<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/NCT03034109</url>
  </required_header>
  <id_info>
    <org_study_id>986244</org_study_id>
    <nct_id>NCT03034109</nct_id>
  </id_info>
  <brief_title>Transcranial Direct Current Stimulation (tDCS) in Post-Stroke Working Memory Deficits</brief_title>
  <acronym>TDCS-PSMWD</acronym>
  <official_title>Transcranial Direct Current Stimulation (tDCS) in Post-Stroke Working Memory Deficits</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stony Brook University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center of Neuromodulation for Rehabilitation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Stony Brook University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test the effects of tDCS (Transcranial Direct Current&#xD;
      Stimulation) on stroke patients with working memory problems.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After having a stroke, people often have trouble remembering to do something, solving&#xD;
      problems, or following conversations. They can also have trouble concentrating, following&#xD;
      instructions, and multitasking. These can all due to the stroke affecting a brain function&#xD;
      called &quot;working memory&quot;. Working memory is defined as the ability to hold a thought in one's&#xD;
      mind for a few seconds in order to remember a task or solve a problem. People have difficulty&#xD;
      returning to their normal lives because of these working memory problems. Currently, there no&#xD;
      proven medical treatments for working memory problems.&#xD;
&#xD;
      Transcranial direct current stimulation (tDCS) is a painless, noninvasive brain stimulation&#xD;
      technique that has been shown in some studies to improve working memory in healthy subjects.&#xD;
      TDCS involves sending a weak electrical current through the head, thereby exciting the brain&#xD;
      underneath. TDCS is not an FDA-approved treatment for any condition, but previous trials have&#xD;
      shown it may benefit movement and language recovery after stroke, as well as improve thinking&#xD;
      ability. Studies have shown tDCS to be very safe with no serious adverse events in over&#xD;
      10,000 subjects studied.&#xD;
&#xD;
      This pilot study will involve four visits to Stony Brook University Hospital. The first is a&#xD;
      baseline session where subjects perform all outcome measures but no tDCS is performed other&#xD;
      than for familiarization. The other three sessions are the stimulation sessions where&#xD;
      subjects undergo the intervention for 20 minutes to test tDCS effects on the outcome&#xD;
      measures. The effects of tDCS for a single session are expected to only last for few hours.&#xD;
      Subjects will be receiving all three different types of stimulation. If this study finds a&#xD;
      short term benefit of tDCS for post-stroke working memory deficits, it will support a full&#xD;
      clinical trial where multiple sessions of tDCS will be given and may provide a long-term&#xD;
      benefit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Negative interim analysis.&#xD;
  </why_stopped>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Cognitive Test Battery</measure>
    <time_frame>before and after each stimulation within 2 hours.</time_frame>
    <description>A series of cognitive tests will be conducted before and after each stimulation. The tests will include a n-back test (0,1,2), a delayed recognition task, and a number capacity task.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Auditory Digit Span Test</measure>
    <time_frame>at baseline, once immediately after stimulation, one time in the evening of the session day and then one more time the day after the session</time_frame>
    <description>An auditory digit span test (forward and backward) will be asked over phone 4 times.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Stroke</condition>
  <condition>Cognitive Deficit</condition>
  <condition>Cognitive Impairment</condition>
  <condition>Short-Term Memory Impairment</condition>
  <arm_group>
    <arm_group_label>tDCS conventional stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcranial Direct Current Stimulation:&#xD;
The anode will be placed over the left dorsal lateral prefrontal cortex (DLPFC) and the cathode will be placed over the right supraorbital cortex. This is the standard 1 anode by 1 cathodal convention. Stimulation will last 20 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Definition (HD)-tDCS stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcranial Direct Current Stimulation:&#xD;
The anode will be placed over the left DLPFC and 4 cathodes will be placed surrounding the anode. This is the 4 cathode by 1 anode HD-tDCS montage for more focal stimulation. Stimulation will last 20 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>tDCS sham stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Transcranial Direct Current Stimulation:&#xD;
