<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/NCT03777137</url>
  </required_header>
  <id_info>
    <org_study_id>NA_00084600</org_study_id>
    <nct_id>NCT03777137</nct_id>
  </id_info>
  <brief_title>The Effect of Transcutaneous Magnetic Stimulation on Acute Pain.</brief_title>
  <official_title>Investigation of the Effect of Transcranial Magnetic Stimulation of Several Sites in the Brain Upon Experimental Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Maryland, College Park</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</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>
      This is a single institution, single-blinded, long-term exploratory study using participant&#xD;
      as his/her own control to evaluate and compare the potential analgesic effect on experimental&#xD;
      heat pain of Transcutaneous Magnetic Stimulation (TMS). TMS will be delivered by a&#xD;
      commercially available device (Rapid2, Magstim Corp) at three different cortical target sites&#xD;
      and one sham target site in healthy participants 18-88 years of age. The quantitative&#xD;
      evaluation measure is the change in the painful heat threshold Quantitative Sensory Testing&#xD;
      (QST) of thresholds for cutaneous heat stimuli before and after TMS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After subjects contact the office to express interest in being involved with this protocol,&#xD;
      subjects will take the telephone screening questionnaire. Those who meet inclusion criteria&#xD;
      with no exclusions will come for first visit. At this visit, subjects will discuss and sign&#xD;
      the consent form, and have a one sequence MRI scan which is used to localize sites in the&#xD;
      brain to be stimulated with TMS.&#xD;
&#xD;
      The subjects will then have four visits at intervals of two weeks; each visit will have TMS&#xD;
      intervention designated (SITE1), (SITE2), (SITE3), and (SITE4). TMS will be applied each of&#xD;
      four sites (SITE1, SITE2, SITE3, and SITE4) which will be randomly assigned among stimulation&#xD;
      sites Medial Frontal (MF), Dorsolateral Frontal (DL), Primary Motor Cortex (M1 and superior&#xD;
      Interparietal sulcus (Sham) and counterbalanced across subjects (see Diagram below).&#xD;
&#xD;
      During each of visits 2 to 5, the participant will undergo baseline Quantitative Sensory&#xD;
      Testing (QST), followed by TMS stimulation and then by repeat QST. QST will consist of pain&#xD;
      thresholds for cutaneous hot stimuli. Visits 2 through 5 will last for approximately 1 hour&#xD;
      each and will occur at two-week intervals. The total study duration will be 50 days for each&#xD;
      subject. Study enrollment will last for three years and total study duration will be four&#xD;
      years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Expired in the IRB&#xD;
  </why_stopped>
  <start_date type="Anticipated">October 1, 2021</start_date>
  <completion_date type="Anticipated">July 1, 2027</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2027</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Contact Heat Pain Temperature Threshold Change</measure>
    <time_frame>Entire duration of study, approximately five years</time_frame>
    <description>The contact heat thermal thermode will be used to measure heat pain thresholds (in degrees centigrade) before and after each stimulation site.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Pain Perception</condition>
  <arm_group>
    <arm_group_label>TMS during heat pain stimuli</arm_group_label>
    <description>This is a single institution, single-blinded, long-term exploratory study using participant as his/her own control to evaluate and compare the analgesic effect of experimental heat pain of TMS during early versus late times on a vigilance behaviors toward pain (CPT, Continuous Performance Task). Vigilance behaviors include errors, reaction times and activation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TMS (Rapid2, Magstim Corp)</intervention_name>
    <description>Volunteers will take a telephone screening questionnaire and those meeting inclusion criteria will attend their first visit. Those signing the consent will have a T1 weighted MRI scan to localize sites in the brain to be stimulated with TMS. The subjects will then have four visits at intervals of two weeks; each visit will have a TMS intervention including SITE1, SITE2, SITE3, and SITE4. The sequence of the testing TMS four different visits (SITE1 to SITE4) will be randomly assigned among stimulation sites Medial Frontal (MF), Dorsal Lateral Frontal (DL), Primary motor cortex (M1) and Interparietal Sulcus (Sham) and counterbalanced across subjects (see Diagram below). During each of visits 2 to 5, each participant will undergo baseline Quantitative Sensory Testing (QST), followed by a TMS intervention, and then by repeat QST. QST will consist of pain thresholds for contact heat.</description>
    <arm_group_label>TMS during heat pain stimuli</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will include healthy men and women between 18 and 80 years of age with no history&#xD;
        or family history of seizures. In addition, subjects cannot be taking pro-epileptic&#xD;
        medications or have metal objects in the head except the mouth, as described in the&#xD;
        telephone screening questionnaire.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy man or woman 18-80 years of age;&#xD;
&#xD;
          -  Possess the ability to understand study procedures and comply with them for the entire&#xD;
             length of the study;&#xD;
&#xD;
          -  Women of childbearing age must use contraception for duration of study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of diagnosis of heart disease, increased intracranial pressure, or structural&#xD;
             abnormalities of the brain (e.g. tumor);&#xD;
&#xD;
          -  History of epilepsy, seizure disorder, neurologic disease, cranial trauma or head&#xD;
             surgery, or implanted hardware (including cardiac pacemakers, cardiac lines,&#xD;
             medication pumps, or stimulators);&#xD;
&#xD;
          -  Family history of seizures;&#xD;
&#xD;
          -  Presence of metal anywhere deep to or on the skull (excluding the mouth);&#xD;
