<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/NCT03805659</url>
  </required_header>
  <id_info>
    <org_study_id>PRO00032037</org_study_id>
    <nct_id>NCT03805659</nct_id>
  </id_info>
  <brief_title>HDtDCS in Logopenic Variant PPA: Effects on Language and Neural Mechanisms</brief_title>
  <official_title>High-Definition Transcranial Direct Current Stimulation (HD-tDCS) in Logopenic Variant Primary Progressive Aphasia (lvPPA): Effects on Language and Neural Mechanisms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical College of Wisconsin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical College of Wisconsin</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to evaluate the effectiveness of a therapy called High-Definition&#xD;
      Transcranial Direct Current Stimulation (HD-tDCS) for the treatment of the language deficits&#xD;
      experienced by people with a type of Primary Progressive Aphasia. This study uses a&#xD;
      combination of brain imaging, language assessment, language training sessions, and HD-tDCS&#xD;
      therapy as well as placebo therapy sessions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The logopenic variant of Primary Progressive Aphasia (lvPPA) is an untreatable&#xD;
      neurodegenerative disorder that is often referred to as the 'language form' of Alzheimer's&#xD;
      Disease (AD). Transcranial Direct Current Stimulation (tDCS) has emerged as a safe and&#xD;
      potentially effective tool that appears to enhance language production when delivered during&#xD;
      language training. This technology provides a critical opportunity to conduct disease&#xD;
      intervention.&#xD;
&#xD;
      In this study, the investigators will test the hypothesis that High-Definition tDCS (HD-tDCS)&#xD;
      will improve performance on language tasks by increasing functional connectivity and by&#xD;
      regulating abnormal neuronal oscillatory patterns. The rationale for this project is that a&#xD;
      determination of the therapeutic efficacy and the associated neural mechanisms of HD-tDCS in&#xD;
      lvPPA is likely to offer a scientific framework whereby new stimulation parameters,&#xD;
      conditions, and target sites can be deciphered.&#xD;
&#xD;
      This study will test the hypothesis that HD-tDCS will improve performance on language tasks&#xD;
      by increasing functional connectivity and by regulating abnormal neuronal oscillatory&#xD;
      patterns. The language performance and functional connectivity changes will be determined in&#xD;
      a randomized, double-blind, sham-controlled crossover manner, in which a stimulation of up to&#xD;
      2mA in the targeted cortical tissue or sham is administered to 20 lvPPA subjects age 45 years&#xD;
      and older. The order of treatments is counterbalanced in a within-subject crossover design.&#xD;
      In brief, study participants will receive sham during one treatment period and stimulation&#xD;
      during the other treatment period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">February 24, 2020</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Actual">May 18, 2022</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>This is a randomized, double-blind, sham-controlled trial in which stimulation or sham will be administered to 20 subjects over the age of 45 years, with the order of treatments counterbalanced in a within-subject crossover design. Stimulation and sham sessions last 20 minutes and occur for 10 days over a 2-week period.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>An unblinded member of the study team will randomize participants to the treatment conditions. Study Group assignment will be based on random number generation (in blocks of 4) followed by the creation of numbered envelopes.&#xD;
Participants and the study team members involved in language training, tDCS delivery, and assessment of outcomes will be blind to the treatment received.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Language Performance on seven cognitive assessments: Picture Naming, Letter &amp; Category Fluency, Digit Span Test, Phonological Short-term Memory Test, Word and non-word rhyme matching, Spontaneous Speech Sample, and Communicative Effectiveness Index.</measure>
