<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/NCT04433351</url>
  </required_header>
  <id_info>
    <org_study_id>2020-A00720-39</org_study_id>
    <nct_id>NCT04433351</nct_id>
  </id_info>
  <brief_title>Sensory-Motor Integration for Speech Rehabilitation in Patients With Post-stroke Aphasia</brief_title>
  <acronym>SEMO</acronym>
  <official_title>Evaluation of an Enriched Speech Rehabilitation Program Combining Speech Therapy and Sensory-motor Integration in Aphasic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Laboratoire de Psychologie et NeuroCognition</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>GIPSA-LAB</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Grenoble</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      SEMO is a multidisciplinary project (language sciences, cognitive psychology and&#xD;
      neuropsychology, physical medicine and rehabilitation, neurology, speech-language pathology,&#xD;
      functional neuroimaging and engineering sciences) that aims first, to test and develop a&#xD;
      novel speech rehabilitation program designed for patients with non-fluent aphasia and,&#xD;
      second, to better describe neural reorganization after successful recovery. To this end, the&#xD;
      investigators will conduct a prospective monocentric cross-over study, including two cohorts&#xD;
      of post-stroke aphasic patients and two control groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this project, the investigators propose to evaluate the effectiveness of a new&#xD;
      rehabilitation program, based on illustration of speech articulators, to improve speech in&#xD;
      patients with non-fluent aphasia. The instigators' method is based on the reinforcement of&#xD;
      the interaction between perceptual and motor representations, thanks to the innovative&#xD;
      Ultraspeech device. The investigators will exploit a fundamental psycholinguistic principle,&#xD;
      which postulates that speech is based both on the activation of the system controlling the&#xD;
      motricity of effectors related to word articulation (action) and on the auditory or visual&#xD;
      representation of words (perception). The sensory-motor interaction method that the&#xD;
      investigators propose allows the patient to perceive phonemes and visualize on a computer&#xD;
      screen the movements of the tongue and lips previously recorded by a healthy speaker,&#xD;
      typically a speech therapist. Through repeated exercises, the patient is trained to produce&#xD;
      sounds correctly, using the correct pronunciation and articulatory movements of the reference&#xD;
      speaker as a model. The investigators will compare patients who will follow a classical&#xD;
      speech and language therapy rehabilitation program followed by an 'enriched' rehabilitation&#xD;
      program including rehabilitation based on sensory-motor interaction associated with speech&#xD;
      and language therapy, and vice versa. In order to judge the favorable effect of the&#xD;
      rehabilitation program including sensory-motor integration, the following measures will be&#xD;
      considered: (a) language skills, (b) phonemic quality, (c) inner speech abilities and (d)&#xD;
      cognitive function. Brain language networks will be evaluated with neuroimaging.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 5, 2022</start_date>
  <completion_date type="Anticipated">May 2026</completion_date>
  <primary_completion_date type="Anticipated">May 2026</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Two types of rehabilitation will be compared, a simple rehabilitation (S, based on conventional speech therapy) and an enriched rehabilitation (E, based on the use of sensory-motor integration in addition to conventional speech therapy). The investigators will constitute two cohorts of patients (N=18 per cohort): a cohort SE which will carry out first the simple rehabilitation protocol followed by enriched rehabilitation, and a cohort ES which will carry out first the enriched rehabilitation protocol followed by simple rehabilitation. The protocol starts at T0 (inclusion according to defined criteria) and after a first evaluation (T1), patients will then perform the first part of the rehabilitation protocol during 4 weeks. After these 4 weeks, a second evaluation will be performed (T2). Then, the second part of the rehabilitation protocol will be carried out during 4 weeks. At the end, the T3 evaluation will be performed.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of acoustic changes in the speech signal before and after each rehabilitation protocol</measure>
    <time_frame>Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention</time_frame>
    <description>Assessment of acoustic properties (formants, voice onset time and spectral moments) with a phoneme repetition task. Repeated phonemes are isolated vowels, semi-consonants in vowel context and consonants in /a/ context with the consonants (C) placed in initial (/Ca/) or medial (/aCa/) positions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of changes in inner speech abilities before and after each rehabilitation protocol - Inner speech testing 1</measure>
    <time_frame>Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention</time_frame>