The anode will be placed over the left DLPFC and the cathode over the right supraorbital cortex. A short stimulation will be given to the subjects that will mimic the sensation of an actual stimulation but will last much shorter. The session will still last 20 minutes in total to blind both subjects and investigators.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial Direct Current Stimulation</intervention_name>
    <description>TDCS involves sending a weak electrical current to the brain to modulate brain functions.</description>
    <arm_group_label>High Definition (HD)-tDCS stimulation</arm_group_label>
    <arm_group_label>tDCS conventional stimulation</arm_group_label>
    <arm_group_label>tDCS sham stimulation</arm_group_label>
    <other_name>Neuroelectrics Starstim</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of stroke and radiographically proven ischemic or hemorrhagic&#xD;
             stroke (MRI required for ischemic stroke, CT sufficient for hemorrhagic stroke).&#xD;
&#xD;
          -  Subject reports a decline in attention or short-term memory that began at the time of&#xD;
             their stroke.&#xD;
&#xD;
          -  Stroke occurred at least one month prior to first stimulation session.&#xD;
&#xD;
          -  Ability to provide informed consent.&#xD;
&#xD;
          -  Speak English (required for performing the cognitive tests)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any other brain disease that can affect cognition (e.g., multiple sclerosis,&#xD;
             dementia).&#xD;
&#xD;
          -  Active mental illness such as depression or anxiety&#xD;
&#xD;
          -  Large stroke involving cortex under the stimulation site (using subject provided CT or&#xD;
             MRI).&#xD;
&#xD;
          -  Currently taking any drugs that are sodium and/or calcium channel blockers not&#xD;
             including amlodipine. This includes some seizure medications along with nicardipine,&#xD;
             nifedipine, nimodipine, verapamil and diltiazem.&#xD;
&#xD;
          -  Any history of epilepsy.&#xD;
&#xD;
          -  Subject report of recent drug or alcohol abuse - within the past year.&#xD;
&#xD;
          -  Subject report of pregnant or breastfeeding.&#xD;
&#xD;
          -  Moderate to severe aphasia preventing subject from communicating fully.&#xD;
&#xD;
          -  Any pacemakers, intracranial electrodes, implanted defibrillators, or any other&#xD;
             electrical implants.&#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>Andrew M Goldfine, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stony Brook Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stony Brook University</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007 May 30;72(4-6):208-14. doi: 10.1016/j.brainresbull.2007.01.004. Epub 2007 Jan 24.</citation>
    <PMID>17452283</PMID>
  </reference>
  <reference>
    <citation>Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, Edwards DJ, Valero-Cabre A, Rotenberg A, Pascual-Leone A, Ferrucci R, Priori A, Boggio PS, Fregni F. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul. 2012 Jul;5(3):175-195. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1.</citation>
    <PMID>22037126</PMID>
  </reference>
  <reference>
    <citation>Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.</citation>
    <PMID>27372845</PMID>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>October 19, 2017</last_update_submitted>
  <last_update_submitted_qc>October 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stony Brook University</investigator_affiliation>
    <investigator_full_name>Andrew Goldfine</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Transcranial Direct Current Stimulation</keyword>
  <keyword>Stroke</keyword>
  <keyword>Electric Stimulation Therapy</keyword>
  <keyword>Prefrontal Cortex</keyword>
  <keyword>Electroencephalography</keyword>
  <keyword>Cognition</keyword>
  <keyword>Neurological Rehabilitation</keyword>
  <keyword>Memory</keyword>
  <keyword>Working Memory</keyword>
  <keyword>Attention</keyword>
  <keyword>Concentration</keyword>
  <keyword>Short-Term Memory</keyword>
  <keyword>Planning</keyword>
  <keyword>Executive Function</keyword>
  <keyword>Cerebrovascular disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Memory Disorders</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
    <mesh_term>Cognition 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>


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/NCT03034109
org study id: 986244
nct id: NCT03034109
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to test the effects of tDCS (Transcranial Direct Current
      Stimulation) on stroke patients with working memory problems.
