</measure>
    <time_frame>Baseline, before surgery, during surgery, and up to 2 years after surgery</time_frame>
    <description>Assess the scores from a standard clinical questionnaire called QUIP-RS. Scores range from 0 to 112.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local field potential brain signal</measure>
    <time_frame>At time of surgery</time_frame>
    <description>Measuring Brain signal while Parkinson's disease patients play a computer game during surgery. Local field potential is measured in Hertz (Hz)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Healthy adults ages 18-90 without movement disorders, psychiatric disorders, or dementia. They will complete computer games and questionnaires at one time point.&#xD;
Specific interventions: Computer task assessing cognition, Impulsive-Compulsive Disorders in Parkinson's Disease, Montreal Cognitive Assessment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parkinson's disease group with DBS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Parkinson's disease patients who have elected to receive DBS for treatment of their side effects of PD consent to complete computer games and questionnaires at baseline, computer games during deep brain stimulation, and computer games and questionnaires up to 2 years after surgery.&#xD;
Specific interventions: Computer task assessing cognition, Impulsive-Compulsive Disorders in Parkinson's Disease, Montreal Cognitive Assessment</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Computer task assessing cognition</intervention_name>
    <description>Participants will complete a short computer game to assess cognition.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Parkinson's disease group with DBS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Impulsive-Compulsive Disorders in Parkinson's Disease</intervention_name>
    <description>Standard clinical questionnaire</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Parkinson's disease group with DBS</arm_group_label>
    <other_name>QUIP-RS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Deep Brain Stimulation Surgery</intervention_name>
    <description>DBS surgery for the implantation of electrodes for the treatment of motor disorders.</description>
    <arm_group_label>Parkinson's disease group with DBS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        PD-DBS Participants:&#xD;
&#xD;
          -  Inclusion Criteria: Persons undergoing DBS surgery for the implantation of electrodes&#xD;
             for the treatment of motor disorders&#xD;
&#xD;
          -  Exclusion Criteria: Failure of the DBS surgical candidacy screening process&#xD;
&#xD;
        Non-DBS PD Participants:&#xD;
&#xD;
          -  Inclusion Criteria:Persons diagnosed with idiopathic Parkinson's disease and have not&#xD;
             received and are not currently scheduled for DBS.&#xD;
&#xD;
          -  Exclusion Criteria: Individuals that :&#xD;
&#xD;
               -  that have been diagnosed with dementia or other serious brain diseases or&#xD;
                  disorders such as strokes, traumatic brain injury, or brain tumor (the exception&#xD;
                  is Parkinson's disease)&#xD;
&#xD;
               -  who have had drug or alcohol abuse within the past 12 months&#xD;
&#xD;
               -  with severe sensory difficulties such as impaired vision or hearing&#xD;
&#xD;
               -  currently experiencing significant depression or sadness&#xD;
&#xD;
               -  with a history of schizophrenia or other serious mental health problems&#xD;
&#xD;
               -  using cognitive medications (e.g., Aricept) or stimulants (e.g., Adderall)&#xD;
&#xD;
               -  who have undergone deep brain stimulation, fetal cell implants, or other brain&#xD;
                  surgeries&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aysegul Gunduz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Allcock LM, Rowan EN, Steen IN, Wesnes K, Kenny RA, Burn DJ. Impaired attention predicts falling in Parkinson's disease. Parkinsonism Relat Disord. 2009 Feb;15(2):110-5. doi: 10.1016/j.parkreldis.2008.03.010. Epub 2008 May 19.</citation>
    <PMID>18487069</PMID>
  </reference>
  <reference>
    <citation>Awh E, Vogel EK, Oh SH. Interactions between attention and working memory. Neuroscience. 2006 Apr 28;139(1):201-8. doi: 10.1016/j.neuroscience.2005.08.023. Epub 2005 Dec 1.</citation>
    <PMID>16324792</PMID>
  </reference>
  <reference>
    <citation>Baunez C, Lardeux S. Frontal cortex-like functions of the subthalamic nucleus. Front Syst Neurosci. 2011 Oct 11;5:83. doi: 10.3389/fnsys.2011.00083. eCollection 2011.</citation>
    <PMID>22013416</PMID>
  </reference>
  <reference>