&#xD;
          -  Any current or recent (&lt;6 weeks) or planned (within duration of study period) use of&#xD;
             any of the following medications: imipramine, amitriptyline, doxepin, nortriptyline,&#xD;
             maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir,&#xD;
             amphetamines, ketamine, gamma-hydroxybutyrate (GHB), and theophylline;&#xD;
&#xD;
          -  History of peripheral neuropathy, e.g. Diabetic Neuropathy;&#xD;
&#xD;
          -  Women who are pregnant or women of childbearing capacity who may become pregnant (i.e.&#xD;
             not using contraception);&#xD;
&#xD;
          -  Volunteers with communication disorders or non-English speakers;&#xD;
&#xD;
          -  Current drug or alcohol use or dependence that, in the opinion of the investigators,&#xD;
             would interfere with adherence to study requirements.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frederick Lenz</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Neurosurgery, JHU</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopkiins Functional Neurosurgery Lab</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>. Lenz FA, Casey KL, Jones EG, Willis WD, The human pain system: experimental and clinical perspectives. Cambridge, UK ; New York: Cambridge University Press; 2010.</citation>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>October 7, 2021</last_update_submitted>
  <last_update_submitted_qc>October 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Brain network for pain</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>This data may be shared with other investigators in Baltimore studying pain perception by techniques including brain imaging or psychophysics.</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/NCT03777137
org study id: NA_00084600
nct id: NCT03777137
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a single institution, single-blinded, long-term exploratory study using participant
      as his/her own control to evaluate and compare the potential analgesic effect on experimental
      heat pain of Transcutaneous Magnetic Stimulation (TMS). TMS will be delivered by a
      commercially available device (Rapid2, Magstim Corp) at three different cortical target sites
      and one sham target site in healthy participants 18-88 years of age. The quantitative
      evaluation measure is the change in the painful heat threshold Quantitative Sensory Testing
      (QST) of thresholds for cutaneous heat stimuli before and after TMS.
After subjects contact the office to express interest in being involved with this protocol,
      subjects will take the telephone screening questionnaire. Those who meet inclusion criteria
      with no exclusions will come for first visit. At this visit, subjects will discuss and sign
      the consent form, and have a one sequence MRI scan which is used to localize sites in the
      brain to be stimulated with TMS.

      The subjects will then have four visits at intervals of two weeks; each visit will have TMS
      intervention designated (SITE1), (SITE2), (SITE3), and (SITE4). TMS will be applied each of
      four sites (SITE1, SITE2, SITE3, and SITE4) which will be randomly assigned among stimulation
      sites Medial Frontal (MF), Dorsolateral Frontal (DL), Primary Motor Cortex (M1 and superior
      Interparietal sulcus (Sham) and counterbalanced across subjects (see Diagram below).

      During each of visits 2 to 5, the participant will undergo baseline Quantitative Sensory
      Testing (QST), followed by TMS stimulation and then by repeat QST. QST will consist of pain
      thresholds for cutaneous hot stimuli. Visits 2 through 5 will last for approximately 1 hour
      each and will occur at two-week intervals. The total study duration will be 50 days for each
      subject. Study enrollment will last for three years and total study duration will be four
      years.
observational model: Other
time perspective: Prospective
measure: Contact Heat Pain Temperature Threshold Change
time frame: Entire duration of study, approximately five years
description: The contact heat thermal thermode will be used to measure heat pain thresholds (in degrees centigrade) before and after each stimulation site.
arm group label: TMS during heat pain stimuli
description: This is a single institution, single-blinded, long-term exploratory study using participant as his/her own control to evaluate and compare the analgesic effect of experimental heat pain of TMS during early versus late times on a vigilance behaviors toward pain (CPT, Continuous Performance Task). Vigilance behaviors include errors, reaction times and activation.
intervention type: Behavioral
intervention name: TMS (Rapid2, Magstim Corp)
description: Volunteers will take a telephone screening questionnaire and those meeting inclusion criteria will attend their first visit. Those signing the consent will have a T1 weighted MRI scan to localize sites in the brain to be stimulated with TMS. The subjects will then have four visits at intervals of two weeks; each visit will have a TMS intervention including SITE1, SITE2, SITE3, and SITE4. The sequence of the testing TMS four different visits (SITE1 to SITE4) will be randomly assigned among stimulation sites Medial Frontal (MF), Dorsal Lateral Frontal (DL), Primary motor cortex (M1) and Interparietal Sulcus (Sham) and counterbalanced across subjects (see Diagram below). During each of visits 2 to 5, each participant will undergo baseline Quantitative Sensory Testing (QST), followed by a TMS intervention, and then by repeat QST. QST will consist of pain thresholds for contact heat.
arm group label: TMS during heat pain stimuli
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Frederick Lenz
role: Principal Investigator
affiliation: Department of Neurosurgery, JHU
facility: 
country: United States
citation: . Lenz FA, Casey KL, Jones EG, Willis WD, The human pain system: experimental and clinical perspectives. Cambridge, UK ; New York: Cambridge University Press; 2010.
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: This data may be shared with other investigators in Baltimore studying pain perception by techniques including brain imaging or psychophysics.