<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/NCT03293316</url>
  </required_header>
  <id_info>
    <org_study_id>C2-2014-033</org_study_id>
    <nct_id>NCT03293316</nct_id>
  </id_info>
  <brief_title>Using Electroencephalography (EEG) and Transcranial Current Stimulation (tCS) to Study and Modulate Cognition Study</brief_title>
  <official_title>Using Electroencephalography (EEG) and Transcranial Current Stimulation (tCS) to Study and Modulate Cognition Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oxford</source>
  <brief_summary>
    <textblock>
      Inter-individual variability in responsiveness to interventions poses great challenges for&#xD;
      translational neuroscience, and health care in general. The investigations sought to examine&#xD;
      the potential for high-frequency transcranial random noise stimulation (tRNS) to modulate&#xD;
      sustained attention in a manner that was informed by individual differences in EEG indices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inter-individual variability in responsiveness to interventions poses great challenges for&#xD;
      translational neuroscience, and health care in general. Reliable and cost- effective&#xD;
      screening procedures that can identify individuals who are more likely to benefit from an&#xD;
      intervention could have substantial real-world benefits. Here, the investigators sought to&#xD;
      examine the potential for high-frequency transcranial random noise stimulation (tRNS) to&#xD;
      modulate sustained attention in a manner that was informed by individual differences in a&#xD;
      well-studied electrocortical marker, spontaneous theta/beta ratio. The investigators&#xD;
      hypothesized that individuals with relatively high theta/beta ratios, putatively reflecting&#xD;
      suboptimal cortical arousal, would be more likely to benefit from the gains in cortical&#xD;
      excitability afforded by tRNS. Seventy-two young healthy adults were administered 1mA, 2mA&#xD;
      and sham tRNS in a double-blind, randomised, cross-over manner, while they performed a&#xD;
      continuous monitoring paradigm. Electroencephalography was acquired before and after each&#xD;
      stimulation condition.&#xD;
&#xD;
      This approach may constitute a feasible means of using individual differences in&#xD;
      neurophysiology to inform predictions about outcomes from targeted cognitive interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2015</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Randomized Double-Blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Electroencephalography</measure>
    <time_frame>4 minutes</time_frame>
    <description>Voltage readings from the scalp</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sustained Attention performance</measure>
    <time_frame>20 minutes</time_frame>
    <description>Sustained Attention performance was defined as response time variability on a continuous monitoring paradigm</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Inter-individual Variability</condition>
  <arm_group>
    <arm_group_label>Sham Transcranial Random Noise Stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The sham tRNS condition involves 30 seconds of 1.5 mA tRNS, with a ramping period of 30 seconds at the onset and offset. This procedure ensures that, in both the Active and Sham conditions, participants experience the sensations associated with the onset of transcranial electrical stimulation (e.g., tingling sensation)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1mA Transcranial Random Noise Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The 1mA tRNS condition consists of 1 mA peak-to-peak (-.5 mA to .5 mA) high frequency noise (100-500 Hz), with amplitude values that are normally distributed and have a mean of zero. The stimulation is delivered for 20 minutes, with a ramping period of 30 seconds at the onset and offset.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2mA Transcranial Random Noise Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The only factor that varies for the 2mA tRNS condition is that the high frequency noise has a peak-to-peak of -1 mA to 1mA as opposed to -.5 mA to .5 mA. Again, the stimulation is delivered for 20 minutes, with a ramping period of 30 seconds at the onset and offset.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial Random Noise Stimulation</intervention_name>
    <description>The transcranial random noise stimulation was delivered using a StarStim device (Neuroelectrics®, Barcelona, Spain). The electrodes were encased in a pair of saline-soaked sponges (25 cm2 ), and were secured within a Neurolectrics EEG cap over right DLPFC (F4) and right IPL (P4), according to the 10-20 international EEG system. Other details are stated under the 'intervention arm' descriptions.</description>
    <arm_group_label>1mA Transcranial Random Noise Stimulation</arm_group_label>
    <arm_group_label>2mA Transcranial Random Noise Stimulation</arm_group_label>
    <arm_group_label>Sham Transcranial Random Noise Stimulation</arm_group_label>
    <other_name>Starstim; Neuroelectrics</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        - Aged 18-35 years&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Left-handedness&#xD;
&#xD;
          -  Visual impairment&#xD;
&#xD;
          -  History of fainting,&#xD;
&#xD;
          -  History of neurological or psychiatric illness,&#xD;
&#xD;
          -  Neurological insult&#xD;
&#xD;
          -  Drug or alcohol abuse&#xD;
&#xD;
          -  Reporting current use of anti- psychotic or anti-depressant medications&#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>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>September 29, 2017</last_update_submitted>
  <last_update_submitted_qc>September 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Transcranial electrical stimulation; random noise;</keyword>
  <keyword>cognitive interventions; electroencephalography;</keyword>
  <keyword>inter-individual variability; stochastic resonance;</keyword>
  <pending_results>
    <submitted>September 15, 2020</submitted>
    <returned>October 8, 2020</returned>
    <submitted>October 19, 2020</submitted>
    <returned>November 11, 2020</returned>
  </pending_results>
  <!-- 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/NCT03293316
org study id: C2-2014-033
nct id: NCT03293316
lead sponsor: 
Inter-individual variability in responsiveness to interventions poses great challenges for
      translational neuroscience, and health care in general. The investigations sought to examine
      the potential for high-frequency transcranial random noise stimulation (tRNS) to modulate
      sustained attention in a manner that was informed by individual differences in EEG indices.
