<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/NCT02235792</url>
  </required_header>
  <id_info>
    <org_study_id>13-002360</org_study_id>
    <nct_id>NCT02235792</nct_id>
  </id_info>
  <brief_title>High Frequency Oscillations in Neurologic Disease</brief_title>
  <official_title>Chronically-recorded Deep Brain Nuclei/Hippocampal High Frequency Oscillations (HFOs) as Biomarkers of Neurologic Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to evaluate the high-frequency range deep brain oscillations (HFO) as&#xD;
      pathologic markers in patients undergoing deep brain stimulation for epilepsy or Parkinson&#xD;
      disease. Newly developed technology allows for the chronic recording of these brain signals&#xD;
      at the same time as clinical stimulation is occuring. We will learn both whether these HFO&#xD;
      correlate with disease activity and whether the HFO change in response to ongoing stimulation&#xD;
      (potentially giving insight into the underlying mechanism of action of DBS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is designed to evaluate the high-frequency range deep brain oscillations (HFO) as&#xD;
      pathologic markers in patients undergoing deep brain stimulation for epilepsy or Parkinson&#xD;
      disease. Newly developed technology allows for the chronic recording of these brain signals&#xD;
      at the same time as clinical stimulation is occuring. We will learn both whether these HFO&#xD;
      correlate with disease activity and whether the HFO change in response to ongoing stimulation&#xD;
      (potentially giving insight into the underlying mechanism of action of DBS). Study&#xD;
      participants will undergo DBS in the same way as is usually done but will receive this newer&#xD;
      battery with ability to record brain signals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">November 20, 2020</completion_date>
  <primary_completion_date type="Actual">November 20, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Degree of correlation of recorded neural signatures with disease severity as determined by regression analysis</measure>
    <time_frame>26 weeks post deep brain stimulator implantation</time_frame>
    <description>Regression analysis will be performed using the measures of clinical disease severity as the independent variables and the various HFO measurement conditions/parameters as dependent variables.&#xD;
HFO parameters to be analyzed will include: 1) total power within each recorded band and 2) frequency distribution as defined by the ratio of power within the higher HFO frequency band versus the lower HFO frequency band.&#xD;
Clinical disease severity will be determined by: 1) Unified Parkinson's Disease Rating Scale (UPDRS III) score in each of the various conditions for Parkinson Disease (PD) subjects, 2) motor diaries linked with each visit for PD subjects, and 3) seizure counts from the 4 weeks of seizure diary preceding each visit for epilepsy subjects.&#xD;
(Note: UPDRS is a rating scale used to follow the longitudinal course of Parkinson's disease. Part III is a clinician-scored monitored motor evaluation.)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Parkinson</condition>
  <condition>Epilepsy</condition>
  <arm_group>
    <arm_group_label>Deep Brain Stimulation 37604 Activa PC+S</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will undergo DBS using the 37604 Activa PC+S device (single arm study).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Activa PC+S</intervention_name>
    <description>The model 37604 Activa PC+S system is a multiprogrammable device that both delivers electrical stimulation and records bioelectric data through one or two leads implanted in the brain.</description>
    <arm_group_label>Deep Brain Stimulation 37604 Activa PC+S</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Medically-refractory neurologic disease amenable to therapy with deep brain&#xD;
             stimulation including:&#xD;
&#xD;
               1. Idiopathic Parkinson disease with motor fluctuation, dyskinesia, and/or medically&#xD;
                  refractory tremor despite optimal medical management by a movement disorders&#xD;
                  neurologist.&#xD;
&#xD;
                  OR&#xD;
&#xD;
               2. Unilateral or bilateral mesial temporal lobe (hippocampal) epilepsy with complex&#xD;
                  partial, and/or secondarily generalized seizures, that is:&#xD;
&#xD;
                    -  confirmed through a combination of interictal scalp EEG, ictal scalp EEG&#xD;
                       under video monitoring, ictal SPECT scanning, and/or invasive EEG monitoring&#xD;
&#xD;
                    -  disabling seizure counts &gt;2 per month documented over a 3 month period&#xD;
&#xD;
                    -  refractory to at least three antiepileptic drugs given at clinically&#xD;
                       appropriate maintenance doses resulting in therapeutic plasma levels (in&#xD;
                       cases where such levels have been established for that particular drug. Drug&#xD;
                       failures because of side- effects will not be counted toward this total.&#xD;
&#xD;
                    -  determined to have mesial temporal lobe epilepsy that is not amenable to&#xD;
                       resective surgery according to consensus opinion among epileptologists on&#xD;
