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Sensory-Motor Integration for Speech Rehabilitation in Patients With Post-stroke Aphasia (SEMO)

Primary Purpose

Aphasia Non Fluent, Stroke

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Enriched rehabilitation
Simple rehabilitation
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia Non Fluent focused on measuring post-stroke aphasia, non-fluent aphasia, speech rehabilitation, neuroimaging, neural reorganization, recovery

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with late sub-acute and chronic post-stroke (> 4 months) non-fluent aphasia after lesion in the dominant hemisphere for language
  • native speakers of French
  • normal or corrected to normal vision
  • satisfying all criteria for the MRI examination

Exclusion Criteria:

  • patients with comprehension deficits, hemi-spatial neglect or upper limb apraxia

Sites / Locations

  • Chu Grenoble AlpesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SE cohort

ES cohort

Arm Description

Patients in the SE cohort will carry out first the simple rehabilitation protocol (S, 4 weeks) followed by enriched rehabilitation (E, 4 weeks).

Patients in the ES cohort will carry out first the enriched rehabilitation protocol (E, 4 weeks) followed by simple rehabilitation (S, 4 weeks).

Outcomes

Primary Outcome Measures

Evaluation of acoustic changes in the speech signal before and after each rehabilitation protocol
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.

Secondary Outcome Measures

Evaluation of changes in inner speech abilities before and after each rehabilitation protocol - Inner speech testing 1
Evaluate inner speech abilities with an introspective questionnaire
Evaluation of changes in inner speech abilities before and after each rehabilitation protocol - Inner speech testing 2
Evaluate inner speech abilities with a behavioral task (homophone detection task)
Clinical language assessment 1a
Assessment of oral and written expression with BDAE (Boston Diagnostic Aphasia Examination).
Evaluation of changes in language abilities before and after rehabilitation - Clinical language assessment 1b
Assessment of oral expression (picture naming) with BDAE (Boston Diagnostic Aphasia Examination).
Clinical language assessment 2a
Assessment of transcoding (word/sentence repetition and syllable/word reading) with BDAE (Boston Diagnostic Aphasia Examination).
Evaluation of changes in language abilities before and after rehabilitation - Clinical language assessment 2b
Assessment of transcoding (word repetition and word reading) with BDAE (Boston Diagnostic Aphasia Examination).
Evaluation of changes in language abilities before and after each rehabilitation protocol - Clinical language assessment 3
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).
Clinical language assessment 4
Assessment of bucco-facial praxia with MT-86 (Montreal-Toulouse aphasia language examination protocol).
Evaluation of changes in language abilities before and after each rehabilitation protocol - Clinical language assessment 5
Assessment of phonemic discrimination with BALE (Batterie Analytique du Langage Ecrit).
Evaluation of changes in language abilities before and after each rehabilitation protocol - Clinical language assessment 6
Assessment of phonological awareness with a rhyme detection task. The patient must decide whether two heard words rhyme or not.
Evaluation of changes in cognitive level before and after each rehabilitation protocol - Neuropsychological assessment 1
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.
Evaluation of changes in specific executive functions before and after each rehabilitation protocol - Neuropsychological assessment 2
Assessment of visuo-spatial span with the Corsi blocks task.
Evaluation of changes in specific executive functions before and after each rehabilitation protocol - Neuropsychological assessment 3
Assessment of non-verbal fluency with the Ruff figural fluency test.
Evaluation of changes in specific executive functions before and after each rehabilitation protocol - Neuropsychological assessment 4
Assessment of executive functions with the TMT A-B (Trail Making Test A-B).
Evaluation of changes in non-verbal episodic memory before and after each rehabilitation protocol - Neuropsychological assessment 5
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).
Evaluation of changes in mental rotation abilities before and after each rehabilitation protocol - Neuropsychological assessment 6
Assessment of mental rotation abilities.
Evaluation of mood changes before and after each rehabilitation protocol - Neuropsychological assessment 7
Assessment of depression with Aphasic Depression Rating Scale (ADRS; score out of 32; a score lower than 7 is for "no depression").
Evaluation of mood changes before and after each rehabilitation protocol - Neuropsychological assessment 8
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").
Neuropsychological assessment 9
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.
Evaluation of brain network activation (with measurement of BOLD, Blood Oxygen Level Dependent) before and after rehabilitation - Evaluation-brain 1
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).
Evaluation of brain functional connectivity before and after rehabilitation - Evaluation-brain 2
Assessment of functional connectivity with rs-fMRI (resting state-functional MRI).
Evaluation of brain anatomical connectivity before and after rehabilitation - Evaluation-brain 3
Assessment of diffuse white-matter changes in multiple bundles with MRI-DTI (Diffusion Tension Imaging).

Full Information

First Posted
May 19, 2020
Last Updated
May 11, 2023
Sponsor
University Hospital, Grenoble
Collaborators
Laboratoire de Psychologie et NeuroCognition, GIPSA-LAB
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1. Study Identification