    <time_frame>2 weeks</time_frame>
    <description>Language performance changes as assessed at baseline and after tDCS stimulation procedures as measured by the seven assessments listed above. Scores across all tests within the language battery will be combined into one composite measure to facilitate assessment of overall language performance across domains. All seven scores will be normalized to a Z-score by transforming individual raw test scores according to the mean and standard deviation of the scores for all subjects. Then, Z-scores of each test will be averaged to obtain an individual composite language Z-score (McConathey et al., 2017). We will employ age, years of education, gender, and gray matter (GM) volume as time-invariant covariates to obtain residual variables to determine the LG changes due to stimulation. We will model the LG score as a function of these nuisance regressors. This regression will be performed using all the data (i.e., all subjects, all groups, and all times).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brain Connectivity as seen on fMRI (functional MRI)</measure>
    <time_frame>2 weeks</time_frame>
    <description>Changes in brain functional connectivity as assessed at baseline and after tDCS stimulation as measured on fMRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuronal Frequencies and Synchronizations as seen on rsMEG (resting state MEG)</measure>
    <time_frame>2 weeks</time_frame>
    <description>Changes in abnormal patterns of neuronal frequencies and synchronizations as assessed at baseline and after tDCS stimulation procedures as measured on rsMEG. Connectivity between all ROI-pairs (Region of Interest) will be calculated in the theta (4-8 Hz), alpha (8-12 Hz), beta (13-30 Hz), and low-gamma (30-55 Hz) frequency bands using three different metrics: coherence (COH), phase lag index (PLI), and debiased weighted phase lag index (d-wPLI). Mean connection strengths within 3 intra-hemispheric language-specific ROI-groups, and those between all intra-hemispheric ROIs will be computed. We will also compute mean connection strengths between language ROI-groups and all remaining brain ROIs, and those between each hemispheric ROI and all other brain ROIs.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Primary Progressive Aphasia</condition>
  <arm_group>
    <arm_group_label>HD-tDCS, then Sham</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects receive High Dose transcranial Direct Current Stimulation (HD-tDCS) lasting 20 minutes at an electric current intensity of up to 2mA in the left posterior temporo-parietal cortex (TPC). Stimulation sessions are delivered once a day (QD) for a total of 10 sessions over 2 weeks (Monday-Friday). After a washout period of 16 weeks, subjects receive Sham sessions (no electric current) once a day (QD) for a total of 10 sessions over 2 weeks (Monday-Friday).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham, then HD-tDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects receive Sham sessions (no electric current) once a day (QD) for a total of 10 sessions over 2 weeks (Monday-Friday). After a washout period of 16 weeks, subjects receive High Dose transcranial Direct Current Stimulation (HD-tDCS) lasting 20 minutes at an electric current intensity of up to 2mA in the left posterior temporo-parietal cortex (TPC). Stimulation sessions are delivered once a day (QD) for a total of 10 sessions over 2 weeks (Monday-Friday).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HD-tDCS</intervention_name>
    <description>High-Dose transcranial Direct Current Stimulation</description>
    <arm_group_label>HD-tDCS, then Sham</arm_group_label>
    <arm_group_label>Sham, then HD-tDCS</arm_group_label>
    <other_name>Soterix MXN-9 High-Definition stimulator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham</intervention_name>
    <description>Sham sessions (no electric current)</description>
