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

Evaluation of an Enriched Speech Rehabilitation Program Combining Speech Therapy and Sensory-motor Integration in Aphasic Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Aphasia Non Fluent
• Intervention / Treatment: Device: Enriched rehabilitation; Device: Simple rehabilitation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: University Hospital, Grenoble; Phone Number: +33 04 76 76 68 14; Email: tmontagnon@chu-grenoble.fr

Study Locations

• France
  • Grenoble, France, 38043
    • Recruiting
    • CHU Grenoble Alpes
    • Contact: Baciu Monica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SE cohort; Patients in the SE cohort will carry out first the simple rehabilitation protocol (S, 4 weeks) followed by enriched rehabilitation (E, 4 weeks).	Device: Enriched rehabilitation; 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.; Other Names: Sensory-motor integration; Illustration-based rehabilitation method; Device: Simple rehabilitation; 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.; Other Names: Conventional speech therapy
Experimental: ES cohort; Patients in the ES cohort will carry out first the enriched rehabilitation protocol (E, 4 weeks) followed by simple rehabilitation (S, 4 weeks).	Device: Enriched rehabilitation; 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.; Other Names: Sensory-motor integration; Illustration-based rehabilitation method; Device: Simple rehabilitation; 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.; Other Names: Conventional speech therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical language assessment 1a	Assessment of oral and written expression with BDAE (Boston Diagnostic Aphasia Examination).	Baseline pre-intervention
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).	Immediately after the first intervention; immediately after the second intervention
Clinical language assessment 2a	Assessment of transcoding (word/sentence repetition and syllable/word reading) with BDAE (Boston Diagnostic Aphasia Examination).	Baseline pre-intervention
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).	Immediately after the first intervention; immediately after the second intervention
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).	Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Clinical language assessment 4	Assessment of bucco-facial praxia with MT-86 (Montreal-Toulouse aphasia language examination protocol).	Baseline pre-intervention
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).	Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
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.	Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
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.	Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
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.	Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
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.	Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
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).	Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
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).	Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Evaluation of changes in mental rotation abilities before and after each rehabilitation protocol - Neuropsychological assessment 6	Assessment of mental rotation abilities.	Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
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").	Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
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").	Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
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.	Baseline pre-intervention
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).	Baseline pre-intervention; immediately after the first intervention
Evaluation of brain functional connectivity before and after rehabilitation - Evaluation-brain 2	Assessment of functional connectivity with rs-fMRI (resting state-functional MRI).	Baseline pre-intervention; immediately after the first intervention
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).	Baseline pre-intervention; immediately after the first intervention
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	Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
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)	Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: GIPSA-LAB; Laboratoire de Psychologie et NeuroCognition
• Investigators: Principal Investigator: Monica Baciu, MD PhD, University Hospital, Grenoble & Laboratoire de Psychologie et NeuroCognition

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2022
• Primary Completion (Anticipated): May 1, 2026
• Study Completion (Anticipated): May 1, 2026

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: June 12, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: neuroimaging; recovery; non-fluent aphasia; post-stroke aphasia; speech rehabilitation; neural reorganization
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Stroke; Aphasia
• Other Study ID Numbers: 2020-A00720-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No