    <description>Evaluate inner speech abilities with an introspective questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of changes in inner speech abilities before and after each rehabilitation protocol - Inner speech testing 2</measure>
    <time_frame>Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention</time_frame>
    <description>Evaluate inner speech abilities with a behavioral task (homophone detection task)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical language assessment 1a</measure>
    <time_frame>Baseline pre-intervention</time_frame>
    <description>Assessment of oral and written expression with BDAE (Boston Diagnostic Aphasia Examination).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of changes in language abilities before and after rehabilitation - Clinical language assessment 1b</measure>
    <time_frame>Immediately after the first intervention; immediately after the second intervention</time_frame>
    <description>Assessment of oral expression (picture naming) with BDAE (Boston Diagnostic Aphasia Examination).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical language assessment 2a</measure>
    <time_frame>Baseline pre-intervention</time_frame>
    <description>Assessment of transcoding (word/sentence repetition and syllable/word reading) with BDAE (Boston Diagnostic Aphasia Examination).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of changes in language abilities before and after rehabilitation - Clinical language assessment 2b</measure>
    <time_frame>Immediately after the first intervention; immediately after the second intervention</time_frame>
    <description>Assessment of transcoding (word repetition and word reading) with BDAE (Boston Diagnostic Aphasia Examination).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of changes in language abilities before and after each rehabilitation protocol - Clinical language assessment 3</measure>
    <time_frame>Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention</time_frame>
    <description>Assessment of verbal fluency with phonemic and semantic fluency tasks. The patient must generate words that satisfy certain criteria: beginning with a particular letter (phonemic fluency) or belonging to a particular semantic category (semantic fluency).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical language assessment 4</measure>
    <time_frame>Baseline pre-intervention</time_frame>
    <description>Assessment of bucco-facial praxia with MT-86 (Montreal-Toulouse aphasia language examination protocol).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of changes in language abilities before and after each rehabilitation protocol - Clinical language assessment 5</measure>
    <time_frame>Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention</time_frame>
    <description>Assessment of phonemic discrimination with BALE (Batterie Analytique du Langage Ecrit).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of changes in language abilities before and after each rehabilitation protocol - Clinical language assessment 6</measure>
    <time_frame>Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention</time_frame>
    <description>Assessment of phonological awareness with a rhyme detection task. The patient must decide whether two heard words rhyme or not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of changes in cognitive level before and after each rehabilitation protocol - Neuropsychological assessment 1</measure>
    <time_frame>Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention</time_frame>
    <description>Assessment of general cognitive level with CASP (Cognitive Assessment Scale for Stroke Patients). CASP evaluates several abilities (naming, comprehension, inhibition, flexibility etc.) and the global score is out of 36.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of changes in specific executive functions before and after each rehabilitation protocol - Neuropsychological assessment 2</measure>
    <time_frame>Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention</time_frame>
    <description>Assessment of visuo-spatial span with the Corsi blocks task.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of changes in specific executive functions before and after each rehabilitation protocol - Neuropsychological assessment 3</measure>
    <time_frame>Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention</time_frame>
    <description>Assessment of non-verbal fluency with the Ruff figural fluency test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of changes in specific executive functions before and after each rehabilitation protocol - Neuropsychological assessment 4</measure>
    <time_frame>Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention</time_frame>
    <description>Assessment of executive functions with the TMT A-B (Trail Making Test A-B).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of changes in non-verbal episodic memory before and after each rehabilitation protocol - Neuropsychological assessment 5</measure>
    <time_frame>Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention</time_frame>
    <description>Assessment of non-verbal episodic memory with BEM84 (Batterie d'Efficience Mnésique de Signoret). This test contains an immediate recall task (score out of 12) and a delayed recall task (score out of 12).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of changes in mental rotation abilities before and after each rehabilitation protocol - Neuropsychological assessment 6</measure>
