Clinical trial NCT04433351: Sensory-Motor Integration for Speech Rehabilitation in Patients with Post-stroke Aphasia
Official title: Evaluation of an Enriched Speech Rehabilitation Program Combining Speech Therapy and Sensory-motor Integration in Aphasic Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aphasia Non Fluent
Stroke
Keywords: post-stroke aphasia
non-fluent aphasia
speech rehabilitation
neuroimaging
neural reorganization
recovery
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Laboratoire de Psychologie et NeuroCognition
name: GIPSA-LAB
First posted: 2020-06-16
Enrollment: 36
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
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

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.

Eligibility criteria: Inclusion Criteria:

* patients with 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

Primary outcomes:
measure: Evaluation of acoustic changes in the speech signal before and after each rehabilitation protocol
timeFrame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Secondary outcomes:
measure: Evaluation of changes in inner speech abilities before and after each rehabilitation protocol - Inner speech testing 1
timeFrame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
measure: Evaluation of changes in inner speech abilities before and after each rehabilitation protocol - Inner speech testing 2
timeFrame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
measure: Clinical language assessment 1a
timeFrame: Baseline pre-intervention
measure: Evaluation of changes in language abilities before and after rehabilitation - Clinical language assessment 1b
timeFrame: Immediately after the first intervention; immediately after the second intervention
measure: Clinical language assessment 2a
timeFrame: Baseline pre-intervention
measure: Evaluation of changes in language abilities before and after rehabilitation - Clinical language assessment 2b
timeFrame: Immediately after the first intervention; immediately after the second intervention
measure: Evaluation of changes in language abilities before and after each rehabilitation protocol - Clinical language assessment 3
timeFrame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
measure: Clinical language assessment 4
timeFrame: Baseline pre-intervention
measure: Evaluation of changes in language abilities before and after each rehabilitation protocol - Clinical language assessment 5
timeFrame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
measure: Evaluation of changes in language abilities before and after each rehabilitation protocol - Clinical language assessment 6
timeFrame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
measure: Evaluation of changes in cognitive level before and after each rehabilitation protocol - Neuropsychological assessment 1
timeFrame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
measure: Evaluation of changes in specific executive functions before and after each rehabilitation protocol - Neuropsychological assessment 2
timeFrame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
measure: Evaluation of changes in specific executive functions before and after each rehabilitation protocol - Neuropsychological assessment 3
timeFrame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
measure: Evaluation of changes in specific executive functions before and after each rehabilitation protocol - Neuropsychological assessment 4
timeFrame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
measure: Evaluation of changes in non-verbal episodic memory before and after each rehabilitation protocol - Neuropsychological assessment 5
timeFrame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
measure: Evaluation of changes in mental rotation abilities before and after each rehabilitation protocol - Neuropsychological assessment 6
timeFrame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
measure: Evaluation of mood changes before and after each rehabilitation protocol - Neuropsychological assessment 7
timeFrame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
measure: Evaluation of mood changes before and after each rehabilitation protocol - Neuropsychological assessment 8
timeFrame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
measure: Neuropsychological assessment 9
timeFrame: Baseline pre-intervention
measure: Evaluation of brain network activation (with measurement of BOLD, Blood Oxygen Level Dependent) before and after rehabilitation - Evaluation-brain 1
timeFrame: Baseline pre-intervention; immediately after the first intervention
measure: Evaluation of brain functional connectivity before and after rehabilitation - Evaluation-brain 2
timeFrame: Baseline pre-intervention; immediately after the first intervention
measure: Evaluation of brain anatomical connectivity before and after rehabilitation - Evaluation-brain 3
timeFrame: Baseline pre-intervention; immediately after the first intervention
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Chu Grenoble Alpes
Study officials:
affiliation: University Hospital, Grenoble & Laboratoire de Psychologie et NeuroCognition
name: Monica Baciu, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: