Childhood Apraxia of SpeechCASNCT04832503
Childhood Apraxia of Speech: Experience Dependent Changes Induced by Treatment
An observational study of Childhood Apraxia of Speech, run by IRCCS Fondazione Stella Maris at 1 site in Italy.
Trial summary
Childhood Apraxia of Speech (CAS) is a severe speech-language disorder whose aetiological, neuroanatomical correlates are largely unknown. Furthermore, little is known about the neuroplastic effects induced by different treatment approaches and their relationships with the potential changes in the speech behavioural… Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Childhood Apraxia of Speech
- What is being tested?
- PROMPT- treatment and LNSOM-treatment
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 30 Sep 2018to 30 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 4 to 16 years
- All sexes
- Child
Study population: 24 children with idiopathic CAS aged between 4 and 12 years. All the chidren are able to collaborate during MRI acquisition and behavioural assessment and to actively participate in the treatment sessions. To facilitate children's collaboration during MRI execution, a 0 Tesla simulator, reproducing the MRI setting of evaluation will be applied. Moreover during MRI acquisition children will be invited to watch cartoons through special glasses
Who may be able to join
- Diagnosis of idiopathic CAS based on the presence of specific diagnostic features of apraxia of speech (see ASHA and Strand et al's criteria) and on a comprehensive clinical and neurological assessment.
- Non-verbal IQ within the normal range at standardized tests of intelligence.
- Normal structural brain MRI.
- Acquisition of parents' informed consent to the execution of behavoiural and neuroradiological assessment at baseline and to perform speech/language treatment.
Who cannot join
- Orofacial structural abnormalities.
- Known pathologies of neurological, neurometabolical and genetic etiologies.
- Audiological deficits.
- Epilepsy.
- Intellectual disability.
- Autism spectrum disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Childhood Apraxia of Speech: Neurobiological and Behavioural Markers and Experience Dependent Changes of Neural Connectivity Induced by Treatment
Childhood Apraxia of Speech (CAS) is a severe speech-language disorder whose aetiological, neuroanatomical correlates are largely unknown. Furthermore, little is known about the neuroplastic effects induced by different treatment approaches and their relationships with the potential changes in the speech behavioural features that express the core deficit of CAS.
Twenty four children with idiopathic CAS will be enrolled in a multidisciplinary study aimed at analysing the behavioural and neuroanatomical effects of a specific rehabilitative approach, PROMPT (PROMPTs for Restructuring Oral Muscular Phonetic Targets), that employs tactile-kinesthetic-proprioceptive cues vs a traditional speech-language treatment. The children will be allocated in two arms, one receiving a seven month cycle of individual PROMPT treatment, the other a traditional speech and language treatment for the same amount of time.The pre- and post-treatment speech and language performances and DTI and volumetric MR data will be compared in the two groups.
Read the detailed description
Background: Childhood Apraxia of Speech (CAS) is a severe speech-language disorder whose etiological, neuroanatomical and genetic correlates are largely unknown. In this trial the effects of an innovative rehabilitative approach, PROMPT (PROMPTS for Restructuring Oral Muscular Phonetic Targets) will be evaluated from a behavioral and neuroanatomical point of view.
Objective: the current study is aimed to assess speech-language and white matter microstructure and volumetric changes induced by the PROMPT treatment.
Participants: Twenty-two Children with CAS aged 4 -12 years are enrolled and assigned to a PROMPT treatment (PROMPT-t ) or a Language and Non-Speech Oral Motor-treatment group (LNSOM-t).
Methods: All children with CAS will undergo a comprehensive clinical, neurological and speech-language assessment. The following procedures will be applied: a) anamnestic interview b) oral non verbal and verbal movements eveluation c) phonetic inventory, accuracy and consistency of speech d) DDK (Diadochokinetic rate, receptive and expressive vocabulary and grammar tests; f) spontaneous language analysis. These multiple measurements were aggregated and converted into a speech and language composite score.
MRI data will be acquired using a 1.5 T MR scanner. Structural images obtained with a 3D isotropic T1 weighted sequence will be analysed to evaluate volumetric alterations, to investigate cortical thickness and automatically delineate various Regions of Interest (ROIs). HARDI images will be acquired using 32 gradient directions and will be processed using tools available in FSL and MRtrix. Tract-based spatial statistics (TBSS) will be used to statistically analyse images of FA and mean diffusivity. Fiber tracts will be calculated using constrained spherical deconvolution and probabilistic tractography. Connectomes will be calculated by combining ROIs obtained from the structural images with tractography. Network-based analysis will be used to statistically analyse connectomes.
Speech and language assessment and brain MRI VBM and DTI analysis will be performed at baseline and at the end of the treatment.
Statistical analysis: Paired t-test on pre and post treatment behavioural and MRI/DTI measures will be performed to assess the changes within each of the two groups. Moreover, comparisons between the two groups at T0 and T1 will be performed by means of non parametric tests.
Evaluation of potentially training-induced changes of brain structural connectivity may provide further support to the hypothesis that CAS is due to a disruption of networks subserving the speech production system.
- Conditions
- Childhood Apraxia of Speech
- Being tested
- PROMPT- treatment, LNSOM-treatment
- Keywords
- Treatment induced speech changes, PROMPT, MRI, Neuroplasticity
- Medical subject headings
- Apraxias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROMPT- treatmentBehavioural
PROMPTs for Restructuring Oral Muscolar Phonetic Targets
LNSOM-treatmentBehavioural
Language Non-Speech Oral Motor Treatment
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | The PROMPT-treated group will include 12 children with idiopathic CAS. The pre-treatment assessment is aimed at evaluating the baseline speech and language level and at treatment planning. During a PROMPT session tactile-kinesthetic-proprioceptive inputs are consistently provided in order to shape speech movements, to give information on sequencing and timing, and to introduce constraints for the reduction of the degrees of freedom at the articulators' level in favour of motor control. In a PROMPT session the syllables, words and phrases are produced within a communicative context in play. Speech motor goals are, as soon as possible, integrated in goals for language and functional communication. Receives: Behavioral: PROMPT- treatment | |
| GROUP 2 | The LNSOM-treated group will include 12 children with idiopathic CAS. The pre-treatment assessment is aimed at evaluating the baseline speech and language level and at the treatment planning. None of the SLTs treating this group are PROMPT trained. According to the standard care methods used in Italy, the intervention consists of a linguistic and articulatory approach that includes auditory discrimination of phonemic categories at the syllable and word level and non-speech oral motor exercises. Receptive and expressive lexicon and morphosyntax are targeted depending on the children's linguistic profile.Differently from the PROMPT, selection of speech sounds to be targeted, is based on developmental speech sounds acquisition rather than motor criteria. According to this treatment approach, the motor goal is usually identified with the placement of the main articulator involved in the production of a speech sound. Receives: Behavioral: LNSOM-treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Composite Severity Score changes after 7 months of treatment
Speech Severity Score aggregates measures of DDK, inaccuracy, inconsistency, Phonetic inventory, Syllable Omissions. Score ranges form: 0 (normal) to 5 (severely impaired)
Measured: At baselin and at 7 months of individual speech and language training
Secondary outcomes (4)
Post treatment Diffusion Weighed Imaging (DWI) metrics
Fractional Anisotropy (FA)
Measured: At baseline and at 7 months of speech and language training
Post treatment Diffusion Weighed Imaging (DWI) changes
MD (Mean Diffusivity)
Measured: At baseline and at 7 months of speech and language training
Post treatment cortical volumes modifications
Cortical thickness
Measured: At baseline and at 7 months of speech and language training
Post treatment cortical volumes changes
Volumes analysis
Measured: At baseline and at 7 months of speech and language training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start30 Sep 2018
- Primary completion30 Jan 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Childhood Apraxia of SpeechStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Fondazione Stella Maris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy
- Responsible party
- Principal investigator, Anna Chilosi, IRCCS Fondazione Stella Maris
- Investigators
- Anna Chilosi, Principal investigator, IRCCS Stella Maris Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832503
- Sponsor's protocol ID
- RF-2016-02361560
- Acronym
- CAS
- Status last verified
- Oct 2023
- First submitted
- 20 Feb 2021
- Last updated
- 24 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The results of each individual participant's evaluations will be coded and entered in a computerized database. Descriptive statistical analyses may be shared with other researchers on request .