    <time_frame>Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention</time_frame>
    <description>Assessment of mental rotation abilities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of mood changes before and after each rehabilitation protocol - Neuropsychological assessment 7</measure>
    <time_frame>Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention</time_frame>
    <description>Assessment of depression with Aphasic Depression Rating Scale (ADRS; score out of 32; a score lower than 7 is for &quot;no depression&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of mood changes before and after each rehabilitation protocol - Neuropsychological assessment 8</measure>
    <time_frame>Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention</time_frame>
    <description>Assessment of anxiety with Hamilton scale (score out of 56; a score lower or equal to 12 is for &quot;normal anxiety&quot;; a score between 12 and 20 is for &quot;mild anxiety&quot;; a score between 20 and 25 is for &quot;moderate anxiety&quot;; a score higher than 25 is for &quot;severe anxiety&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropsychological assessment 9</measure>
    <time_frame>Baseline pre-intervention</time_frame>
    <description>Assessment of familiarity degree with digital tools with an in-house test developed by the neuropsychologists from our clinical setting. This task allows to evaluate the use of the computer tools, its frequency of use and the type of activities carried out.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of brain network activation (with measurement of BOLD, Blood Oxygen Level Dependent) before and after rehabilitation - Evaluation-brain 1</measure>
    <time_frame>Baseline pre-intervention; immediately after the first intervention</time_frame>
    <description>Assessment of brain networks modulation with fMRI (functional MRI) tasks : word repetition (repeating a heard word), picture-prompted rhyme detection (judging if verbal labels of pictures presented in pairs rhyme or not), auditory rhyme detection (decide whether two heard words rhyme of not), picture naming (naming pictures) and word reading (reading visually presented words).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of brain functional connectivity before and after rehabilitation - Evaluation-brain 2</measure>
    <time_frame>Baseline pre-intervention; immediately after the first intervention</time_frame>
    <description>Assessment of functional connectivity with rs-fMRI (resting state-functional MRI).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of brain anatomical connectivity before and after rehabilitation - Evaluation-brain 3</measure>
    <time_frame>Baseline pre-intervention; immediately after the first intervention</time_frame>
    <description>Assessment of diffuse white-matter changes in multiple bundles with MRI-DTI (Diffusion Tension Imaging).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">36</enrollment>
  <condition>Aphasia Non Fluent</condition>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>SE cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the SE cohort will carry out first the simple rehabilitation protocol (S, 4 weeks) followed by enriched rehabilitation (E, 4 weeks).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ES cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the ES cohort will carry out first the enriched rehabilitation protocol (E, 4 weeks) followed by simple rehabilitation (S, 4 weeks).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Enriched rehabilitation</intervention_name>
    <description>The enriched rehabilitation is based on the use of sensory-motor integration in addition to conventional speech therapy. The sensory-motor integration method is based on the Ultraspeech-player software. This software allows therapists to display movements of speech articulators (tongue and lips) recorded on a reference speaker during production of vowels or consonants (isolated or combined). Sagittal movements of the tongue are recorded using ultrasound and front views of lip movements are captured through video imaging.&#xD;
During rehabilitation with the Ultraspeech-player software, patients will be seated in front of a computer screen, observe articulatory movements and listen to phonemes. Then, they will be required to repeat each of them five times and move on to the next phoneme, with the agreement of the experimenter.</description>
    <arm_group_label>ES cohort</arm_group_label>
    <arm_group_label>SE cohort</arm_group_label>
    <other_name>Sensory-motor integration</other_name>
    <other_name>Illustration-based rehabilitation method</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Simple rehabilitation</intervention_name>
    <description>The simple rehabilitation is based on conventional speech therapy. The conventional speech therapy will be provided by the speech therapist. Classically, the speech therapist uses word production with repetition and naming exercises. The therapist will show the patient series of pictures associated or not with written words, and the patient is required to name them and/or read aloud the word. In case of impossibility to perform the task, the therapist may can help the patient by using the indexing method or by asking the patient to repeat after him/her. According to patient's competencies and progress, the difficulty of reeducation can increase progressively.</description>