    <citation>Filoteo JV, Delis DC, Salmon DP, Demadura T, Roman MJ, Shults CW. An examination of the nature of attentional deficits in patients with Parkinson's disease: evidence from a spatial orienting task. J Int Neuropsychol Soc. 1997 Jul;3(4):337-47.</citation>
    <PMID>9260443</PMID>
  </reference>
  <reference>
    <citation>Gabrieli, J. D., Singh, J., Stebbins, G. T., &amp; Goetz, C. G. (1996). Reduced working memory span in Parkinson's disease: Evidence for the role of frontostriatal system in working and strategic memory. Neuropsychology, 10(3), 322.</citation>
  </reference>
  <reference>
    <citation>Henry JD, Crawford JR. Verbal fluency deficits in Parkinson's disease: a meta-analysis. J Int Neuropsychol Soc. 2004 Jul;10(4):608-22. doi: 10.1017/S1355617704104141.</citation>
    <PMID>15327739</PMID>
  </reference>
  <reference>
    <citation>Itti L, Koch C. Computational modelling of visual attention. Nat Rev Neurosci. 2001 Mar;2(3):194-203. doi: 10.1038/35058500.</citation>
    <PMID>11256080</PMID>
  </reference>
  <reference>
    <citation>Jahanshahi M, Ardouin CM, Brown RG, Rothwell JC, Obeso J, Albanese A, Rodriguez-Oroz MC, Moro E, Benabid AL, Pollak P, Limousin-Dowsey P. The impact of deep brain stimulation on executive function in Parkinson's disease. Brain. 2000 Jun;123 ( Pt 6):1142-54. doi: 10.1093/brain/123.6.1142.</citation>
    <PMID>10825353</PMID>
  </reference>
  <reference>
    <citation>Kim HJ, Jeon BS, Paek SH. Nonmotor Symptoms and Subthalamic Deep Brain Stimulation in Parkinson's Disease. J Mov Disord. 2015 May;8(2):83-91. doi: 10.14802/jmd.15010. Epub 2015 May 31.</citation>
    <PMID>26090080</PMID>
  </reference>
  <reference>
    <citation>Klepac N, Trkulja V, Relja M, Babic T. Is quality of life in non-demented Parkinson's disease patients related to cognitive performance? A clinic-based cross-sectional study. Eur J Neurol. 2008 Feb;15(2):128-33. doi: 10.1111/j.1468-1331.2007.02011.x.</citation>
    <PMID>18217883</PMID>
  </reference>
  <reference>
    <citation>Lord S, Rochester L, Hetherington V, Allcock LM, Burn D. Executive dysfunction and attention contribute to gait interference in 'off' state Parkinson's Disease. Gait Posture. 2010 Feb;31(2):169-74. doi: 10.1016/j.gaitpost.2009.09.019. Epub 2009 Nov 5.</citation>
    <PMID>19896382</PMID>
  </reference>
  <reference>
    <citation>Middleton FA, Strick PL. Basal ganglia output and cognition: evidence from anatomical, behavioral, and clinical studies. Brain Cogn. 2000 Mar;42(2):183-200. doi: 10.1006/brcg.1999.1099.</citation>
    <PMID>10744919</PMID>
  </reference>
  <reference>
    <citation>Mimura M, Oeda R, Kawamura M. Impaired decision-making in Parkinson's disease. Parkinsonism Relat Disord. 2006 Apr;12(3):169-75. doi: 10.1016/j.parkreldis.2005.12.003. Epub 2006 Mar 23.</citation>
    <PMID>16563850</PMID>
  </reference>
  <reference>
    <citation>Nakano K, Kayahara T, Tsutsumi T, Ushiro H. Neural circuits and functional organization of the striatum. J Neurol. 2000 Sep;247 Suppl 5:V1-15. doi: 10.1007/pl00007778.</citation>
    <PMID>11081799</PMID>
  </reference>
  <reference>
    <citation>Rafal RD, Posner MI, Walker JA, Friedrich FJ. Cognition and the basal ganglia. Separating mental and motor components of performance in Parkinson's disease. Brain. 1984 Dec;107 ( Pt 4):1083-94. doi: 10.1093/brain/107.4.1083.</citation>
    <PMID>6509309</PMID>
  </reference>
  <reference>
    <citation>Williams AE, Arzola GM, Strutt AM, Simpson R, Jankovic J, York MK. Cognitive outcome and reliable change indices two years following bilateral subthalamic nucleus deep brain stimulation. Parkinsonism Relat Disord. 2011 Jun;17(5):321-7. doi: 10.1016/j.parkreldis.2011.01.011. Epub 2011 Feb 11.</citation>
    <PMID>21316292</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>November 10, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>February 11, 2021</last_update_submitted>
  <last_update_submitted_qc>February 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinsons Disease</keyword>
  <keyword>Cognition</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>Yes</sharing_ipd>
    <ipd_description>IPD will be shared only to investigators. It will be deidentified and only accessible through secure, password-protected, encrypted hard drives.</ipd_description>
  </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/NCT02975193
org study id: IRB201601780
secondary id: F30NS111841
nct id: NCT02975193
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cognitive impairment in Parkinson's disease (PD) has far-reaching effects on both motor
      outcomes and quality of life in PD patients. Furthermore, deep brain stimulation (DBS), now
      an evidence-based treatment for certain cases of PD, has the risk of causing deficits in
      multiple areas of cognition.