Inter-individual variability in responsiveness to interventions poses great challenges for
      translational neuroscience, and health care in general. Reliable and cost- effective
      screening procedures that can identify individuals who are more likely to benefit from an
      intervention could have substantial real-world benefits. Here, the investigators sought to
      examine the potential for high-frequency transcranial random noise stimulation (tRNS) to
      modulate sustained attention in a manner that was informed by individual differences in a
      well-studied electrocortical marker, spontaneous theta/beta ratio. The investigators
      hypothesized that individuals with relatively high theta/beta ratios, putatively reflecting
      suboptimal cortical arousal, would be more likely to benefit from the gains in cortical
      excitability afforded by tRNS. Seventy-two young healthy adults were administered 1mA, 2mA
      and sham tRNS in a double-blind, randomised, cross-over manner, while they performed a
      continuous monitoring paradigm. Electroencephalography was acquired before and after each
      stimulation condition.

      This approach may constitute a feasible means of using individual differences in
      neurophysiology to inform predictions about outcomes from targeted cognitive interventions.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
masking description: Randomized Double-Blind
measure: Electroencephalography
time frame: 4 minutes
description: Voltage readings from the scalp
measure: Sustained Attention performance
time frame: 20 minutes
description: Sustained Attention performance was defined as response time variability on a continuous monitoring paradigm
arm group label: Sham Transcranial Random Noise Stimulation
arm group type: Sham Comparator
description: The sham tRNS condition involves 30 seconds of 1.5 mA tRNS, with a ramping period of 30 seconds at the onset and offset. This procedure ensures that, in both the Active and Sham conditions, participants experience the sensations associated with the onset of transcranial electrical stimulation (e.g., tingling sensation)
arm group label: 1mA Transcranial Random Noise Stimulation
arm group type: Experimental
description: The 1mA tRNS condition consists of 1 mA peak-to-peak (-.5 mA to .5 mA) high frequency noise (100-500 Hz), with amplitude values that are normally distributed and have a mean of zero. The stimulation is delivered for 20 minutes, with a ramping period of 30 seconds at the onset and offset.
arm group label: 2mA Transcranial Random Noise Stimulation
arm group type: Experimental
description: The only factor that varies for the 2mA tRNS condition is that the high frequency noise has a peak-to-peak of -1 mA to 1mA as opposed to -.5 mA to .5 mA. Again, the stimulation is delivered for 20 minutes, with a ramping period of 30 seconds at the onset and offset.
intervention type: Device
intervention name: Transcranial Random Noise Stimulation
description: The transcranial random noise stimulation was delivered using a StarStim device (Neuroelectrics®, Barcelona, Spain). The electrodes were encased in a pair of saline-soaked sponges (25 cm2 ), and were secured within a Neurolectrics EEG cap over right DLPFC (F4) and right IPL (P4), according to the 10-20 international EEG system. Other details are stated under the 'intervention arm' descriptions.
arm group label: 1mA Transcranial Random Noise Stimulation
arm group label: 2mA Transcranial Random Noise Stimulation
arm group label: Sham Transcranial Random Noise Stimulation
other name: Starstim; Neuroelectrics
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
submitted: September 15, 2020
returned: October 8, 2020
submitted: October 19, 2020
returned: November 11, 2020