<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/NCT03756584</url>
  </required_header>
  <id_info>
    <org_study_id>1-ZVN9</org_study_id>
    <nct_id>NCT03756584</nct_id>
  </id_info>
  <brief_title>Probing TBS-induced Neural Plasticity and Associated Effects on Learning</brief_title>
  <official_title>Probing TBS-induced Neural Plasticity and Associated Effects on Learning</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr Georg Kranz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hong Kong Polytechnic 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>
      Recent animal research indicates that excitatory brain stimulation opens a time window of&#xD;
      increased neural plasticity that permits remodeling of neural representations. Repetitive&#xD;
      transcranial magnetic stimulation (rTMS) may thus facilitate learning of new associations by&#xD;
      reducing proactive interference but human research is missing. Therefore, it is the aim of&#xD;
      this study to investigate the effects of intermittent theta-burst stimulation (iTBS), a&#xD;
      potent form of excitatory brain stimulation, on associative memory. Twenty right handed&#xD;
      healthy participants will receive 3 minutes of iTBS or sham stimulation of the left lateral&#xD;
      parietal cortex after memorizing a set of 20 face-word associations. Recall capacity will be&#xD;
      tested directly before and after stimulation. Participants will then learn a new combination&#xD;
      of associations using the same set of stimuli, followed by an evaluation of their recall&#xD;
      capacity. It is hypothesized that iTBS compared to sham stimulation will reduce recall&#xD;
      capacity directly after the stimulation but increase recall capacity of the newly learned&#xD;
      associations due to reduced proactive interference. This study may not only pave the way&#xD;
      towards a new understanding of the mechanism of action of brain stimulation, but can also&#xD;
      help in developing new treatment strategies for neuropsychiatric disorders.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 3, 2019</start_date>
  <completion_date type="Actual">December 3, 2020</completion_date>
  <primary_completion_date type="Actual">December 3, 2020</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-blind parallel-group crossover design</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in recall capacity</measure>
    <time_frame>Change from baseline to directly after stimulation (~6 min after baseline)</time_frame>
    <description>Change in the number of correct associations of a face-word association memory test</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Intermittent theta-burst stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>iTBS will be performed on the left lateral parietal cortex</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>iTBS will be performed on the vertex</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Theta-burst stimulation</intervention_name>
    <description>iTBS comprises 3-pulse 50-Hz bursts, applied every 200 ms (at 5 Hz) as described previously (Huang, Edwards et al. 2005) and consists of 2-second trains with an inter-train-interval of 8 seconds. We will repeat trains (30 pulses; 10 bursts) for 20 times to reach a total number of 600 pulses per session (3x10x20)</description>
    <arm_group_label>Control stimulation</arm_group_label>
    <arm_group_label>Intermittent theta-burst stimulation</arm_group_label>
    <other_name>Transcranial Magnetic Stimulation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  education level of primary six or above&#xD;
&#xD;
          -  right-handedness&#xD;
&#xD;
          -  normal or corrected-to-normal vision&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  seizures in medical history&#xD;
&#xD;
          -  current or past psychiatric disorders or severe internal or neurological illness&#xD;
&#xD;
          -  common TMS exclusion criteria&#xD;
&#xD;
          -  substance abuse or dependence&#xD;
&#xD;
          -  intake of medication that is known to affect the excitation threshold&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Georg S Kranz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Rehabilitation Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Hong Kong Polytechnic University</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>November 22, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>August 16, 2021</last_update_submitted>
  <last_update_submitted_qc>August 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>The Hong Kong Polytechnic University</investigator_affiliation>
    <investigator_full_name>Dr Georg Kranz</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Behavioral data may be shared with other researchers</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/NCT03756584
org study id: 1-ZVN9
nct id: NCT03756584
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Recent animal research indicates that excitatory brain stimulation opens a time window of
      increased neural plasticity that permits remodeling of neural representations. Repetitive
      transcranial magnetic stimulation (rTMS) may thus facilitate learning of new associations by
      reducing proactive interference but human research is missing. Therefore, it is the aim of
      this study to investigate the effects of intermittent theta-burst stimulation (iTBS), a
      potent form of excitatory brain stimulation, on associative memory. Twenty right handed
      healthy participants will receive 3 minutes of iTBS or sham stimulation of the left lateral
      parietal cortex after memorizing a set of 20 face-word associations. Recall capacity will be
      tested directly before and after stimulation. Participants will then learn a new combination
      of associations using the same set of stimuli, followed by an evaluation of their recall
      capacity. It is hypothesized that iTBS compared to sham stimulation will reduce recall
      capacity directly after the stimulation but increase recall capacity of the newly learned
      associations due to reduced proactive interference. This study may not only pave the way
      towards a new understanding of the mechanism of action of brain stimulation, but can also
      help in developing new treatment strategies for neuropsychiatric disorders.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: single-blind parallel-group crossover design
primary purpose: Basic Science
masking: Double (Participant, Outcomes Assessor)
measure: Change in recall capacity
time frame: Change from baseline to directly after stimulation (~6 min after baseline)
description: Change in the number of correct associations of a face-word association memory test
arm group label: Intermittent theta-burst stimulation
arm group type: Experimental
description: iTBS will be performed on the left lateral parietal cortex
arm group label: Control stimulation
arm group type: Active Comparator
description: iTBS will be performed on the vertex
intervention type: Device
intervention name: Theta-burst stimulation
description: iTBS comprises 3-pulse 50-Hz bursts, applied every 200 ms (at 5 Hz) as described previously (Huang, Edwards et al. 2005) and consists of 2-second trains with an inter-train-interval of 8 seconds. We will repeat trains (30 pulses; 10 bursts) for 20 times to reach a total number of 600 pulses per session (3x10x20)
arm group label: Control stimulation
arm group label: Intermittent theta-burst stimulation
other name: Transcranial Magnetic Stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Georg S Kranz, PhD
role: Principal Investigator
affiliation: Department of Rehabilitation Sciences
facility: 
country: Hong Kong
responsible party type: Sponsor-Investigator
investigator affiliation: The Hong Kong Polytechnic University
investigator full name: Dr Georg Kranz
investigator title: Principal Investigator
sharing ipd: No
ipd description: Behavioral data may be shared with other researchers