After having a stroke, people often have trouble remembering to do something, solving
      problems, or following conversations. They can also have trouble concentrating, following
      instructions, and multitasking. These can all due to the stroke affecting a brain function
      called "working memory". Working memory is defined as the ability to hold a thought in one's
      mind for a few seconds in order to remember a task or solve a problem. People have difficulty
      returning to their normal lives because of these working memory problems. Currently, there no
      proven medical treatments for working memory problems.

      Transcranial direct current stimulation (tDCS) is a painless, noninvasive brain stimulation
      technique that has been shown in some studies to improve working memory in healthy subjects.
      TDCS involves sending a weak electrical current through the head, thereby exciting the brain
      underneath. TDCS is not an FDA-approved treatment for any condition, but previous trials have
      shown it may benefit movement and language recovery after stroke, as well as improve thinking
      ability. Studies have shown tDCS to be very safe with no serious adverse events in over
      10,000 subjects studied.

      This pilot study will involve four visits to Stony Brook University Hospital. The first is a
      baseline session where subjects perform all outcome measures but no tDCS is performed other
      than for familiarization. The other three sessions are the stimulation sessions where
      subjects undergo the intervention for 20 minutes to test tDCS effects on the outcome
      measures. The effects of tDCS for a single session are expected to only last for few hours.
      Subjects will be receiving all three different types of stimulation. If this study finds a
      short term benefit of tDCS for post-stroke working memory deficits, it will support a full
      clinical trial where multiple sessions of tDCS will be given and may provide a long-term
      benefit.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Changes in Cognitive Test Battery
time frame: before and after each stimulation within 2 hours.
description: A series of cognitive tests will be conducted before and after each stimulation. The tests will include a n-back test (0,1,2), a delayed recognition task, and a number capacity task.
measure: Changes in Auditory Digit Span Test
time frame: at baseline, once immediately after stimulation, one time in the evening of the session day and then one more time the day after the session
description: An auditory digit span test (forward and backward) will be asked over phone 4 times.
arm group label: tDCS conventional stimulation
arm group type: Experimental
description: Transcranial Direct Current Stimulation:
The anode will be placed over the left dorsal lateral prefrontal cortex (DLPFC) and the cathode will be placed over the right supraorbital cortex. This is the standard 1 anode by 1 cathodal convention. Stimulation will last 20 minutes.
arm group label: High Definition (HD)-tDCS stimulation
arm group type: Experimental
description: Transcranial Direct Current Stimulation:
The anode will be placed over the left DLPFC and 4 cathodes will be placed surrounding the anode. This is the 4 cathode by 1 anode HD-tDCS montage for more focal stimulation. Stimulation will last 20 minutes.
arm group label: tDCS sham stimulation
arm group type: Sham Comparator
description: Transcranial Direct Current Stimulation:
The anode will be placed over the left DLPFC and the cathode over the right supraorbital cortex. A short stimulation will be given to the subjects that will mimic the sensation of an actual stimulation but will last much shorter. The session will still last 20 minutes in total to blind both subjects and investigators.
intervention type: Device
intervention name: Transcranial Direct Current Stimulation
description: TDCS involves sending a weak electrical current to the brain to modulate brain functions.
arm group label: High Definition (HD)-tDCS stimulation
arm group label: tDCS conventional stimulation
arm group label: tDCS sham stimulation
other name: Neuroelectrics Starstim
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew M Goldfine, MD
role: Principal Investigator
affiliation: Stony Brook Medicine
facility: 
country: United States
citation: Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007 May 30;72(4-6):208-14. doi: 10.1016/j.brainresbull.2007.01.004. Epub 2007 Jan 24.
PMID: 17452283
citation: Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, Edwards DJ, Valero-Cabre A, Rotenberg A, Pascual-Leone A, Ferrucci R, Priori A, Boggio PS, Fregni F. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul. 2012 Jul;5(3):175-195. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1.
PMID: 22037126
citation: Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.
PMID: 27372845
responsible party type: Principal Investigator
investigator affiliation: Stony Brook University
investigator full name: Andrew Goldfine
investigator title: Principal Investigator
mesh term: Stroke
mesh term: Memory Disorders
mesh term: Cognitive Dysfunction
mesh term: Cognition Disorders
sharing ipd: No