      As such, the purpose of this study is to understand the neuroanatomical and neurophysiologic
      basis for impaired cognition in PD. The aim is to identify neural correlates of cognition by
      measuring brain signal activity while PD patients are engaged in cognition on a computer.
Study Participants: For this study, the investigators will recruit 75 Parkinson's disease
      (PD) patients that are undergoing deep brain stimulation (DBS) as routine standard of care.

      Screening: For healthy control participants, investigators will approach adults, aged 18-90,
      for possible involvement in our study. Potential participants will be asked if they have ever
      been diagnosed with a movement disorder, psychiatric disorder, or dementia. For PD patients
      undergoing evaluation for DBS, investigators will first consult with their neurologist and
      neurosurgeon. Next, investigators will approach the participant and explain the study.

      PD Participants: As part of the usual DBS process at University of Florida (UF), PD
      participants will be asked to participate in this trial. There are three evaluation time
      points: before surgery, during surgery, and possibly after surgery. Before surgery, the PD
      patients will complete standardized questionnaires and be trained on a computer game to
      assess cognition. During surgery, the participants will play the same computer game while
      brain signals are recorded. When the patients return to University of Florida for DBS
      programming visits within 48 months after surgery, they will repeat the standardized
      questionnaires and computer game once again.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in behavioral performance
time frame: Baseline, before surgery, during surgery, and up to 2 years after surgery
description: Behavioral performance will be assessed by the computer game that assess cognition. All computer games used in this study will have a similar form. The computer will record responses to each trial during the computer game.
measure: Change in Score on Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS)
time frame: Baseline, before surgery, during surgery, and up to 2 years after surgery
description: Assess the scores from a standard clinical questionnaire called QUIP-RS. Scores range from 0 to 112.
measure: Local field potential brain signal
time frame: At time of surgery
description: Measuring Brain signal while Parkinson's disease patients play a computer game during surgery. Local field potential is measured in Hertz (Hz)
arm group label: Control group
arm group type: Active Comparator
description: Healthy adults ages 18-90 without movement disorders, psychiatric disorders, or dementia. They will complete computer games and questionnaires at one time point.
Specific interventions: Computer task assessing cognition, Impulsive-Compulsive Disorders in Parkinson's Disease, Montreal Cognitive Assessment
arm group label: Parkinson's disease group with DBS
arm group type: Active Comparator
description: Parkinson's disease patients who have elected to receive DBS for treatment of their side effects of PD consent to complete computer games and questionnaires at baseline, computer games during deep brain stimulation, and computer games and questionnaires up to 2 years after surgery.
Specific interventions: Computer task assessing cognition, Impulsive-Compulsive Disorders in Parkinson's Disease, Montreal Cognitive Assessment
intervention type: Behavioral
intervention name: Computer task assessing cognition
description: Participants will complete a short computer game to assess cognition.
arm group label: Control group
arm group label: Parkinson's disease group with DBS
intervention type: Behavioral
intervention name: Impulsive-Compulsive Disorders in Parkinson's Disease
description: Standard clinical questionnaire
arm group label: Control group
arm group label: Parkinson's disease group with DBS
other name: QUIP-RS
intervention type: Procedure
intervention name: Deep Brain Stimulation Surgery
description: DBS surgery for the implantation of electrodes for the treatment of motor disorders.
arm group label: Parkinson's disease group with DBS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Aysegul Gunduz, PhD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
citation: Allcock LM, Rowan EN, Steen IN, Wesnes K, Kenny RA, Burn DJ. Impaired attention predicts falling in Parkinson's disease. Parkinsonism Relat Disord. 2009 Feb;15(2):110-5. doi: 10.1016/j.parkreldis.2008.03.010. Epub 2008 May 19.