    <arm_group_label>HD-tDCS, then Sham</arm_group_label>
    <arm_group_label>Sham, then HD-tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with language variant Primary Progressive Aphasia (lvPPA) subtype, defined&#xD;
             as either clinical lvPPA or imaging-supported lvPPA in accordance with the most recent&#xD;
             diagnostic criteria (Mesulam., 2001; Gorno-Tempini et al., 2011).&#xD;
&#xD;
          -  Fluent in English.&#xD;
&#xD;
          -  45 years of age or older.&#xD;
&#xD;
          -  Structural brain MRI performed within 3 years prior to enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe cognitive, auditory or visual impairments that would preclude cognitive&#xD;
             testing.&#xD;
&#xD;
          -  Presence of major untreated or unstable psychiatric disease.&#xD;
&#xD;
          -  A chronic medical condition that is not treated or is unstable.&#xD;
&#xD;
          -  The presence of cardiac stimulators or pacemakers.&#xD;
&#xD;
          -  Any metal implants in the skull&#xD;
&#xD;
          -  Contraindications to MRI&#xD;
&#xD;
          -  History of seizures&#xD;
&#xD;
          -  History of dyslexia or other developmental learning disabilities.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elias Granadillo</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Medical College of Wisconsin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Tippett DC, Hillis AE, Tsapkini K. Treatment of Primary Progressive Aphasia. Curr Treat Options Neurol. 2015 Aug;17(8):362. doi: 10.1007/s11940-015-0362-5.</citation>
    <PMID>26062526</PMID>
  </reference>
  <reference>
    <citation>Rogalski E, Cobia D, Harrison TM, Wieneke C, Weintraub S, Mesulam MM. Progression of language decline and cortical atrophy in subtypes of primary progressive aphasia. Neurology. 2011 May 24;76(21):1804-10. doi: 10.1212/WNL.0b013e31821ccd3c.</citation>
    <PMID>21606451</PMID>
  </reference>
  <reference>
    <citation>Abel S, Weiller C, Huber W, Willmes K, Specht K. Therapy-induced brain reorganization patterns in aphasia. Brain. 2015 Apr;138(Pt 4):1097-112. doi: 10.1093/brain/awv022. Epub 2015 Feb 15.</citation>
    <PMID>25688082</PMID>
  </reference>
  <reference>
    <citation>Villamar MF, Volz MS, Bikson M, Datta A, Dasilva AF, Fregni F. Technique and considerations in the use of 4x1 ring high-definition transcranial direct current stimulation (HD-tDCS). J Vis Exp. 2013 Jul 14;(77):e50309. doi: 10.3791/50309.</citation>
    <PMID>23893039</PMID>
  </reference>
  <reference>
    <citation>Meyer AM, Snider SF, Campbell RE, Friedman RB. Phonological short-term memory in logopenic variant primary progressive aphasia and mild Alzheimer's disease. Cortex. 2015 Oct;71:183-9. doi: 10.1016/j.cortex.2015.07.003. Epub 2015 Jul 16.</citation>
    <PMID>26232551</PMID>
  </reference>
  <reference>
    <citation>Pillay SB, Stengel BC, Humphries C, Book DS, Binder JR. Cerebral localization of impaired phonological retrieval during rhyme judgment. Ann Neurol. 2014 Nov;76(5):738-46. doi: 10.1002/ana.24266. Epub 2014 Sep 19.</citation>
    <PMID>25164766</PMID>
  </reference>
  <reference>
    <citation>Gorno-Tempini ML, Brambati SM, Ginex V, Ogar J, Dronkers NF, Marcone A, Perani D, Garibotto V, Cappa SF, Miller BL. The logopenic/phonological variant of primary progressive aphasia. Neurology. 2008 Oct 14;71(16):1227-34. doi: 10.1212/01.wnl.0000320506.79811.da. Epub 2008 Jul 16.</citation>
    <PMID>18633132</PMID>
  </reference>
  <reference>
    <citation>Dancause N, Barbay S, Frost SB, Plautz EJ, Chen D, Zoubina EV, Stowe AM, Nudo RJ. Extensive cortical rewiring after brain injury. J Neurosci. 2005 Nov 2;25(44):10167-79. doi: 10.1523/JNEUROSCI.3256-05.2005.</citation>
    <PMID>16267224</PMID>
  </reference>
  <reference>
    <citation>Sonty SP, Mesulam MM, Weintraub S, Johnson NA, Parrish TB, Gitelman DR. Altered effective connectivity within the language network in primary progressive aphasia. J Neurosci. 2007 Feb 7;27(6):1334-45. doi: 10.1523/JNEUROSCI.4127-06.2007.</citation>
