Huntington DiseaseTPMHNCT04630574
Characterization and Quantification of Motor Speech Disorders in Huntington's Disease: Identification of Acoustic Markers
An observational study of Huntington Disease, run by University Hospital, Bordeaux at 2 sites in France.
Trial summary
The study proposes to identify deviant speech dimensions in patients with HD at presymptomatic and declared stages of the disease, compared to healthy subjects, using the computerized MonPaGe speech protocol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Huntington Disease
- What is being tested?
- Speech evaluation with the clinical evaluation of dysarthria and complete assessment of the MonPaGe computerized protocol
- How many people
- 150 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Feb 2021to 5 Feb 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with Huntington's disease at presymptomatic and declared stages of the disease.
Who may be able to join
- major patients
- francophone patients
- Huntington's disease carriers confirmed by molecular biological analysis
- carriers of pre-symptomatic Huntington's disease: Total Motor Score of the Unified Huntington's Disease Rating Scale <5
- carriers of Huntington's disease at a declared stage: Total Motor Score of the Unified Huntington's Disease Rating Scale ≥ 5
- followed in the Competence Center Huntington's disease Bordeaux Hospital or in the Reference Center Huntington's disease Henri Mondor Hospital of Créteil
- affiliates or beneficiaries of a social security scheme
- Finally, a free, informed and express consent of the patient must be collected.
Who cannot join
- Huntington's disease patients with severe dysarthria (BECD score> 16), acoustic analysis not being possible on unintelligible speech
- patients placed under the protection of justice
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Henri-Mondor
Créteil
Centre Hospitalier Universitaire de Bordeaux
Talence
About this study
The study proposes to identify deviant speech dimensions in patients with HD at presymptomatic and declared stages of the disease, compared to healthy subjects, using the computerized MonPaGe speech protocol. This tool is based on a multidimensional and quantified assessment of voice and speech, by a set of targeted acoustic and perceptual criteria.
Read the detailed description
Huntington's disease (HD) is a neurodegenerative disorder of the central nervous system, of genetic etiology. It manifests itself in motor, cognitive and psychiatric disorders, which progressively worsen until the patient is grabbed. Motor speech performance disorders are present from the early stage of the disease. These difficulties, which progressively worsen until the end of the patient's life, lead to a communication disorder and constitute a major handicap with social withdrawal, loss of self-esteem and isolation, which are always very painfully experienced by patients and their entourage. Dysarthria in the HD has been very little studied, which makes its speech therapy uncodified. According to the most widely used classification by speech therapists and neurologists, the Darley classification (1975), the speech disorders observed in the HD are included in the heterogeneous group of hyperkinetic dysarthria, whose contours and properties are ill-defined. In this context, a more precise knowledge of speech disorders in the HD appears necessary to identify and characterize the different types of dysarthria and the dysfunctions associated with each level of production (respiration, phonation, resonance, articulation, prosody) and thus improve speech language therapy.
The investigators propose to use an acoustic evaluation to support the perceptual evaluation, available in the MonPaGe protocol, to describe the fine characteristics of the speech disorders in the HD and to define objective markers of dysarthria in this disease for francophone patients.
Each patient is seen in the framework of his annual follow-up consultation in the Competence Center mdH of Bordeaux University Hospital or in the Reference Center mdH of the hospital Henri Mondor of Créteil, for an evaluation of his speech with the computerized tool MonPaGe. A first speech evaluation with the BECD (Auzou, 2006) during 30 minutes is proposed to exclude very severe dysarthria. At the end of this rapid test subtest, the subjects who obtain a perceptive score <16 are offered the complete assesment of the MonPaGe computerized protocol (30 minutes).The application records directly and anonymously stores speech productions made by the patient.The productions are transmitted to the Phonetics and Phonology Laboratory of Paris (UMR 7018 CNRS / Sorbonne Nouvelle), via a secure large data exchange server and are subject to a perceptual and acoustic evaluation a posteriori.
- Conditions
- Huntington Disease
- Being tested
- Speech evaluation with the clinical evaluation of dysarthria, complete assessment of the MonPaGe computerized protocol
- Keywords
- Huntington's disease, Dysarthria, Motor speech performance, Acoustic markers
- Medical subject headings
- Huntington Disease, Dysarthria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech evaluation with the clinical evaluation of dysarthriaOther
A first speech evaluation with the clinical evaluation of dysarthria during 30 minutes is proposed to exclude very severe dysarthria.
complete assessment of the MonPaGe computerized protocolOther
The application records directly and anonymously stores speech productions made by the patient.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Huntington's disease | Each patient is seen in the framework of his annual follow-up consultation, for an evaluation of his speech with the computerized tool MonPaGe. Receives: Other: Speech evaluation with the clinical evaluation of dysarthria; Other: complete assessment of the MonPaGe computerized protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the intelligibility score.
Defined as the number of words correctly recognized by the evaluator (score out of 15).
Measured: Day 1
Determination of the maximum phonation time.
Expressed in milliseconds.
Measured: Day 1
Determination of the phonation characteristics.
Described as the mean and standard deviation of fundamental frequency (in Hz),
Measured: Day 1
Determination of the intensity modulation capacities.
Based on a scale of 0 to 4.
Measured: Day 1
Determination of the Coarticulation.
Expressed in Hz. Extracted from the spectral properties of the acoustic signal of certain words.
Measured: Day 1
Determination of the prosody.
assessed on a scale 0 to 4 on particular sentences.
Measured: Day 1
Determination of the diadocokinesies,
assessed on two scales: precision (0 to 4) and control (0 to 4).
