<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/NCT02999282</url>
  </required_header>
  <id_info>
    <org_study_id>NP2441</org_study_id>
    <nct_id>NCT02999282</nct_id>
  </id_info>
  <brief_title>Rehabilitative Trial for the Rescue of Neurophysiological Parameters in Progranulin Deficient Subjects</brief_title>
  <acronym>ReRescuePGR</acronym>
  <official_title>Rehabilitative Trial for the Recovery of Neurophysiological Parameters in Progranulin Mutation Carriers Through the Use of Transcranial Direct Current Stimulation (tDCS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this randomized, double-blind, sham-controlled study, the investigators will evaluate the&#xD;
      effects of frontal and prefrontal anodal transcranial direct current stimulation (tDCS) on&#xD;
      neurophysiological parameters of cortical connectivity, assessed by transcranial magnetic&#xD;
      stimulation (TMS), in asymptomatic subjects bearing a pathogenic GRN mutation and in&#xD;
      symptomatic patients with frontotemporal dementia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this randomized, double-blind, sham-controlled study, the investigators will evaluate the&#xD;
      effects of frontal and prefrontal anodal transcranial magnetic stimulation (tDCS) on&#xD;
      neurophysiological parameters of cortical connectivity, assessed by transcranial magnetic&#xD;
      stimulation (TMS), in asymptomatic subjects bearing a pathogenic GRN mutation and in&#xD;
      symptomatic patients with frontotemporal dementia.&#xD;
&#xD;
      All patients will undergo genetic screening for progranulin mutations, a baseline&#xD;
      neuropsychological and neurophysiological evaluation, including assessment of short interval&#xD;
      intracortical inhibition, intracortical facilitation, short interval intracortical&#xD;
      facilitation and long interval intracortical inhibition. Subjects will then be randomized in&#xD;
      two groups, one receiving a 10 day (5 days/week for 2 weeks) treatment with anodal frontal&#xD;
      and prefrontal anodal tDCS and the other receiving sham stimulation with identical&#xD;
      parameters. After the intervention, patients will be reassessed with a neuropsychological and&#xD;
      neurophysiological evaluation at 2 weeks, 1 month (only neurophysiological evaluation), 3&#xD;
      months and 6 month after treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 31, 2016</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in SICI measurements from Baseline</measure>
    <time_frame>Baseline - 2 weeks</time_frame>
    <description>By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation on short interval intracortical inhibition (SICI)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in ICF measurements from Baseline</measure>
    <time_frame>Baseline - 2 weeks</time_frame>
    <description>By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation on intracortical facilitation (ICF).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in SICI measurements from Baseline</measure>
    <time_frame>Baseline - 1 month - 3 months - 6 months</time_frame>
    <description>By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation on short interval intracortical inhibition (SICI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in ICF measurements from Baseline</measure>
    <time_frame>Baseline - 1 month - 3 months - 6 months</time_frame>
    <description>By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation on intracortical facilitation (ICF).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in LICI measurements from Baseline</measure>
    <time_frame>Baseline - 1 month - 3 months - 6 months</time_frame>
    <description>By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation on long interval intracortical inhibition (LICI).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SICF measurements from Baseline</measure>
    <time_frame>Baseline - 1 month - 3 months - 6 months</time_frame>
    <description>By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation on short interval intracortical facilitation (SICF).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in MMSE scores from Baseline</measure>
    <time_frame>Baseline - 2 weeks - 3 months - 6 months</time_frame>
    <description>The Mini Mental State Examination (MMMSE) is a 30-point questionnaire that is used to measure cognitive impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in phonemic fluencies scores from Baseline</measure>
    <time_frame>Baseline - 2 weeks - 3 months - 6 months</time_frame>
    <description>Produce as many words as possible beginning with a specified letter in 60 seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in semantic fluencies scores from Baseline</measure>
    <time_frame>Baseline - 2 weeks - 3 months - 6 months</time_frame>
    <description>Produce as many words as possible from a category in 60 seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in digit span forward scores from Baseline</measure>
    <time_frame>Baseline - 2 weeks - 3 months - 6 months</time_frame>
    <description>Participants hear a sequence of numerical digits and are tasked to recall the sequence correctly, with increasingly longer sequences being tested in each trial. The participant's span is the longest number of sequential digits that can accurately be remembered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in digit span backward scores from Baseline</measure>
    <time_frame>Baseline - 2 weeks - 3 months - 6 months</time_frame>
    <description>Participants hear a sequence of numerical digits and are tasked to recall the sequence correctly in reverse order, with increasingly longer sequences being tested in each trial. The participant's span is the longest number of sequential digits that can accurately be remembered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in camel and cactus test scores from Baseline</measure>
    <time_frame>Baseline - 2 weeks - 3 months - 6 months</time_frame>
    <description>Evaluates associative semantic memory with 64 items presented for naming and word-picture matching.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in TMTA scores from Baseline</measure>
    <time_frame>Baseline - 2 weeks - 3 months - 6 months</time_frame>
    <description>The task requires a subject to connect a sequence of 25 consecutive targets on a sheet of paper to examine cognitive processing speed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in TMTB scores from Baseline</measure>
    <time_frame>Baseline - 2 weeks - 3 months - 6 months</time_frame>
    <description>The task requires a subject to connect a sequence of 25 consecutive targets on a sheet of paper, alternating between numbers and letters, to examine executive functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Stroop test scores from Baseline</measure>
    <time_frame>Baseline - 2 weeks - 3 months - 6 months</time_frame>
    <description>Measure a person's selective attention capacity and skills, as well as their processing speed ability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Symbol Digit test scores from Baseline</measure>
    <time_frame>Baseline - 2 weeks - 3 months - 6 months</time_frame>
    <description>It consists of digit-symbol pairs followed by a list of digits. Under each digit the subject should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time is measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Block Design test scores from Baseline</measure>
    <time_frame>Baseline - 2 weeks - 3 months - 6 months</time_frame>
    <description>To evaluated spatial visualization ability and motor skills. The test-taker uses hand movements to rearrange blocks that have various color patterns on different sides to match a pattern. The items in a block design test are scored both by accuracy in matching the pattern and by speed in completing each item.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in The modified EkmanFaces Test from Baseline</measure>
    <time_frame>Baseline - 2 weeks - 3 months - 6 months</time_frame>
    <description>Each face is presented on a sheet with six labels of basic emotions below the photograph. The patient was required to respond verbally, deciding the label that best described the facial expression shown.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Frontotemporal Dementia</condition>
  <condition>GRN Related Frontotemporal Dementia</condition>
  <arm_group>
    <arm_group_label>Presymptomatic real tDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Asymptomatic subjects - 10 days anodal transcranial direct current stimulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Presymptomatic sham tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Asymptomatic subjects - 10 days sham transcranial direct current stimulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Symptomatic real tDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Symptomatic patients - 10 days anodal transcranial direct current stimulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Symptomatic sham tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Symptomatic patients - 10 days sham transcranial direct current stimulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Anodal transcranial direct current stimulation</intervention_name>
    <description>10 sessions of anodal transcranial direct current stimulation (5 days/week for 2 weeks)</description>
    <arm_group_label>Presymptomatic real tDCS</arm_group_label>
    <arm_group_label>Symptomatic real tDCS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham transcranial direct current stimulation</intervention_name>
    <description>10 sessions of sham transcranial direct current stimulation (5 days/week for 2 weeks)</description>
    <arm_group_label>Presymptomatic sham tDCS</arm_group_label>
    <arm_group_label>Symptomatic sham tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: presymptomatic carriers, symptomatic genetic FTD patients, symptomatic&#xD;
        sporadic FTD patients.&#xD;
&#xD;
          -  Presymptomatic carriers: defined as participants who are known carriers of a&#xD;
             pathogenic mutation in the GRN gene, who do not fulfill current criteria for the&#xD;
             behavioral variant FTD (bvFTD) (Rascovsky et al. 2011) or for the Primary Progressive&#xD;
             Aphasias (PPA) (Gorno-Tempini et al. 2011). All subjects will be genotyped for known&#xD;
             pathogenic mutations for FTD (GRN, C9orf72, MAPT, TDP-43) before participation.&#xD;
&#xD;
          -  Symptomatic genetic FTD: defined as patients who are known carriers of pathogenic&#xD;
             mutation in the GRN gene, fulfilling current clinical criteria for behavioral variant&#xD;
             FTD (bvFTD) (Rascovsky et al. 2011) or the agrammatic variant of Primary Progressive&#xD;
             Aphasia (avPPA) (Gorno-Tempini et al. 2011).&#xD;
&#xD;
          -  Symptomatic sporadic FTD: defined as patients fulfilling current clinical criteria for&#xD;
             behavioral variant FTD (bvFTD) (Rascovsky et al. 2011) or the agrammatic variant of&#xD;
             Primary Progressive Aphasia (avPPA) (Gorno-Tempini et al. 2011), with a negative&#xD;
             screening for pathogenic mutations in known FTD genes (GRN, C9orf72, MAPT, TDP-43).&#xD;
             CSF analysis or amyloid PET imaging will be carried out to exclude focal variants of&#xD;
             AD.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cerebrovascular disorders, previous stroke, hydrocephalus, and intra-cranial mass&#xD;
             documented by MRI.&#xD;
&#xD;
          -  History of traumatic brain injury or other neurological diseases.&#xD;
&#xD;
          -  Serious medical illness other than FTD&#xD;
&#xD;
          -  History of seizures&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Metal implants in the head (except dental fillings)&#xD;
&#xD;
          -  Electronic implants (i.e. pace-maker, implanted medical pump)&#xD;
&#xD;
          -  Age &lt;18 years&#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>Barbara Borroni, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliera Spedali Civili, Brescia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alberto Benussi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Università degli Studi di Brescia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Azienda Ospedaliera Spedali Civili di Brescia</name>
      <address>
        <city>Brescia</city>
        <zip>25123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Benussi A, Cosseddu M, Filareto I, Dell'Era V, Archetti S, Sofia Cotelli M, Micheli A, Padovani A, Borroni B. Impaired long-term potentiation-like cortical plasticity in presymptomatic genetic frontotemporal dementia. Ann Neurol. 2016 Sep;80(3):472-6. doi: 10.1002/ana.24731. Epub 2016 Aug 10.</citation>
    <PMID>27438089</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>
  <reference>
    <citation>Rossini PM, Burke D, Chen R, Cohen LG, Daskalakis Z, Di Iorio R, Di Lazzaro V, Ferreri F, Fitzgerald PB, George MS, Hallett M, Lefaucheur JP, Langguth B, Matsumoto H, Miniussi C, Nitsche MA, Pascual-Leone A, Paulus W, Rossi S, Rothwell JC, Siebner HR, Ugawa Y, Walsh V, Ziemann U. Non-invasive electrical and magnetic stimulation of the brain, spinal cord, roots and peripheral nerves: Basic principles and procedures for routine clinical and research application. An updated report from an I.F.C.N. Committee. Clin Neurophysiol. 2015 Jun;126(6):1071-1107. doi: 10.1016/j.clinph.2015.02.001. Epub 2015 Feb 10.</citation>
    <PMID>25797650</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>March 1, 2020</last_update_submitted>
  <last_update_submitted_qc>March 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia</investigator_affiliation>
    <investigator_full_name>Barbara Borroni</investigator_full_name>
    <investigator_title>Associated Professor; MD</investigator_title>
  </responsible_party>
  <keyword>TMS</keyword>
  <keyword>tDCS</keyword>
  <keyword>Rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Frontotemporal Dementia</mesh_term>
    <mesh_term>Aphasia, Primary Progressive</mesh_term>
    <mesh_term>Pick Disease of the Brain</mesh_term>
    <mesh_term>Frontotemporal Lobar Degeneration</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All data, including outcome measure results, study protocol and statistical analysis plan, will be shared.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Data will be shared after the study completion indefinitely.</ipd_time_frame>
    <ipd_access_criteria>Reasonable request</ipd_access_criteria>
  </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/NCT02999282
org study id: NP2441
nct id: NCT02999282
lead sponsor: 
has dmc: Yes
In this randomized, double-blind, sham-controlled study, the investigators will evaluate the
      effects of frontal and prefrontal anodal transcranial direct current stimulation (tDCS) on
      neurophysiological parameters of cortical connectivity, assessed by transcranial magnetic
      stimulation (TMS), in asymptomatic subjects bearing a pathogenic GRN mutation and in
      symptomatic patients with frontotemporal dementia.
In this randomized, double-blind, sham-controlled study, the investigators will evaluate the
      effects of frontal and prefrontal anodal transcranial magnetic stimulation (tDCS) on
      neurophysiological parameters of cortical connectivity, assessed by transcranial magnetic
      stimulation (TMS), in asymptomatic subjects bearing a pathogenic GRN mutation and in
      symptomatic patients with frontotemporal dementia.

      All patients will undergo genetic screening for progranulin mutations, a baseline
      neuropsychological and neurophysiological evaluation, including assessment of short interval
      intracortical inhibition, intracortical facilitation, short interval intracortical
      facilitation and long interval intracortical inhibition. Subjects will then be randomized in
      two groups, one receiving a 10 day (5 days/week for 2 weeks) treatment with anodal frontal
      and prefrontal anodal tDCS and the other receiving sham stimulation with identical
      parameters. After the intervention, patients will be reassessed with a neuropsychological and
      neurophysiological evaluation at 2 weeks, 1 month (only neurophysiological evaluation), 3
      months and 6 month after treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change in SICI measurements from Baseline
time frame: Baseline - 2 weeks
description: By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation on short interval intracortical inhibition (SICI)
measure: Change in ICF measurements from Baseline
time frame: Baseline - 2 weeks
description: By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation on intracortical facilitation (ICF).
measure: Change in SICI measurements from Baseline
time frame: Baseline - 1 month - 3 months - 6 months
description: By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation on short interval intracortical inhibition (SICI)
measure: Change in ICF measurements from Baseline
time frame: Baseline - 1 month - 3 months - 6 months
description: By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation on intracortical facilitation (ICF).
measure: Change in LICI measurements from Baseline
time frame: Baseline - 1 month - 3 months - 6 months
description: By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation on long interval intracortical inhibition (LICI).
measure: Change in SICF measurements from Baseline
time frame: Baseline - 1 month - 3 months - 6 months
description: By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation on short interval intracortical facilitation (SICF).
measure: Change in MMSE scores from Baseline
time frame: Baseline - 2 weeks - 3 months - 6 months
description: The Mini Mental State Examination (MMMSE) is a 30-point questionnaire that is used to measure cognitive impairment.
measure: Change in phonemic fluencies scores from Baseline
time frame: Baseline - 2 weeks - 3 months - 6 months
description: Produce as many words as possible beginning with a specified letter in 60 seconds
measure: Change in semantic fluencies scores from Baseline
time frame: Baseline - 2 weeks - 3 months - 6 months
description: Produce as many words as possible from a category in 60 seconds
measure: Change in digit span forward scores from Baseline
time frame: Baseline - 2 weeks - 3 months - 6 months
description: Participants hear a sequence of numerical digits and are tasked to recall the sequence correctly, with increasingly longer sequences being tested in each trial. The participant's span is the longest number of sequential digits that can accurately be remembered.
measure: Change in digit span backward scores from Baseline
time frame: Baseline - 2 weeks - 3 months - 6 months
description: Participants hear a sequence of numerical digits and are tasked to recall the sequence correctly in reverse order, with increasingly longer sequences being tested in each trial. The participant's span is the longest number of sequential digits that can accurately be remembered.
