xml: <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/NCT06015672</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00112239</org_study_id>
      <nct_id>NCT06015672</nct_id>
    </id_info>
    <brief_title>Accelerated TMS for Focal Hand Dystonia</brief_title>
    <official_title>Duke Accelerated Transcranial Magnetic Stimulation for Focal Hand Dystonia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Duke University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>American Academy of Neurology</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Duke University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study aims to investigate the impact of accelerated transcranial magnetic stimulation&#xD;
        (TMS) on brain function and behavior in patients with focal hand dystonia. Previous research&#xD;
        demonstrated that individualized TMS improved dystonic behavior after one session. Building&#xD;
        on this, the current study administers four TMS sessions in a day, with assessments conducted&#xD;
        on the same day, two weeks, and twelve weeks after each session. The research involves 10&#xD;
        in-person visits and focuses on functional MRI brain scans and writing behavior analysis. The&#xD;
        potential risk of seizures from TMS is mitigated through careful screening, adhering to&#xD;
        safety guidelines. The study's main benefit is enhancing dystonic behavior and deepening the&#xD;
        understanding of brain changes caused by TMS in focal hand dystonia, paving the way for&#xD;
        further advancements in clinical therapy for this condition.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The primary aim of this research is to investigate the impact of transcranial magnetic&#xD;
        stimulation (TMS) on both brain function and behavioral outcomes among individuals suffering&#xD;
        from focal hand dystonia. A preliminary examination of a previous TMS study carried out by&#xD;
        our team revealed that the application of TMS, using personalized, fMRI-guided brain&#xD;
        targeting and interleaved TMS delivery during motor tasks, has the potential to modify brain&#xD;
        activity and ameliorate dystonic behavior after a single session of TMS in patients with&#xD;
        focal hand dystonia. This present study seeks to build upon these promising findings by&#xD;
        administering four TMS sessions in a single day, interspersed with four rest intervals, a&#xD;
        protocol referred to as &quot;accelerated TMS.&quot; The investigation will consist of a total of ten&#xD;
        in-person appointments. Participants with focal hand dystonia will receive accelerated TMS&#xD;
        during three in-person visits. Following each TMS session, participants will evaluate changes&#xD;
        in brain function and behavior. During the assessment visits, individuals will undergo&#xD;
        functional MRI brain scans and engage in writing tasks on an electronic tablet. The principal&#xD;
        risk associated with TMS is the possibility of inducing a seizure. However, this study will&#xD;
        strictly adhere to safety guidelines, utilizing TMS levels that have not previously been&#xD;
        linked to seizures in properly screened individuals. Notably, the dosages of TMS proposed for&#xD;
        use in this study have not caused seizures in healthy volunteers. To further mitigate the&#xD;
        risk of seizures, potential subjects will undergo medical screening for any known factors&#xD;
        that could predispose them to seizures. The primary advantage of this study lies in its&#xD;
        potential to enhance dystonic behavior in patients with focal hand dystonia, while also&#xD;
        deepening our comprehension of the foundational changes in brain function before and after&#xD;
        TMS intervention for focal hand dystonia. The discoveries stemming from this investigation&#xD;
        will pave the way for future research endeavors aimed at advancing brain stimulation as a&#xD;
        viable clinical therapy for focal hand dystonia.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 9, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 9, 2024</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>
      <intervention_model_description>Single-arm crossover study design with subjects receiving TMS at two different intensities and two cortical locations</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>The TMS intensity and cortical location delivered at each TMS visit will be masked</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in behavioral writing measure</measure>
      <time_frame>0 days, 2 weeks, and 12 weeks post-TMS</time_frame>
      <description>Using change in peak accelerations to assess writing behavior</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in brain connectivity in the motor network</measure>
      <time_frame>0 days, 2 weeks and 12 weeks post-TMS</time_frame>
      <description>using functional magnetic resonance imaging of the brain</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Isolated Focal Hand Dystonia</condition>