PMID: 18487069
citation: Awh E, Vogel EK, Oh SH. Interactions between attention and working memory. Neuroscience. 2006 Apr 28;139(1):201-8. doi: 10.1016/j.neuroscience.2005.08.023. Epub 2005 Dec 1.
PMID: 16324792
citation: Baunez C, Lardeux S. Frontal cortex-like functions of the subthalamic nucleus. Front Syst Neurosci. 2011 Oct 11;5:83. doi: 10.3389/fnsys.2011.00083. eCollection 2011.
PMID: 22013416
citation: Filoteo JV, Delis DC, Salmon DP, Demadura T, Roman MJ, Shults CW. An examination of the nature of attentional deficits in patients with Parkinson's disease: evidence from a spatial orienting task. J Int Neuropsychol Soc. 1997 Jul;3(4):337-47.
PMID: 9260443
citation: Gabrieli, J. D., Singh, J., Stebbins, G. T., & Goetz, C. G. (1996). Reduced working memory span in Parkinson's disease: Evidence for the role of frontostriatal system in working and strategic memory. Neuropsychology, 10(3), 322.
citation: Henry JD, Crawford JR. Verbal fluency deficits in Parkinson's disease: a meta-analysis. J Int Neuropsychol Soc. 2004 Jul;10(4):608-22. doi: 10.1017/S1355617704104141.
PMID: 15327739
citation: Itti L, Koch C. Computational modelling of visual attention. Nat Rev Neurosci. 2001 Mar;2(3):194-203. doi: 10.1038/35058500.
PMID: 11256080
citation: Jahanshahi M, Ardouin CM, Brown RG, Rothwell JC, Obeso J, Albanese A, Rodriguez-Oroz MC, Moro E, Benabid AL, Pollak P, Limousin-Dowsey P. The impact of deep brain stimulation on executive function in Parkinson's disease. Brain. 2000 Jun;123 ( Pt 6):1142-54. doi: 10.1093/brain/123.6.1142.
PMID: 10825353
citation: Kim HJ, Jeon BS, Paek SH. Nonmotor Symptoms and Subthalamic Deep Brain Stimulation in Parkinson's Disease. J Mov Disord. 2015 May;8(2):83-91. doi: 10.14802/jmd.15010. Epub 2015 May 31.
PMID: 26090080
citation: Klepac N, Trkulja V, Relja M, Babic T. Is quality of life in non-demented Parkinson's disease patients related to cognitive performance? A clinic-based cross-sectional study. Eur J Neurol. 2008 Feb;15(2):128-33. doi: 10.1111/j.1468-1331.2007.02011.x.
PMID: 18217883
citation: Lord S, Rochester L, Hetherington V, Allcock LM, Burn D. Executive dysfunction and attention contribute to gait interference in 'off' state Parkinson's Disease. Gait Posture. 2010 Feb;31(2):169-74. doi: 10.1016/j.gaitpost.2009.09.019. Epub 2009 Nov 5.
PMID: 19896382
citation: Middleton FA, Strick PL. Basal ganglia output and cognition: evidence from anatomical, behavioral, and clinical studies. Brain Cogn. 2000 Mar;42(2):183-200. doi: 10.1006/brcg.1999.1099.
PMID: 10744919
citation: Mimura M, Oeda R, Kawamura M. Impaired decision-making in Parkinson's disease. Parkinsonism Relat Disord. 2006 Apr;12(3):169-75. doi: 10.1016/j.parkreldis.2005.12.003. Epub 2006 Mar 23.
PMID: 16563850
citation: Nakano K, Kayahara T, Tsutsumi T, Ushiro H. Neural circuits and functional organization of the striatum. J Neurol. 2000 Sep;247 Suppl 5:V1-15. doi: 10.1007/pl00007778.
PMID: 11081799
citation: Rafal RD, Posner MI, Walker JA, Friedrich FJ. Cognition and the basal ganglia. Separating mental and motor components of performance in Parkinson's disease. Brain. 1984 Dec;107 ( Pt 4):1083-94. doi: 10.1093/brain/107.4.1083.
PMID: 6509309
citation: Williams AE, Arzola GM, Strutt AM, Simpson R, Jankovic J, York MK. Cognitive outcome and reliable change indices two years following bilateral subthalamic nucleus deep brain stimulation. Parkinsonism Relat Disord. 2011 Jun;17(5):321-7. doi: 10.1016/j.parkreldis.2011.01.011. Epub 2011 Feb 11.
PMID: 21316292
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: Yes
ipd description: IPD will be shared only to investigators. It will be deidentified and only accessible through secure, password-protected, encrypted hard drives.