CAS: Childhood Apraxia of Speech: Experience Dependent Changes Induced by Treatment

Sponsor
IRCCS Fondazione Stella Maris (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04832503
Collaborator
Ministry of Health, Italy (Other)
24
1
46
0.5

Study Details

Study Description

Brief 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 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: PROMPT- treatment
  • Behavioral: LNSOM-treatment

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

  1. 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

Study Type:
Observational
Anticipated Enrollment :
24 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Childhood Apraxia of Speech: Neurobiological and Behavioural Markers and Experience Dependent Changes of Neural Connectivity Induced by Treatment
Actual Study Start Date :
Sep 30, 2018
Anticipated Primary Completion Date :
Jul 30, 2022
Anticipated Study Completion Date :
Jul 30, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

Behavioral: PROMPT- treatment
PROMPTs for Restructuring Oral Muscolar Phonetic Targets

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.

Behavioral: LNSOM-treatment
Language Non-Speech Oral Motor Treatment

Outcome Measures

Primary Outcome Measures

  1. Speech Composite Severity Score changes after 7 months of treatment [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)

Secondary Outcome Measures

  1. Post treatment Diffusion Weighed Imaging (DWI) metrics [At baseline and at 7 months of speech and language training]

    Fractional Anisotropy (FA)

  2. Post treatment Diffusion Weighed Imaging (DWI) changes [At baseline and at 7 months of speech and language training]

    MD (Mean Diffusivity)

  3. Post treatment cortical volumes modifications [At baseline and at 7 months of speech and language training]

    Cortical thickness

  4. Post treatment cortical volumes changes [At baseline and at 7 months of speech and language training]

    Volumes analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 16 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • Orofacial structural abnormalities.

  • Known pathologies of neurological, neurometabolical and genetic etiologies.

  • Audiological deficits.

  • Epilepsy.

  • Intellectual disability.

  • Autism spectrum disorder.

Contacts and Locations

Locations

Site City State Country Postal Code
1 IRCCS Fondazione Stella Maris Marina di Pisa-Tirrenia-Calambrone Toscana Italy 56128

Sponsors and Collaborators

  • IRCCS Fondazione Stella Maris
  • Ministry of Health, Italy

Investigators

  • Principal Investigator: Anna Chilosi, IRCCS Stella Maris Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Anna Chilosi, MD, PhD Head of Neurolinguistic and Neuropsychological Research Laboratory. Coordinator of the Clinical Neuropsichological Unit, IRCCS Fondazione Stella Maris
ClinicalTrials.gov Identifier:
NCT04832503
Other Study ID Numbers:
  • RF-2016-02361560
First Posted:
Apr 5, 2021
Last Update Posted:
Mar 29, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Anna Chilosi, MD, PhD Head of Neurolinguistic and Neuropsychological Research Laboratory. Coordinator of the Clinical Neuropsichological Unit, IRCCS Fondazione Stella Maris
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 29, 2022