    <arm_group_label>ES cohort</arm_group_label>
    <arm_group_label>SE cohort</arm_group_label>
    <other_name>Conventional speech therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with late sub-acute and chronic post-stroke (&gt; 4 months) non-fluent aphasia&#xD;
             after lesion in the dominant hemisphere for language&#xD;
&#xD;
          -  native speakers of French&#xD;
&#xD;
          -  normal or corrected to normal vision&#xD;
&#xD;
          -  satisfying all criteria for the MRI examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with comprehension deficits, hemi-spatial neglect or upper limb apraxia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Monica Baciu, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Grenoble &amp; Laboratoire de Psychologie et NeuroCognition</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>University Hospital, Grenoble</last_name>
    <phone>04 76 76 68 14</phone>
    <phone_ext>+33</phone_ext>
    <email>tmontagnon@chu-grenoble.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chu Grenoble Alpes</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Baciu Monica</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>May 11, 2023</last_update_submitted>
  <last_update_submitted_qc>May 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>post-stroke aphasia</keyword>
  <keyword>non-fluent aphasia</keyword>
  <keyword>speech rehabilitation</keyword>
  <keyword>neuroimaging</keyword>
  <keyword>neural reorganization</keyword>
  <keyword>recovery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Aphasia</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/NCT04433351
org study id: 2020-A00720-39
nct id: NCT04433351
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
SEMO is a multidisciplinary project (language sciences, cognitive psychology and
      neuropsychology, physical medicine and rehabilitation, neurology, speech-language pathology,
      functional neuroimaging and engineering sciences) that aims first, to test and develop a
      novel speech rehabilitation program designed for patients with non-fluent aphasia and,
      second, to better describe neural reorganization after successful recovery. To this end, the
      investigators will conduct a prospective monocentric cross-over study, including two cohorts
      of post-stroke aphasic patients and two control groups.
In this project, the investigators propose to evaluate the effectiveness of a new
      rehabilitation program, based on illustration of speech articulators, to improve speech in
      patients with non-fluent aphasia. The instigators' method is based on the reinforcement of
      the interaction between perceptual and motor representations, thanks to the innovative
      Ultraspeech device. The investigators will exploit a fundamental psycholinguistic principle,
      which postulates that speech is based both on the activation of the system controlling the
      motricity of effectors related to word articulation (action) and on the auditory or visual
      representation of words (perception). The sensory-motor interaction method that the
      investigators propose allows the patient to perceive phonemes and visualize on a computer
      screen the movements of the tongue and lips previously recorded by a healthy speaker,
      typically a speech therapist. Through repeated exercises, the patient is trained to produce
      sounds correctly, using the correct pronunciation and articulatory movements of the reference
      speaker as a model. The investigators will compare patients who will follow a classical
      speech and language therapy rehabilitation program followed by an 'enriched' rehabilitation
      program including rehabilitation based on sensory-motor interaction associated with speech
      and language therapy, and vice versa. In order to judge the favorable effect of the
      rehabilitation program including sensory-motor integration, the following measures will be
      considered: (a) language skills, (b) phonemic quality, (c) inner speech abilities and (d)
      cognitive function. Brain language networks will be evaluated with neuroimaging.
allocation: Non-Randomized
intervention model: Crossover Assignment
intervention model description: Two types of rehabilitation will be compared, a simple rehabilitation (S, based on conventional speech therapy) and an enriched rehabilitation (E, based on the use of sensory-motor integration in addition to conventional speech therapy). The investigators will constitute two cohorts of patients (N=18 per cohort): a cohort SE which will carry out first the simple rehabilitation protocol followed by enriched rehabilitation, and a cohort ES which will carry out first the enriched rehabilitation protocol followed by simple rehabilitation. The protocol starts at T0 (inclusion according to defined criteria) and after a first evaluation (T1), patients will then perform the first part of the rehabilitation protocol during 4 weeks. After these 4 weeks, a second evaluation will be performed (T2). Then, the second part of the rehabilitation protocol will be carried out during 4 weeks. At the end, the T3 evaluation will be performed.