    <PMID>17287508</PMID>
  </reference>
  <reference>
    <citation>Datta A, Bansal V, Diaz J, Patel J, Reato D, Bikson M. Gyri-precise head model of transcranial direct current stimulation: improved spatial focality using a ring electrode versus conventional rectangular pad. Brain Stimul. 2009 Oct;2(4):201-7, 207.e1. doi: 10.1016/j.brs.2009.03.005.</citation>
    <PMID>20648973</PMID>
  </reference>
  <reference>
    <citation>Datta A, Truong D, Minhas P, Parra LC, Bikson M. Inter-Individual Variation during Transcranial Direct Current Stimulation and Normalization of Dose Using MRI-Derived Computational Models. Front Psychiatry. 2012 Oct 22;3:91. doi: 10.3389/fpsyt.2012.00091. eCollection 2012.</citation>
    <PMID>23097644</PMID>
  </reference>
  <reference>
    <citation>Muthalib M, Besson P, Rothwell J, Perrey S. Focal Hemodynamic Responses in the Stimulated Hemisphere During High-Definition Transcranial Direct Current Stimulation. Neuromodulation. 2018 Jun;21(4):348-354. doi: 10.1111/ner.12632. Epub 2017 Jul 17.</citation>
    <PMID>28714545</PMID>
  </reference>
  <reference>
    <citation>Edwards D, Cortes M, Datta A, Minhas P, Wassermann EM, Bikson M. Physiological and modeling evidence for focal transcranial electrical brain stimulation in humans: a basis for high-definition tDCS. Neuroimage. 2013 Jul 1;74:266-75. doi: 10.1016/j.neuroimage.2013.01.042. Epub 2013 Jan 28.</citation>
    <PMID>23370061</PMID>
  </reference>
  <reference>
    <citation>Richardson J, Datta A, Dmochowski J, Parra LC, Fridriksson J. Feasibility of using high-definition transcranial direct current stimulation (HD-tDCS) to enhance treatment outcomes in persons with aphasia. NeuroRehabilitation. 2015;36(1):115-26. doi: 10.3233/NRE-141199.</citation>
    <PMID>25547776</PMID>
  </reference>
  <reference>
    <citation>Kuo HI, Bikson M, Datta A, Minhas P, Paulus W, Kuo MF, Nitsche MA. Comparing cortical plasticity induced by conventional and high-definition 4 x 1 ring tDCS: a neurophysiological study. Brain Stimul. 2013 Jul;6(4):644-8. doi: 10.1016/j.brs.2012.09.010. Epub 2012 Oct 13.</citation>
    <PMID>23149292</PMID>
  </reference>
  <reference>
    <citation>Hogeveen J, Grafman J, Aboseria M, David A, Bikson M, Hauner KK. Effects of High-Definition and Conventional tDCS on Response Inhibition. Brain Stimul. 2016 Sep-Oct;9(5):720-729. doi: 10.1016/j.brs.2016.04.015. Epub 2016 Apr 22.</citation>
    <PMID>27198577</PMID>
  </reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>August 26, 2022</last_update_submitted>
  <last_update_submitted_qc>August 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical College of Wisconsin</investigator_affiliation>
    <investigator_full_name>Elias Granadillo Deluque</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Adult</keyword>
  <keyword>Primary Progressive Aphasia</keyword>
  <keyword>High-definition Transcranial Direct Current Stimulation</keyword>
  <keyword>HD-tDCS</keyword>
  <keyword>Language</keyword>
  <keyword>Logopenic</keyword>
  <keyword>Magnetic Resonance Imaging</keyword>
  <keyword>MRI</keyword>
  <keyword>Magnetoencephalography</keyword>
  <keyword>MEG</keyword>
  <keyword>Brain</keyword>
  <keyword>Aphasia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aphasia</mesh_term>
    <mesh_term>Aphasia, Primary Progressive</mesh_term>
    <mesh_term>Pick Disease of the Brain</mesh_term>
    <mesh_term>Frontotemporal Dementia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 8, 2023</submitted>
    <returned>August 31, 2023</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/NCT03805659
org study id: PRO00032037
nct id: NCT03805659
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study aims to evaluate the effectiveness of a therapy called High-Definition
      Transcranial Direct Current Stimulation (HD-tDCS) for the treatment of the language deficits
      experienced by people with a type of Primary Progressive Aphasia. This study uses a
      combination of brain imaging, language assessment, language training sessions, and HD-tDCS
      therapy as well as placebo therapy sessions.
The logopenic variant of Primary Progressive Aphasia (lvPPA) is an untreatable
      neurodegenerative disorder that is often referred to as the 'language form' of Alzheimer's
      Disease (AD). Transcranial Direct Current Stimulation (tDCS) has emerged as a safe and
      potentially effective tool that appears to enhance language production when delivered during
      language training. This technology provides a critical opportunity to conduct disease
      intervention.

      In this study, the investigators will test the hypothesis that High-Definition tDCS (HD-tDCS)
      will improve performance on language tasks by increasing functional connectivity and by
      regulating abnormal neuronal oscillatory patterns. The rationale for this project is that a
      determination of the therapeutic efficacy and the associated neural mechanisms of HD-tDCS in
      lvPPA is likely to offer a scientific framework whereby new stimulation parameters,
      conditions, and target sites can be deciphered.

      This study will test the hypothesis that HD-tDCS will improve performance on language tasks
      by increasing functional connectivity and by regulating abnormal neuronal oscillatory
      patterns. The language performance and functional connectivity changes will be determined in
      a randomized, double-blind, sham-controlled crossover manner, in which a stimulation of up to
      2mA in the targeted cortical tissue or sham is administered to 20 lvPPA subjects age 45 years
      and older. The order of treatments is counterbalanced in a within-subject crossover design.
      In brief, study participants will receive sham during one treatment period and stimulation
      during the other treatment period.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This is a randomized, double-blind, sham-controlled trial in which stimulation or sham will be administered to 20 subjects over the age of 45 years, with the order of treatments counterbalanced in a within-subject crossover design. Stimulation and sham sessions last 20 minutes and occur for 10 days over a 2-week period.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: An unblinded member of the study team will randomize participants to the treatment conditions. Study Group assignment will be based on random number generation (in blocks of 4) followed by the creation of numbered envelopes.
Participants and the study team members involved in language training, tDCS delivery, and assessment of outcomes will be blind to the treatment received.
measure: Language Performance on seven cognitive assessments: Picture Naming, Letter & Category Fluency, Digit Span Test, Phonological Short-term Memory Test, Word and non-word rhyme matching, Spontaneous Speech Sample, and Communicative Effectiveness Index.
time frame: 2 weeks
description: Language performance changes as assessed at baseline and after tDCS stimulation procedures as measured by the seven assessments listed above. Scores across all tests within the language battery will be combined into one composite measure to facilitate assessment of overall language performance across domains. All seven scores will be normalized to a Z-score by transforming individual raw test scores according to the mean and standard deviation of the scores for all subjects. Then, Z-scores of each test will be averaged to obtain an individual composite language Z-score (McConathey et al., 2017). We will employ age, years of education, gender, and gray matter (GM) volume as time-invariant covariates to obtain residual variables to determine the LG changes due to stimulation. We will model the LG score as a function of these nuisance regressors. This regression will be performed using all the data (i.e., all subjects, all groups, and all times).
measure: Brain Connectivity as seen on fMRI (functional MRI)
time frame: 2 weeks
description: Changes in brain functional connectivity as assessed at baseline and after tDCS stimulation as measured on fMRI
measure: Neuronal Frequencies and Synchronizations as seen on rsMEG (resting state MEG)
time frame: 2 weeks
description: Changes in abnormal patterns of neuronal frequencies and synchronizations as assessed at baseline and after tDCS stimulation procedures as measured on rsMEG. Connectivity between all ROI-pairs (Region of Interest) will be calculated in the theta (4-8 Hz), alpha (8-12 Hz), beta (13-30 Hz), and low-gamma (30-55 Hz) frequency bands using three different metrics: coherence (COH), phase lag index (PLI), and debiased weighted phase lag index (d-wPLI). Mean connection strengths within 3 intra-hemispheric language-specific ROI-groups, and those between all intra-hemispheric ROIs will be computed. We will also compute mean connection strengths between language ROI-groups and all remaining brain ROIs, and those between each hemispheric ROI and all other brain ROIs.