Publications
Kadis DS, Goshulak D, Namasivayam A, Pukonen M, Kroll R, De Nil LF, Pang EW, Lerch JP. Cortical thickness in children receiving intensive therapy for idiopathic apraxia of speech. Brain Topogr. 2014 Mar;27(2):240-7. doi: 10.1007/s10548-013-0308-8. Epub 2013 Aug 24.
PubMed 23974724Fiori S, Guzzetta A, Mitra J, Pannek K, Pasquariello R, Cipriani P, Tosetti M, Cioni G, Rose SE, Chilosi A. Neuroanatomical correlates of childhood apraxia of speech: A connectomic approach. Neuroimage Clin. 2016 Nov 4;12:894-901. doi: 10.1016/j.nicl.2016.11.003. eCollection 2016.
PubMed 27882295Square PA, Namasivayam AK, Bose A, Goshulak D, Hayden D. Multi-sensory treatment for children with developmental motor speech disorders. Int J Lang Commun Disord. 2014 Sep-Oct;49(5):527-42. doi: 10.1111/1460-6984.12083. Epub 2014 Mar 12. No abstract available.
PubMed 24617702Morgan AT, Su M, Reilly S, Conti-Ramsden G, Connelly A, Liegeois FJ. A Brain Marker for Developmental Speech Disorders. J Pediatr. 2018 Jul;198:234-239.e1. doi: 10.1016/j.jpeds.2018.02.043. Epub 2018 Apr 25.
PubMed 29705112Dale PS, Hayden DA. Treating speech subsystems in childhood apraxia of speech with tactual input: the PROMPT approach. Am J Speech Lang Pathol. 2013 Nov;22(4):644-61. doi: 10.1044/1058-0360(2013/12-0055). Epub 2013 Jun 28.
PubMed 23813194Namasivayam AK, Huynh A, Granata F, Law V, van Lieshout P. PROMPT intervention for children with severe speech motor delay: a randomized control trial. Pediatr Res. 2021 Feb;89(3):613-621. doi: 10.1038/s41390-020-0924-4. Epub 2020 May 1.
PubMed 32357364
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Apraxia of Speech: Neurobiological and Behavioural Markers and Experience Dependent Changes of Neural Connectivity Induced by Treatment
- ClinicalTrials.gov ID
- NCT04832503
- Acronym / sponsor ID
- CAS / RF-2016-02361560
- Conditions
- Childhood Apraxia of Speech
- Keywords
- Treatment induced speech changes, PROMPT, MRI, Neuroplasticity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- IRCCS Fondazione Stella MarisUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy
- Study start
- 30 Sep 2018 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 5 Apr 2021 (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.
Childhood Apraxia of Speech (CAS) is a severe speech-language disorder whose aetiological, neuroanatomical correlates are largely unknown. Furthermore, little is known about the neuroplastic effects induced by different treatment approaches and their relationships with the potential changes in the speech behavioural features that express the core deficit of CAS.
Twenty four children with idiopathic CAS will be enrolled in a multidisciplinary study aimed at analysing the behavioural and neuroanatomical effects of a specific rehabilitative approach, PROMPT (PROMPTs for Restructuring Oral Muscular Phonetic Targets), that employs tactile-kinesthetic-proprioceptive cues vs a traditional speech-language treatment. The children will be allocated in two arms, one receiving a seven month cycle of individual PROMPT treatment, the other a traditional speech and language treatment for the same amount of time.The pre- and post-treatment speech and language performances and DTI and volumetric MR data will be compared in the two groups.
Detailed description
Background: Childhood Apraxia of Speech (CAS) is a severe speech-language disorder whose etiological, neuroanatomical and genetic correlates are largely unknown. In this trial the effects of an innovative rehabilitative approach, PROMPT (PROMPTS for Restructuring Oral Muscular Phonetic Targets) will be evaluated from a behavioral and neuroanatomical point of view.