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluation of acoustic changes in the speech signal before and after each rehabilitation protocol
time frame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
description: Assessment of acoustic properties (formants, voice onset time and spectral moments) with a phoneme repetition task. Repeated phonemes are isolated vowels, semi-consonants in vowel context and consonants in /a/ context with the consonants (C) placed in initial (/Ca/) or medial (/aCa/) positions.
measure: Evaluation of changes in inner speech abilities before and after each rehabilitation protocol - Inner speech testing 1
time frame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
description: Evaluate inner speech abilities with an introspective questionnaire
measure: Evaluation of changes in inner speech abilities before and after each rehabilitation protocol - Inner speech testing 2
time frame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
description: Evaluate inner speech abilities with a behavioral task (homophone detection task)
measure: Clinical language assessment 1a
time frame: Baseline pre-intervention
description: Assessment of oral and written expression with BDAE (Boston Diagnostic Aphasia Examination).
measure: Evaluation of changes in language abilities before and after rehabilitation - Clinical language assessment 1b
time frame: Immediately after the first intervention; immediately after the second intervention
description: Assessment of oral expression (picture naming) with BDAE (Boston Diagnostic Aphasia Examination).
measure: Clinical language assessment 2a
time frame: Baseline pre-intervention
description: Assessment of transcoding (word/sentence repetition and syllable/word reading) with BDAE (Boston Diagnostic Aphasia Examination).
measure: Evaluation of changes in language abilities before and after rehabilitation - Clinical language assessment 2b
time frame: Immediately after the first intervention; immediately after the second intervention
description: Assessment of transcoding (word repetition and word reading) with BDAE (Boston Diagnostic Aphasia Examination).
measure: Evaluation of changes in language abilities before and after each rehabilitation protocol - Clinical language assessment 3
time frame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
description: Assessment of verbal fluency with phonemic and semantic fluency tasks. The patient must generate words that satisfy certain criteria: beginning with a particular letter (phonemic fluency) or belonging to a particular semantic category (semantic fluency).
measure: Clinical language assessment 4
time frame: Baseline pre-intervention
description: Assessment of bucco-facial praxia with MT-86 (Montreal-Toulouse aphasia language examination protocol).
measure: Evaluation of changes in language abilities before and after each rehabilitation protocol - Clinical language assessment 5
time frame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
description: Assessment of phonemic discrimination with BALE (Batterie Analytique du Langage Ecrit).
measure: Evaluation of changes in language abilities before and after each rehabilitation protocol - Clinical language assessment 6
time frame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
description: Assessment of phonological awareness with a rhyme detection task. The patient must decide whether two heard words rhyme or not.
measure: Evaluation of changes in cognitive level before and after each rehabilitation protocol - Neuropsychological assessment 1
time frame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
description: Assessment of general cognitive level with CASP (Cognitive Assessment Scale for Stroke Patients). CASP evaluates several abilities (naming, comprehension, inhibition, flexibility etc.) and the global score is out of 36.
measure: Evaluation of changes in specific executive functions before and after each rehabilitation protocol - Neuropsychological assessment 2
time frame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
description: Assessment of visuo-spatial span with the Corsi blocks task.
measure: Evaluation of changes in specific executive functions before and after each rehabilitation protocol - Neuropsychological assessment 3
time frame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
description: Assessment of non-verbal fluency with the Ruff figural fluency test.
measure: Evaluation of changes in specific executive functions before and after each rehabilitation protocol - Neuropsychological assessment 4
time frame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
description: Assessment of executive functions with the TMT A-B (Trail Making Test A-B).
measure: Evaluation of changes in non-verbal episodic memory before and after each rehabilitation protocol - Neuropsychological assessment 5
time frame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
description: Assessment of non-verbal episodic memory with BEM84 (Batterie d'Efficience Mnésique de Signoret). This test contains an immediate recall task (score out of 12) and a delayed recall task (score out of 12).
measure: Evaluation of changes in mental rotation abilities before and after each rehabilitation protocol - Neuropsychological assessment 6
time frame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
description: Assessment of mental rotation abilities.
measure: Evaluation of mood changes before and after each rehabilitation protocol - Neuropsychological assessment 7
time frame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
description: Assessment of depression with Aphasic Depression Rating Scale (ADRS; score out of 32; a score lower than 7 is for "no depression").