Unique Protocol Identification Number
NCT04433351
Brief Title
Sensory-Motor Integration for Speech Rehabilitation in Patients With Post-stroke Aphasia
Acronym
SEMO
Official Title
Evaluation of an Enriched Speech Rehabilitation Program Combining Speech Therapy and Sensory-motor Integration in Aphasic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2022 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
Laboratoire de Psychologie et NeuroCognition, GIPSA-LAB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia Non Fluent, Stroke
Keywords
post-stroke aphasia, non-fluent aphasia, speech rehabilitation, neuroimaging, neural reorganization, recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SE cohort
Arm Type
Experimental
Arm 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 Title
ES cohort
Arm Type
Experimental
Arm 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(s)
Enriched rehabilitation
Other Intervention Name(s)
Sensory-motor integration, Illustration-based rehabilitation method
Intervention 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.
Intervention Type
Device
Intervention Name(s)
Simple rehabilitation
Other Intervention Name(s)
Conventional speech therapy
Intervention 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.
Primary Outcome Measure Information:
Title
Evaluation of acoustic changes in the speech signal before and after each rehabilitation protocol
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.
Time Frame
Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Secondary Outcome Measure Information:
Title
Evaluation of changes in inner speech abilities before and after each rehabilitation protocol - Inner speech testing 1
Description
Evaluate inner speech abilities with an introspective questionnaire
Time Frame
Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Title
Evaluation of changes in inner speech abilities before and after each rehabilitation protocol - Inner speech testing 2
Description
Evaluate inner speech abilities with a behavioral task (homophone detection task)
Time Frame
Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Title
Clinical language assessment 1a
Description
Assessment of oral and written expression with BDAE (Boston Diagnostic Aphasia Examination).
Time Frame
Baseline pre-intervention
Title
Evaluation of changes in language abilities before and after rehabilitation - Clinical language assessment 1b
Description
Assessment of oral expression (picture naming) with BDAE (Boston Diagnostic Aphasia Examination).
Time Frame
Immediately after the first intervention; immediately after the second intervention
Title
Clinical language assessment 2a
Description
Assessment of transcoding (word/sentence repetition and syllable/word reading) with BDAE (Boston Diagnostic Aphasia Examination).
Time Frame
Baseline pre-intervention
Title
Evaluation of changes in language abilities before and after rehabilitation - Clinical language assessment 2b
Description
Assessment of transcoding (word repetition and word reading) with BDAE (Boston Diagnostic Aphasia Examination).
Time Frame
Immediately after the first intervention; immediately after the second intervention
Title
Evaluation of changes in language abilities before and after each rehabilitation protocol - Clinical language assessment 3
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).
Time Frame
Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Title
Clinical language assessment 4
Description
Assessment of bucco-facial praxia with MT-86 (Montreal-Toulouse aphasia language examination protocol).
Time Frame
Baseline pre-intervention
Title
Evaluation of changes in language abilities before and after each rehabilitation protocol - Clinical language assessment 5
Description
Assessment of phonemic discrimination with BALE (Batterie Analytique du Langage Ecrit).
Time Frame
Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Title
Evaluation of changes in language abilities before and after each rehabilitation protocol - Clinical language assessment 6
Description
Assessment of phonological awareness with a rhyme detection task. The patient must decide whether two heard words rhyme or not.
Time Frame
Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Title
Evaluation of changes in cognitive level before and after each rehabilitation protocol - Neuropsychological assessment 1
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.
Time Frame
Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Title
Evaluation of changes in specific executive functions before and after each rehabilitation protocol - Neuropsychological assessment 2
Description
Assessment of visuo-spatial span with the Corsi blocks task.
Time Frame
Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Title
Evaluation of changes in specific executive functions before and after each rehabilitation protocol - Neuropsychological assessment 3
Description
Assessment of non-verbal fluency with the Ruff figural fluency test.
Time Frame
Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Title
Evaluation of changes in specific executive functions before and after each rehabilitation protocol - Neuropsychological assessment 4
Description
Assessment of executive functions with the TMT A-B (Trail Making Test A-B).
Time Frame
Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Title
Evaluation of changes in non-verbal episodic memory before and after each rehabilitation protocol - Neuropsychological assessment 5
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).
Time Frame
Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Title
Evaluation of changes in mental rotation abilities before and after each rehabilitation protocol - Neuropsychological assessment 6
Description
Assessment of mental rotation abilities.
Time Frame
Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Title
Evaluation of mood changes before and after each rehabilitation protocol - Neuropsychological assessment 7
Description
Assessment of depression with Aphasic Depression Rating Scale (ADRS; score out of 32; a score lower than 7 is for "no depression").
Time Frame
Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Title
Evaluation of mood changes before and after each rehabilitation protocol - Neuropsychological assessment 8
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").
Time Frame
Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Title
Neuropsychological assessment 9
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.
Time Frame
Baseline pre-intervention
Title
Evaluation of brain network activation (with measurement of BOLD, Blood Oxygen Level Dependent) before and after rehabilitation - Evaluation-brain 1
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).
Time Frame
Baseline pre-intervention; immediately after the first intervention
Title
Evaluation of brain functional connectivity before and after rehabilitation - Evaluation-brain 2
Description
Assessment of functional connectivity with rs-fMRI (resting state-functional MRI).
Time Frame
Baseline pre-intervention; immediately after the first intervention
Title
Evaluation of brain anatomical connectivity before and after rehabilitation - Evaluation-brain 3
Description
Assessment of diffuse white-matter changes in multiple bundles with MRI-DTI (Diffusion Tension Imaging).
Time Frame
Baseline pre-intervention; immediately after the first intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with late sub-acute and chronic post-stroke (> 4 months) non-fluent aphasia after lesion in the dominant hemisphere for language native speakers of French normal or corrected to normal vision satisfying all criteria for the MRI examination Exclusion Criteria: patients with comprehension deficits, hemi-spatial neglect or upper limb apraxia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
University Hospital, Grenoble
Phone
04 76 76 68 14
Ext
+33
Email
tmontagnon@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica Baciu, MD PhD
Organizational Affiliation
University Hospital, Grenoble & Laboratoire de Psychologie et NeuroCognition
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Grenoble Alpes
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baciu Monica

12. IPD Sharing Statement

Plan to Share IPD
No

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Sensory-Motor Integration for Speech Rehabilitation in Patients With Post-stroke Aphasia

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