Objective: the current study is aimed to assess speech-language and white matter microstructure and volumetric changes induced by the PROMPT treatment.
Participants: Twenty-two Children with CAS aged 4 -12 years are enrolled and assigned to a PROMPT treatment (PROMPT-t ) or a Language and Non-Speech Oral Motor-treatment group (LNSOM-t).
Methods: All children with CAS will undergo a comprehensive clinical, neurological and speech-language assessment. The following procedures will be applied: a) anamnestic interview b) oral non verbal and verbal movements eveluation c) phonetic inventory, accuracy and consistency of speech d) DDK (Diadochokinetic rate, receptive and expressive vocabulary and grammar tests; f) spontaneous language analysis. These multiple measurements were aggregated and converted into a speech and language composite score.
MRI data will be acquired using a 1.5 T MR scanner. Structural images obtained with a 3D isotropic T1 weighted sequence will be analysed to evaluate volumetric alterations, to investigate cortical thickness and automatically delineate various Regions of Interest (ROIs). HARDI images will be acquired using 32 gradient directions and will be processed using tools available in FSL and MRtrix. Tract-based spatial statistics (TBSS) will be used to statistically analyse images of FA and mean diffusivity. Fiber tracts will be calculated using constrained spherical deconvolution and probabilistic tractography. Connectomes will be calculated by combining ROIs obtained from the structural images with tractography. Network-based analysis will be used to statistically analyse connectomes.
Speech and language assessment and brain MRI VBM and DTI analysis will be performed at baseline and at the end of the treatment.
Statistical analysis: Paired t-test on pre and post treatment behavioural and MRI/DTI measures will be performed to assess the changes within each of the two groups. Moreover, comparisons between the two groups at T0 and T1 will be performed by means of non parametric tests.
Evaluation of potentially training-induced changes of brain structural connectivity may provide further support to the hypothesis that CAS is due to a disruption of networks subserving the speech production system.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Behavioral: PROMPT- treatmentThe PROMPT-treated group will include 12 children with idiopathic CAS. The pre-treatment assessment is aimed at evaluating the baseline speech and language level and at treatment planning. During a PROMPT session tactile-kinesthetic-proprioceptive inputs are consistently provided in order to shape speech movements, to give information on sequencing and timing, and to introduce constraints for the reduction of the degrees of freedom at the articulators' level in favour of motor control. In a PROMPT session the syllables, words and phrases are produced within a communicative context in play. Speech motor goals are, as soon as possible, integrated in goals for language and functional communication. |
| GROUP 2 | – | Behavioral: LNSOM-treatmentThe LNSOM-treated group will include 12 children with idiopathic CAS. The pre-treatment assessment is aimed at evaluating the baseline speech and language level and at the treatment planning. None of the SLTs treating this group are PROMPT trained. According to the standard care methods used in Italy, the intervention consists of a linguistic and articulatory approach that includes auditory discrimination of phonemic categories at the syllable and word level and non-speech oral motor exercises. Receptive and expressive lexicon and morphosyntax are targeted depending on the children's linguistic profile.Differently from the PROMPT, selection of speech sounds to be targeted, is based on developmental speech sounds acquisition rather than motor criteria. According to this treatment approach, the motor goal is usually identified with the placement of the main articulator involved in the production of a speech sound. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- 24 children with idiopathic CAS aged between 4 and 12 years. All the chidren are able to collaborate during MRI acquisition and behavioural assessment and to actively participate in the treatment sessions. To facilitate children's collaboration during MRI execution, a 0 Tesla simulator, reproducing the MRI setting of evaluation will be applied. Moreover during MRI acquisition children will be invited to watch cartoons through special glasses
Key inclusion criteria (4 listed)
- Diagnosis of idiopathic CAS based on the presence of specific diagnostic features of apraxia of speech (see ASHA and Strand et al's criteria) and on a comprehensive clinical and neurological assessment.
- Non-verbal IQ within the normal range at standardized tests of intelligence.
- Normal structural brain MRI.
- Acquisition of parents' informed consent to the execution of behavoiural and neuroradiological assessment at baseline and to perform speech/language treatment.