arm group label: HD-tDCS, then Sham
arm group type: Experimental
description: Subjects receive High Dose transcranial Direct Current Stimulation (HD-tDCS) lasting 20 minutes at an electric current intensity of up to 2mA in the left posterior temporo-parietal cortex (TPC). Stimulation sessions are delivered once a day (QD) for a total of 10 sessions over 2 weeks (Monday-Friday). After a washout period of 16 weeks, subjects receive Sham sessions (no electric current) once a day (QD) for a total of 10 sessions over 2 weeks (Monday-Friday).
arm group label: Sham, then HD-tDCS
arm group type: Experimental
description: Subjects receive Sham sessions (no electric current) once a day (QD) for a total of 10 sessions over 2 weeks (Monday-Friday). After a washout period of 16 weeks, subjects receive High Dose transcranial Direct Current Stimulation (HD-tDCS) lasting 20 minutes at an electric current intensity of up to 2mA in the left posterior temporo-parietal cortex (TPC). Stimulation sessions are delivered once a day (QD) for a total of 10 sessions over 2 weeks (Monday-Friday).
intervention type: Device
intervention name: HD-tDCS
description: High-Dose transcranial Direct Current Stimulation
arm group label: HD-tDCS, then Sham
arm group label: Sham, then HD-tDCS
other name: Soterix MXN-9 High-Definition stimulator
intervention type: Device
intervention name: Sham
description: Sham sessions (no electric current)
arm group label: HD-tDCS, then Sham
arm group label: Sham, then HD-tDCS
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
last name: Elias Granadillo
role: Principal Investigator
affiliation: The Medical College of Wisconsin
facility: 
country: United States
citation: Tippett DC, Hillis AE, Tsapkini K. Treatment of Primary Progressive Aphasia. Curr Treat Options Neurol. 2015 Aug;17(8):362. doi: 10.1007/s11940-015-0362-5.
PMID: 26062526
citation: Rogalski E, Cobia D, Harrison TM, Wieneke C, Weintraub S, Mesulam MM. Progression of language decline and cortical atrophy in subtypes of primary progressive aphasia. Neurology. 2011 May 24;76(21):1804-10. doi: 10.1212/WNL.0b013e31821ccd3c.
PMID: 21606451
citation: Abel S, Weiller C, Huber W, Willmes K, Specht K. Therapy-induced brain reorganization patterns in aphasia. Brain. 2015 Apr;138(Pt 4):1097-112. doi: 10.1093/brain/awv022. Epub 2015 Feb 15.
PMID: 25688082
citation: Villamar MF, Volz MS, Bikson M, Datta A, Dasilva AF, Fregni F. Technique and considerations in the use of 4x1 ring high-definition transcranial direct current stimulation (HD-tDCS). J Vis Exp. 2013 Jul 14;(77):e50309. doi: 10.3791/50309.
PMID: 23893039
citation: Meyer AM, Snider SF, Campbell RE, Friedman RB. Phonological short-term memory in logopenic variant primary progressive aphasia and mild Alzheimer's disease. Cortex. 2015 Oct;71:183-9. doi: 10.1016/j.cortex.2015.07.003. Epub 2015 Jul 16.
PMID: 26232551
citation: Pillay SB, Stengel BC, Humphries C, Book DS, Binder JR. Cerebral localization of impaired phonological retrieval during rhyme judgment. Ann Neurol. 2014 Nov;76(5):738-46. doi: 10.1002/ana.24266. Epub 2014 Sep 19.
PMID: 25164766
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responsible party type: Principal Investigator
investigator affiliation: Medical College of Wisconsin
investigator full name: Elias Granadillo Deluque
investigator title: Assistant Professor
mesh term: Aphasia
mesh term: Aphasia, Primary Progressive
mesh term: Pick Disease of the Brain
mesh term: Frontotemporal Dementia
sharing ipd: No
submitted: August 8, 2023
returned: August 31, 2023