measure: Change in camel and cactus test scores from Baseline
time frame: Baseline - 2 weeks - 3 months - 6 months
description: Evaluates associative semantic memory with 64 items presented for naming and word-picture matching.
measure: Change in TMTA scores from Baseline
time frame: Baseline - 2 weeks - 3 months - 6 months
description: The task requires a subject to connect a sequence of 25 consecutive targets on a sheet of paper to examine cognitive processing speed.
measure: Change in TMTB scores from Baseline
time frame: Baseline - 2 weeks - 3 months - 6 months
description: The task requires a subject to connect a sequence of 25 consecutive targets on a sheet of paper, alternating between numbers and letters, to examine executive functioning.
measure: Change in Stroop test scores from Baseline
time frame: Baseline - 2 weeks - 3 months - 6 months
description: Measure a person's selective attention capacity and skills, as well as their processing speed ability.
measure: Change in Symbol Digit test scores from Baseline
time frame: Baseline - 2 weeks - 3 months - 6 months
description: It consists of digit-symbol pairs followed by a list of digits. Under each digit the subject should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time is measured.
measure: Change in Block Design test scores from Baseline
time frame: Baseline - 2 weeks - 3 months - 6 months
description: To evaluated spatial visualization ability and motor skills. The test-taker uses hand movements to rearrange blocks that have various color patterns on different sides to match a pattern. The items in a block design test are scored both by accuracy in matching the pattern and by speed in completing each item.
measure: Change in The modified EkmanFaces Test from Baseline
time frame: Baseline - 2 weeks - 3 months - 6 months
description: Each face is presented on a sheet with six labels of basic emotions below the photograph. The patient was required to respond verbally, deciding the label that best described the facial expression shown.
arm group label: Presymptomatic real tDCS
arm group type: Experimental
description: Asymptomatic subjects - 10 days anodal transcranial direct current stimulation
arm group label: Presymptomatic sham tDCS
arm group type: Sham Comparator
description: Asymptomatic subjects - 10 days sham transcranial direct current stimulation
arm group label: Symptomatic real tDCS
arm group type: Experimental
description: Symptomatic patients - 10 days anodal transcranial direct current stimulation
arm group label: Symptomatic sham tDCS
arm group type: Sham Comparator
description: Symptomatic patients - 10 days sham transcranial direct current stimulation
intervention type: Device
intervention name: Anodal transcranial direct current stimulation
description: 10 sessions of anodal transcranial direct current stimulation (5 days/week for 2 weeks)
arm group label: Presymptomatic real tDCS
arm group label: Symptomatic real tDCS
intervention type: Device
intervention name: Sham transcranial direct current stimulation
description: 10 sessions of sham transcranial direct current stimulation (5 days/week for 2 weeks)
arm group label: Presymptomatic sham tDCS
arm group label: Symptomatic sham tDCS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Barbara Borroni, MD
role: Principal Investigator
affiliation: Azienda Ospedaliera Spedali Civili, Brescia
last name: Alberto Benussi, MD
role: Principal Investigator
affiliation: Università degli Studi di Brescia
facility: 
country: Italy
citation: Benussi A, Cosseddu M, Filareto I, Dell'Era V, Archetti S, Sofia Cotelli M, Micheli A, Padovani A, Borroni B. Impaired long-term potentiation-like cortical plasticity in presymptomatic genetic frontotemporal dementia. Ann Neurol. 2016 Sep;80(3):472-6. doi: 10.1002/ana.24731. Epub 2016 Aug 10.
PMID: 27438089
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
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PMID: 25797650
responsible party type: Principal Investigator
investigator affiliation: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
investigator full name: Barbara Borroni
investigator title: Associated Professor; MD
mesh term: Dementia
mesh term: Frontotemporal Dementia
mesh term: Aphasia, Primary Progressive
mesh term: Pick Disease of the Brain
mesh term: Frontotemporal Lobar Degeneration
sharing ipd: Yes
ipd description: All data, including outcome measure results, study protocol and statistical analysis plan, will be shared.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Data will be shared after the study completion indefinitely.
ipd access criteria: Reasonable request