Key exclusion criteria (6 listed)
- Orofacial structural abnormalities.
- Known pathologies of neurological, neurometabolical and genetic etiologies.
- Audiological deficits.
- Epilepsy.
- Intellectual disability.
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 |
|---|---|---|
| PROMPT- treatmentPROMPTs for Restructuring Oral Muscolar Phonetic Targets | Behavioural | Group 1 |
| LNSOM-treatmentLanguage Non-Speech Oral Motor Treatment | Behavioural | GROUP 2 |
Primary outcome
Speech Composite Severity Score changes after 7 months of treatment
Time frame: At baselin and at 7 months of individual speech and language training
Speech Severity Score aggregates measures of DDK, inaccuracy, inconsistency, Phonetic inventory, Syllable Omissions. Score ranges form: 0 (normal) to 5 (severely impaired)
4 secondary outcomes
Post treatment Diffusion Weighed Imaging (DWI) metrics
Time frame: At baseline and at 7 months of speech and language training
Post treatment Diffusion Weighed Imaging (DWI) changes
Time frame: At baseline and at 7 months of speech and language training
Post treatment cortical volumes modifications
Time frame: At baseline and at 7 months of speech and language training
Post treatment cortical volumes changes
Time frame: At baseline and at 7 months of speech and language training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Background: PubMed 23974724Kadis DS, Goshulak D, Namasivayam A, Pukonen M, Kroll R, De Nil LF, Pang EW, Lerch JP. Cortical thickness in children receiving intensive therapy for idiopathic apraxia of speech. Brain Topogr. 2014 Mar;27(2):240-7. doi: 10.1007/s10548-013-0308-8. Epub 2013 Aug 24.
- Background: PubMed 27882295Fiori S, Guzzetta A, Mitra J, Pannek K, Pasquariello R, Cipriani P, Tosetti M, Cioni G, Rose SE, Chilosi A. Neuroanatomical correlates of childhood apraxia of speech: A connectomic approach. Neuroimage Clin. 2016 Nov 4;12:894-901. doi: 10.1016/j.nicl.2016.11.003. eCollection 2016.
- Background: PubMed 24617702Square PA, Namasivayam AK, Bose A, Goshulak D, Hayden D. Multi-sensory treatment for children with developmental motor speech disorders. Int J Lang Commun Disord. 2014 Sep-Oct;49(5):527-42. doi: 10.1111/1460-6984.12083. Epub 2014 Mar 12. No abstract available.
- Background: PubMed 29705112Morgan AT, Su M, Reilly S, Conti-Ramsden G, Connelly A, Liegeois FJ. A Brain Marker for Developmental Speech Disorders. J Pediatr. 2018 Jul;198:234-239.e1. doi: 10.1016/j.jpeds.2018.02.043. Epub 2018 Apr 25.
- Background: PubMed 23813194Dale PS, Hayden DA. Treating speech subsystems in childhood apraxia of speech with tactual input: the PROMPT approach. Am J Speech Lang Pathol. 2013 Nov;22(4):644-61. doi: 10.1044/1058-0360(2013/12-0055). Epub 2013 Jun 28.
- Background: PubMed 32357364Namasivayam AK, Huynh A, Granata F, Law V, van Lieshout P. PROMPT intervention for children with severe speech motor delay: a randomized control trial. Pediatr Res. 2021 Feb;89(3):613-621. doi: 10.1038/s41390-020-0924-4. Epub 2020 May 1.
- Individual participant dataSharing planned: Undecided. The results of each individual participant's evaluations will be coded and entered in a computerized database. Descriptive statistical analyses may be shared with other researchers on request .
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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. This study is not recruiting at the moment.
Anna Chilosi principal investigator
IRCCS Stella Maris Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Apraxia of Speech, run by IRCCS Fondazione Stella Maris at 1 site in Italy.
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 6 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: finished, as of the sponsor's last update on 24 Oct 2023. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech Composite Severity Score changes after 7 months of treatment (time frame: At baselin and at 7 months of individual speech and language training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04832503, which also lists 6 linked publications.
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 24 Oct 2023.