Aphasia Non FluentSEMONCT04433351
Sensory-Motor Integration for Speech Rehabilitation in Patients With Post-stroke Aphasia
A study testing Enriched rehabilitation and Simple rehabilitation in people with Aphasia Non Fluent and Stroke, run by University Hospital, Grenoble at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Aphasia Non Fluent, Stroke
- What is being tested?
- Enriched rehabilitation and Simple rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2022to 5 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patients with comprehension deficits, hemi-spatial neglect or upper limb apraxia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Grenoble Alpes
Grenoble, 38043
Baciu Monica
About this study
Official title: 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.
Read the 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.
- Conditions
- Aphasia Non Fluent, Stroke
- Being tested
- Enriched rehabilitation, Simple rehabilitation
- Keywords
- post-stroke aphasia, non-fluent aphasia, speech rehabilitation, neuroimaging, neural reorganization, recovery
- Medical subject headings
- Aphasia, Broca, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enriched rehabilitationDevice
Also called Sensory-motor integration, Illustration-based rehabilitation method
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.
Simple rehabilitationDevice
Also called Conventional speech therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| SE cohort | Experimental | Patients in the SE cohort will carry out first the simple rehabilitation protocol (S, 4 weeks) followed by enriched rehabilitation (E, 4 weeks). Receives: Device: Enriched rehabilitation; Device: Simple rehabilitation |
| ES cohort | Experimental | Patients in the ES cohort will carry out first the enriched rehabilitation protocol (E, 4 weeks) followed by simple rehabilitation (S, 4 weeks). Receives: Device: Enriched rehabilitation; Device: Simple rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Secondary outcomes (22)
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
Measured: 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)
Measured: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Clinical language assessment 1a
Assessment of oral and written expression with BDAE (Boston Diagnostic Aphasia Examination).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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").
Measured: 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").
Measured: 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.
Measured: 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 : syllable repetition (repeating a heard syllable), picture-prompted rhyme detection (judging if verbal labels of pictures presented in pairs rhyme or not), and picture naming (naming pictures).
Measured: 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).
Measured: 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).
Measured: Baseline pre-intervention; immediately after the first intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start5 May 2022
- Primary completion5 May 2028 (estimated)
- Study completion5 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphasia Non FluentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire de Psychologie et NeuroCognition, GIPSA-LAB
- Responsible party
- Sponsor
- Investigators
- Monica Baciu, MD PhD, Principal investigator, University Hospital, Grenoble & Laboratoire de Psychologie et NeuroCognition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433351
- Sponsor's protocol ID
- 38RC20.061
- Other IDs
- 2020-A00720-39
- Acronym
- SEMO
- Status last verified
- Sep 2026
- First submitted
- 19 May 2020
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Enriched Speech Rehabilitation Program Combining Speech Therapy and Sensory-motor Integration in Aphasic Patients
- ClinicalTrials.gov ID
- NCT04433351
- Acronym / sponsor ID
- SEMO / 38RC20.061
- Conditions
- Aphasia Non Fluent, Stroke
- Keywords
- post-stroke aphasia, non-fluent aphasia, speech rehabilitation, neuroimaging, neural reorganization, recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Laboratoire de Psychologie et NeuroCognition, GIPSA-LAB
- Study start
- 5 May 2022 (actual)
- Primary completion
- 5 May 2028 (estimated)
- Study completion
- 5 May 2028 (estimated)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| SE cohort | Experimental | Device: Enriched rehabilitation, Device: Simple rehabilitationPatients in the SE cohort will carry out first the simple rehabilitation protocol (S, 4 weeks) followed by enriched rehabilitation (E, 4 weeks). |
| ES cohort | Experimental | Device: Enriched rehabilitation, Device: Simple rehabilitationPatients in the ES cohort will carry out first the enriched rehabilitation protocol (E, 4 weeks) followed by simple rehabilitation (S, 4 weeks). |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- patients with comprehension deficits, hemi-spatial neglect or upper limb apraxia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enriched rehabilitationAlso: Sensory-motor integration, Illustration-based rehabilitation methodThe 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. | Device | ES cohort, SE cohort |
| Simple rehabilitationAlso: Conventional speech therapyThe 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. | Device | ES cohort, SE cohort |
Primary outcome
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
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.
22 secondary outcomes
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
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
Clinical language assessment 1a
Time frame: Baseline pre-intervention
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
Clinical language assessment 2a
Time frame: Baseline pre-intervention
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
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
Clinical language assessment 4
Time frame: Baseline pre-intervention
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
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
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
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
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
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
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
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
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
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
Neuropsychological assessment 9
Time frame: Baseline pre-intervention
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
Evaluation of brain functional connectivity before and after rehabilitation - Evaluation-brain 2
Time frame: Baseline pre-intervention; immediately after the first intervention
Evaluation of brain anatomical connectivity before and after rehabilitation - Evaluation-brain 3
Time frame: Baseline pre-intervention; immediately after the first intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Monica Baciu, MD PhD principal investigator
University Hospital, Grenoble & Laboratoire de Psychologie et NeuroCognition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enriched rehabilitation and Simple rehabilitation in people with Aphasia Non Fluent and Stroke, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact University Hospital, Grenoble (04 76 76 68 14 ext. +33, tmontagnon@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.