    <arm_group>
      <arm_group_label>TMS to premotor cortex</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants receive TMS at premotor cortex</description>
    </arm_group>
    <arm_group>
      <arm_group_label>TMS to primary somatosensory cortex</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants received TMS sessions at primary somatosensory cortex</description>
    </arm_group>
    <arm_group>
      <arm_group_label>TMS at low amplitude to primary somatosensory cortex</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Participants receive TMS at a cortical target at smaller amplitude</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Transcranial Magnetic Stimulation (TMS)</intervention_name>
      <description>Participants will experience three accelerated transcranial magnetic stimulation (TMS) sessions, with 12 week (three-months) gap between each session.</description>
      <arm_group_label>TMS at low amplitude to primary somatosensory cortex</arm_group_label>
      <arm_group_label>TMS to premotor cortex</arm_group_label>
      <arm_group_label>TMS to primary somatosensory cortex</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18yrs and older&#xD;
  &#xD;
            -  Diagnosed with isolated focal hand by Neurologist&#xD;
  &#xD;
            -  Right-hand dominant&#xD;
  &#xD;
            -  Must be able to sign an informed consent&#xD;
  &#xD;
            -  Must be literate&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Other neurological movement disorders diagnoses including other types of dystonia,&#xD;
               Parkinsonism, or essential tremor&#xD;
  &#xD;
            -  History of seizure disorder&#xD;
  &#xD;
            -  Concomitant medications are known to decrease seizure threshold&#xD;
  &#xD;
            -  Illicit drug use&#xD;
  &#xD;
            -  No TMS therapy for another indication within one month of this research study&#xD;
  &#xD;
            -  Botulinum toxin injections within 3months of the research study&#xD;
  &#xD;
            -  Medications used for symptom treatment of dystonia including anticholinergic,&#xD;
               benzodiazepines, and muscle relaxants among others within one month of the study&#xD;
  &#xD;
            -  No physical or occupational therapy of the hand within one month of the study&#xD;
  &#xD;
            -  Any contraindications to MRI or TMS&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Noreen Bukhari-Parlakturk, MD PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Duke Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Noreen Bukhari-Parlakturk, MD PhD</last_name>
      <phone>(919) 668-2879</phone>
      <email>movdisres@dm.duke.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Alaa Norain, MBS</last_name>
      <phone>(919) 668-2879</phone>
      <email>movdisres@dm.duke.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Duke University Health System</name>
        <address>
          <city>Durham</city>
          <state>North Carolina</state>
          <zip>27705</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Noreen Bukhari-Parlakturk, MD PhD</last_name>
        <phone>919-668-2879</phone>
        <email>movdisres@dm.duke.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Noreen Bukhari-Parlakturk, Patrick Mulcahey, Michael Lutz, Rabia Ghazi, Ziping Huang, Moritz Dannhauer, Zeynep Simsek, Skylar Groves, Mikaela Lipp, Michael Fei, Tiffany Tran, Eleanor Wood, Lysianne Beynel, Burton Scott, Pichet Termsarasab, Chris Petty, Hussein R Al-Khalidi, James Voyvodic, Lawrence G. Appelbaum, Simon Davis, Andrew Michael, Angel Peterchev, Nicole Calakos. &quot;Functional MRI-guided individualized TMS modifies motor network and reduces writing dysfluency in Focal Hand Dystonia.&quot; Human Brain Mapping Conference. Montreal, Canada. July 22-26, 2023. virtual poster presentation.</citation>
    </reference>
    <reference>
      <citation>Noreen Bukhari-Parlakturk, Patrick Mulcahey, Michael Lutz, Rabia Ghazi, Ziping Huang, Moritz Dannhauer, Zeynep Simsek, Skylar Groves, Mikaela Lipp, Michael Fei, Tiffany Tran, Eleanor Wood, Lysianne Beynel, Burton Scott, Pichet Termsarasab, Chris Petty, Hussein R Al-Khalidi, James Voyvodic, Lawrence G. Appelbaum, Simon Davis, Andrew Michael, Angel Peterchev, Nicole Calakos. &quot;Functional MRI-guided individualized TMS modifies motor network and reduces writing dysfluency in Focal Hand Dystonia.&quot; Samuel Belzberg 6th International Dystonia Symposium. Dublin, Ireland. June 1-3, 2023. poster presentation.</citation>
    </reference>
    <reference>
      <citation>Bukhari-Parlakturk N, Lutz MW, Al-Khalidi HR, Unnithan S, Wang JE, Scott B, Termsarasab P, Appelbaum LG, Calakos N. Suitability of Automated Writing Measures for Clinical Trial Outcome in Writer's Cramp. Mov Disord. 2023 Jan;38(1):123-132. doi: 10.1002/mds.29237. Epub 2022 Oct 13.</citation>
      <PMID>36226903</PMID>
    </reference>
    <reference>
      <citation>Dannhauer M, Huang Z, Beynel L, Wood E, Bukhari-Parlakturk N, Peterchev AV. TAP: targeting and analysis pipeline for optimization and verification of coil placement in transcranial magnetic stimulation. J Neural Eng. 2022 Apr 21;19(2):10.1088/1741-2552/ac63a4. doi: 10.1088/1741-2552/ac63a4.</citation>
