Amyotrophic Lateral Sclerosis Clinical Trial
— SPEECH-ALSOfficial title:
Identification of Acoustic and Perceptual Markers of Lower and Upper Motor Neuron Signs in Dysarthria of Patients With Amyotrophic Lateral Sclerosis : a Comparison With Primitive Lateral Sclerosis, Kennedy's Disease and Controls
Verified date | January 2020 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study proposes to identify acoustic and perceptual markers related to upper motor neuron (UMN) degeneration and lower motor neuron (LMN) degeneration in the dysarthria of patients with amyotrophic lateral sclerosis (ALS) which involves the degeneration of both systems. ALS patients will be gathered in clinical groups according to electromyogram (EMG) and clinical signs observed in the bulbar site. UMN signs are defined as jaw clonus, gag reflex and pseudobulbar features (lability). LMN signs are defined as lingual atrophy and fasciculations. The dysarthria will be compared to dysarthria of patients involving an exclusive UMN system degeneration (in primitive lateral sclerosis) and an exclusive LMN system degeneration (Kennedy's disease). Patients will be compared to the controls who permitted to establish the standards of the "MonPaGe" tool. MonPaGe is a computerized tool based on a multidimensional and quantified assessment of voice and speech, by a set of targeted acoustic and perceptual criteria.
Status | Completed |
Enrollment | 71 |
Est. completion date | December 23, 2019 |
Est. primary completion date | December 23, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Major patients diagnosed at the "centre référent des maladies du motoneurone" with ALS, PLS or KD, - French motherhood language - Mild to moderate severity of dysarthria according to the Perceptual Score of the BECD - Without respiratory troubles according to the neurologist - Without dementia. Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
France | APHP - Hôpital Pitié-Salpêtriere | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Centre National de la Recherche Scientifique, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients in each patterns of dysarthria | Patterns of dysarthria will be determined with post hoc unsupervised machine learning method (cluster analysis) from following measurements: Intelligibility: number of words recognized (score 0 to 15) Maximum phonation time (TMP), (milliseconds), Phonation: mean and standard deviation of fundamental frequency (Hz); jitter (%), shimmer (%);Signal to Noise Ratio (dB) Intensity modulation capacities (score 0 to 4), Articulation of consonants and vowels : global error score (score 0 to 53); qualitative profile of error; acoustic range variation (Hz), Coarticulation (Hz), Score of prosody, Verbal Diadococinesis : accuracy (score 0 to 4) ; control (score 0 to 4) and flow rate (syllables/sec), Speech flow rate (syllables/sec). |
1 day | |
Secondary | Functional scale with the Norris score | The functional capacities of the bulbar site will be evaluated by the speech therapist with the Norris score.This examination will permit to identify UMN and LMN signs | 1 day | |
Secondary | Functional scale with the ALS functional rating scale-R (ALS FRS-R) | The functional capacities of the bulbar site will be evaluated by the speech therapist with the ALS functional rating scale-R (ALS FRS-R). This examination will permit to identify UMN and LMN signs | 1 day | |
Secondary | Severity of the dysarthria | A severity score of the dysarthria will be calculated with the Perceptual Score of the Batterie d'Evaluation Clinique de la Dysarthrie (BECD) | 1 day | |
Secondary | Clinical examination | Classical speech therapy clinical examination | 1 day |
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