                       our institution's multidisciplinary Epilepsy Surgery Committee&#xD;
&#xD;
          2. Mayo Clinic Deep Brain Stimulation Committee approval for bilateral deep brain&#xD;
             stimulation therapy obtained on routine clinical grounds and without reference to this&#xD;
             protocol.&#xD;
&#xD;
          3. Age 18 to 75.&#xD;
&#xD;
          4. Ability and willingness to provide informed consent and participate in the study&#xD;
             protocol.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Diagnoses other than those included in #1 above.&#xD;
&#xD;
          2. Comorbid nonepileptic behavioral events or psychogenic movement disorder.&#xD;
&#xD;
          3. Medical contraindications to DBS surgery.&#xD;
&#xD;
          4. Psychiatric comorbidities not under stable medical therapy.&#xD;
&#xD;
          5. Neurodegenerative dementia (cognitive dysfunction resulting from frequent seizure&#xD;
             activity will not be an exclusion criteria).&#xD;
&#xD;
          6. Implanted electronically active medical device with the potential to interfere with&#xD;
             intracranial recordings (ex. pacemaker, automatic implantable cardioverter&#xD;
             defibrillator (AICD), active vagal nerve stimulator).&#xD;
&#xD;
          7. Pregnancy; women of child-bearing potential will be required to commit to using an&#xD;
             effective method of contraception during the entire duration of the trial. If a&#xD;
             subject becomes pregnant despite these precautions, she will be required to report&#xD;
             that to our center within two weeks at which point explantation of the experimental&#xD;
             device would be an option.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bryan Klassen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>April 14, 2022</last_update_submitted>
  <last_update_submitted_qc>April 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Bryan T. Klassen, M.D.</investigator_full_name>
    <investigator_title>Consultant Neurology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nervous System Diseases</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/NCT02235792
org study id: 13-002360
nct id: NCT02235792
lead sponsor: 
has dmc: No
This study is designed to evaluate the high-frequency range deep brain oscillations (HFO) as
      pathologic markers in patients undergoing deep brain stimulation for epilepsy or Parkinson
      disease. Newly developed technology allows for the chronic recording of these brain signals
      at the same time as clinical stimulation is occuring. We will learn both whether these HFO
      correlate with disease activity and whether the HFO change in response to ongoing stimulation
      (potentially giving insight into the underlying mechanism of action of DBS).
This study is designed to evaluate the high-frequency range deep brain oscillations (HFO) as
      pathologic markers in patients undergoing deep brain stimulation for epilepsy or Parkinson
      disease. Newly developed technology allows for the chronic recording of these brain signals
      at the same time as clinical stimulation is occuring. We will learn both whether these HFO
      correlate with disease activity and whether the HFO change in response to ongoing stimulation
      (potentially giving insight into the underlying mechanism of action of DBS). Study
      participants will undergo DBS in the same way as is usually done but will receive this newer
      battery with ability to record brain signals.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Degree of correlation of recorded neural signatures with disease severity as determined by regression analysis
time frame: 26 weeks post deep brain stimulator implantation
description: Regression analysis will be performed using the measures of clinical disease severity as the independent variables and the various HFO measurement conditions/parameters as dependent variables.
HFO parameters to be analyzed will include: 1) total power within each recorded band and 2) frequency distribution as defined by the ratio of power within the higher HFO frequency band versus the lower HFO frequency band.
Clinical disease severity will be determined by: 1) Unified Parkinson's Disease Rating Scale (UPDRS III) score in each of the various conditions for Parkinson Disease (PD) subjects, 2) motor diaries linked with each visit for PD subjects, and 3) seizure counts from the 4 weeks of seizure diary preceding each visit for epilepsy subjects.
(Note: UPDRS is a rating scale used to follow the longitudinal course of Parkinson's disease. Part III is a clinician-scored monitored motor evaluation.)
arm group label: Deep Brain Stimulation 37604 Activa PC+S
arm group type: Experimental
description: All subjects will undergo DBS using the 37604 Activa PC+S device (single arm study).
intervention type: Device
intervention name: Activa PC+S
description: The model 37604 Activa PC+S system is a multiprogrammable device that both delivers electrical stimulation and records bioelectric data through one or two leads implanted in the brain.
arm group label: Deep Brain Stimulation 37604 Activa PC+S
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Bryan Klassen, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Bryan T. Klassen, M.D.
investigator title: Consultant Neurology
mesh term: Nervous System Diseases