      <PMID>35377345</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</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>Dystonia</mesh_term>
      <mesh_term>Dystonic Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06015672
  org study id: Pro00112239
  nct id: NCT06015672
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  This study aims to investigate the impact of accelerated transcranial magnetic stimulation
        (TMS) on brain function and behavior in patients with focal hand dystonia. Previous research
        demonstrated that individualized TMS improved dystonic behavior after one session. Building
        on this, the current study administers four TMS sessions in a day, with assessments conducted
        on the same day, two weeks, and twelve weeks after each session. The research involves 10
        in-person visits and focuses on functional MRI brain scans and writing behavior analysis. The
        potential risk of seizures from TMS is mitigated through careful screening, adhering to
        safety guidelines. The study's main benefit is enhancing dystonic behavior and deepening the
        understanding of brain changes caused by TMS in focal hand dystonia, paving the way for
        further advancements in clinical therapy for this condition.
  The primary aim of this research is to investigate the impact of transcranial magnetic
        stimulation (TMS) on both brain function and behavioral outcomes among individuals suffering
        from focal hand dystonia. A preliminary examination of a previous TMS study carried out by
        our team revealed that the application of TMS, using personalized, fMRI-guided brain
        targeting and interleaved TMS delivery during motor tasks, has the potential to modify brain
        activity and ameliorate dystonic behavior after a single session of TMS in patients with
        focal hand dystonia. This present study seeks to build upon these promising findings by
        administering four TMS sessions in a single day, interspersed with four rest intervals, a
        protocol referred to as "accelerated TMS." The investigation will consist of a total of ten
        in-person appointments. Participants with focal hand dystonia will receive accelerated TMS
        during three in-person visits. Following each TMS session, participants will evaluate changes
        in brain function and behavior. During the assessment visits, individuals will undergo
        functional MRI brain scans and engage in writing tasks on an electronic tablet. The principal
        risk associated with TMS is the possibility of inducing a seizure. However, this study will
        strictly adhere to safety guidelines, utilizing TMS levels that have not previously been
        linked to seizures in properly screened individuals. Notably, the dosages of TMS proposed for
        use in this study have not caused seizures in healthy volunteers. To further mitigate the
        risk of seizures, potential subjects will undergo medical screening for any known factors
        that could predispose them to seizures. The primary advantage of this study lies in its
        potential to enhance dystonic behavior in patients with focal hand dystonia, while also
        deepening our comprehension of the foundational changes in brain function before and after
        TMS intervention for focal hand dystonia. The discoveries stemming from this investigation
        will pave the way for future research endeavors aimed at advancing brain stimulation as a
        viable clinical therapy for focal hand dystonia.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Single-arm crossover study design with subjects receiving TMS at two different intensities and two cortical locations
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: The TMS intensity and cortical location delivered at each TMS visit will be masked
  measure: Change in behavioral writing measure
  time frame: 0 days, 2 weeks, and 12 weeks post-TMS
  description: Using change in peak accelerations to assess writing behavior
  measure: Change in brain connectivity in the motor network
  time frame: 0 days, 2 weeks and 12 weeks post-TMS
  description: using functional magnetic resonance imaging of the brain
  arm group label: TMS to premotor cortex
  arm group type: Active Comparator
  description: Participants receive TMS at premotor cortex
  arm group label: TMS to primary somatosensory cortex
  arm group type: Active Comparator
  description: Participants received TMS sessions at primary somatosensory cortex
  arm group label: TMS at low amplitude to primary somatosensory cortex
  arm group type: Sham Comparator
  description: Participants receive TMS at a cortical target at smaller amplitude
  intervention type: Device
  intervention name: Transcranial Magnetic Stimulation (TMS)
  description: Participants will experience three accelerated transcranial magnetic stimulation (TMS) sessions, with 12 week (three-months) gap between each session.