measure: Evaluation of mood changes before and after each rehabilitation protocol - Neuropsychological assessment 8
time frame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
description: Assessment of anxiety with Hamilton scale (score out of 56; a score lower or equal to 12 is for "normal anxiety"; a score between 12 and 20 is for "mild anxiety"; a score between 20 and 25 is for "moderate anxiety"; a score higher than 25 is for "severe anxiety").
measure: Neuropsychological assessment 9
time frame: Baseline pre-intervention
description: Assessment of familiarity degree with digital tools with an in-house test developed by the neuropsychologists from our clinical setting. This task allows to evaluate the use of the computer tools, its frequency of use and the type of activities carried out.
measure: Evaluation of brain network activation (with measurement of BOLD, Blood Oxygen Level Dependent) before and after rehabilitation - Evaluation-brain 1
time frame: Baseline pre-intervention; immediately after the first intervention
description: Assessment of brain networks modulation with fMRI (functional MRI) tasks : word repetition (repeating a heard word), picture-prompted rhyme detection (judging if verbal labels of pictures presented in pairs rhyme or not), auditory rhyme detection (decide whether two heard words rhyme of not), picture naming (naming pictures) and word reading (reading visually presented words).
measure: Evaluation of brain functional connectivity before and after rehabilitation - Evaluation-brain 2
time frame: Baseline pre-intervention; immediately after the first intervention
description: Assessment of functional connectivity with rs-fMRI (resting state-functional MRI).
measure: Evaluation of brain anatomical connectivity before and after rehabilitation - Evaluation-brain 3
time frame: Baseline pre-intervention; immediately after the first intervention
description: Assessment of diffuse white-matter changes in multiple bundles with MRI-DTI (Diffusion Tension Imaging).
arm group label: SE cohort
arm group type: Experimental
description: Patients in the SE cohort will carry out first the simple rehabilitation protocol (S, 4 weeks) followed by enriched rehabilitation (E, 4 weeks).
arm group label: ES cohort
arm group type: Experimental
description: Patients in the ES cohort will carry out first the enriched rehabilitation protocol (E, 4 weeks) followed by simple rehabilitation (S, 4 weeks).
intervention type: Device
intervention name: Enriched rehabilitation
description: The enriched rehabilitation is based on the use of sensory-motor integration in addition to conventional speech therapy. The sensory-motor integration method is based on the Ultraspeech-player software. This software allows therapists to display movements of speech articulators (tongue and lips) recorded on a reference speaker during production of vowels or consonants (isolated or combined). Sagittal movements of the tongue are recorded using ultrasound and front views of lip movements are captured through video imaging.
During rehabilitation with the Ultraspeech-player software, patients will be seated in front of a computer screen, observe articulatory movements and listen to phonemes. Then, they will be required to repeat each of them five times and move on to the next phoneme, with the agreement of the experimenter.
arm group label: ES cohort
arm group label: SE cohort
other name: Sensory-motor integration
other name: Illustration-based rehabilitation method
intervention type: Device
intervention name: Simple rehabilitation
description: The simple rehabilitation is based on conventional speech therapy. The conventional speech therapy will be provided by the speech therapist. Classically, the speech therapist uses word production with repetition and naming exercises. The therapist will show the patient series of pictures associated or not with written words, and the patient is required to name them and/or read aloud the word. In case of impossibility to perform the task, the therapist may can help the patient by using the indexing method or by asking the patient to repeat after him/her. According to patient's competencies and progress, the difficulty of reeducation can increase progressively.
arm group label: ES cohort
arm group label: SE cohort
other name: Conventional speech therapy
criteria: 
gender: All
minimum age: 55 Years
maximum age: 75 Years
healthy volunteers: No
last name: Monica Baciu, MD PhD
role: Principal Investigator
affiliation: University Hospital, Grenoble & Laboratoire de Psychologie et NeuroCognition
last name: University Hospital, Grenoble
phone: 04 76 76 68 14
phone ext: +33
email: tmontagnon@chu-grenoble.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Stroke
mesh term: Aphasia
sharing ipd: No