  arm group label: TMS at low amplitude to primary somatosensory cortex
  arm group label: TMS to premotor cortex
  arm group label: TMS to primary somatosensory cortex
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Noreen Bukhari-Parlakturk, MD PhD
  role: Principal Investigator
  affiliation: Duke Health
  last name: Noreen Bukhari-Parlakturk, MD PhD
  phone: (919) 668-2879
  email: movdisres@dm.duke.edu
  last name: Alaa Norain, MBS
  phone: (919) 668-2879
  email: movdisres@dm.duke.edu
  facility: 
  contact: 
  country: United States
  citation: Noreen Bukhari-Parlakturk, Patrick Mulcahey, Michael Lutz, Rabia Ghazi, Ziping Huang, Moritz Dannhauer, Zeynep Simsek, Skylar Groves, Mikaela Lipp, Michael Fei, Tiffany Tran, Eleanor Wood, Lysianne Beynel, Burton Scott, Pichet Termsarasab, Chris Petty, Hussein R Al-Khalidi, James Voyvodic, Lawrence G. Appelbaum, Simon Davis, Andrew Michael, Angel Peterchev, Nicole Calakos. "Functional MRI-guided individualized TMS modifies motor network and reduces writing dysfluency in Focal Hand Dystonia." Human Brain Mapping Conference. Montreal, Canada. July 22-26, 2023. virtual poster presentation.
  citation: Noreen Bukhari-Parlakturk, Patrick Mulcahey, Michael Lutz, Rabia Ghazi, Ziping Huang, Moritz Dannhauer, Zeynep Simsek, Skylar Groves, Mikaela Lipp, Michael Fei, Tiffany Tran, Eleanor Wood, Lysianne Beynel, Burton Scott, Pichet Termsarasab, Chris Petty, Hussein R Al-Khalidi, James Voyvodic, Lawrence G. Appelbaum, Simon Davis, Andrew Michael, Angel Peterchev, Nicole Calakos. "Functional MRI-guided individualized TMS modifies motor network and reduces writing dysfluency in Focal Hand Dystonia." Samuel Belzberg 6th International Dystonia Symposium. Dublin, Ireland. June 1-3, 2023. poster presentation.
  citation: Bukhari-Parlakturk N, Lutz MW, Al-Khalidi HR, Unnithan S, Wang JE, Scott B, Termsarasab P, Appelbaum LG, Calakos N. Suitability of Automated Writing Measures for Clinical Trial Outcome in Writer's Cramp. Mov Disord. 2023 Jan;38(1):123-132. doi: 10.1002/mds.29237. Epub 2022 Oct 13.
  PMID: 36226903
  citation: Dannhauer M, Huang Z, Beynel L, Wood E, Bukhari-Parlakturk N, Peterchev AV. TAP: targeting and analysis pipeline for optimization and verification of coil placement in transcranial magnetic stimulation. J Neural Eng. 2022 Apr 21;19(2):10.1088/1741-2552/ac63a4. doi: 10.1088/1741-2552/ac63a4.
  PMID: 35377345
  responsible party type: Sponsor
  mesh term: Dystonia
  mesh term: Dystonic Disorders
  sharing ipd: No