Measured: Day 1
Determination of the articulation rate.
expressed in syllabs per second.
Measured: Day 1
Secondary outcomes (3)
Determination of the Huntington's disease stage.
The Huntington's disease stage will be determined based on the Total Functional Capacity (TFC) and the Total Motor Score (TMS) scales of the Unified Huntington's Disease Rating Scale:
- pre-symptomatic stage: TFC = 13 / TMS <5
- light stage: TFC ≥11 / TMS 5 to 20
- moderate stage: TFC = 7 to 10 / TMS: 20 to 40
Measured: Day 1
Determination of the clinical motor forms of the Huntington's disease.
The clinical motor forms of Huntington disease will be determined by the motor UHDRS scale (Total Motor Score), which evaluates oculomotricity, skill and manual planning, bradykinesia, dystonia and rigidity, chorea and walking, balance, lingual protrusion and dysarthria.
Measured: Day 1
Determination of the level of cognitive impairment
The level of cognitive impairment will be assessed by the cognitive score as per the Unified Huntington's Disease Rating Scale.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start23 Feb 2021
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630574
- Sponsor's protocol ID
- CHUBX 2018/67
- Acronym
- TPMH
- Status last verified
- Feb 2024
- First submitted
- 1 Nov 2020
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Quantification of Motor Speech Disorders in Huntington's Disease: Identification of Acoustic Markers
- ClinicalTrials.gov ID
- NCT04630574
- Acronym / sponsor ID
- TPMH / CHUBX 2018/67
- Conditions
- Huntington Disease
- Keywords
- Huntington's disease, Dysarthria, Motor speech performance, Acoustic markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 16 Nov 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.
The study proposes to identify deviant speech dimensions in patients with HD at presymptomatic and declared stages of the disease, compared to healthy subjects, using the computerized MonPaGe speech protocol. This tool is based on a multidimensional and quantified assessment of voice and speech, by a set of targeted acoustic and perceptual criteria.
Detailed description
Huntington's disease (HD) is a neurodegenerative disorder of the central nervous system, of genetic etiology. It manifests itself in motor, cognitive and psychiatric disorders, which progressively worsen until the patient is grabbed. Motor speech performance disorders are present from the early stage of the disease. These difficulties, which progressively worsen until the end of the patient's life, lead to a communication disorder and constitute a major handicap with social withdrawal, loss of self-esteem and isolation, which are always very painfully experienced by patients and their entourage. Dysarthria in the HD has been very little studied, which makes its speech therapy uncodified. According to the most widely used classification by speech therapists and neurologists, the Darley classification (1975), the speech disorders observed in the HD are included in the heterogeneous group of hyperkinetic dysarthria, whose contours and properties are ill-defined. In this context, a more precise knowledge of speech disorders in the HD appears necessary to identify and characterize the different types of dysarthria and the dysfunctions associated with each level of production (respiration, phonation, resonance, articulation, prosody) and thus improve speech language therapy.
The investigators propose to use an acoustic evaluation to support the perceptual evaluation, available in the MonPaGe protocol, to describe the fine characteristics of the speech disorders in the HD and to define objective markers of dysarthria in this disease for francophone patients.
Each patient is seen in the framework of his annual follow-up consultation in the Competence Center mdH of Bordeaux University Hospital or in the Reference Center mdH of the hospital Henri Mondor of Créteil, for an evaluation of his speech with the computerized tool MonPaGe. A first speech evaluation with the BECD (Auzou, 2006) during 30 minutes is proposed to exclude very severe dysarthria. At the end of this rapid test subtest, the subjects who obtain a perceptive score <16 are offered the complete assesment of the MonPaGe computerized protocol (30 minutes).The application records directly and anonymously stores speech productions made by the patient.The productions are transmitted to the Phonetics and Phonology Laboratory of Paris (UMR 7018 CNRS / Sorbonne Nouvelle), via a secure large data exchange server and are subject to a perceptual and acoustic evaluation a posteriori.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Huntington's disease | – | Other: Speech evaluation with the clinical evaluation of dysarthria, Other: complete assessment of the MonPaGe computerized protocolEach patient is seen in the framework of his annual follow-up consultation, for an evaluation of his speech with the computerized tool MonPaGe. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with Huntington's disease at presymptomatic and declared stages of the disease.
Key inclusion criteria (8 listed)
- major patients
- francophone patients
- Huntington's disease carriers confirmed by molecular biological analysis
- carriers of pre-symptomatic Huntington's disease: Total Motor Score of the Unified Huntington's Disease Rating Scale <5
- carriers of Huntington's disease at a declared stage: Total Motor Score of the Unified Huntington's Disease Rating Scale ≥ 5
Key exclusion criteria (2 listed)
- Huntington's disease patients with severe dysarthria (BECD score> 16), acoustic analysis not being possible on unintelligible speech
- patients placed under the protection of justice
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 |
|---|---|---|
| Speech evaluation with the clinical evaluation of dysarthriaA first speech evaluation with the clinical evaluation of dysarthria during 30 minutes is proposed to exclude very severe dysarthria. | Other | Patients with Huntington's disease |
| complete assessment of the MonPaGe computerized protocolThe application records directly and anonymously stores speech productions made by the patient. | Other | Patients with Huntington's disease |
Primary outcome
Determination of the intelligibility score.
Time frame: Day 1
Defined as the number of words correctly recognized by the evaluator (score out of 15).
Determination of the maximum phonation time.
Time frame: Day 1
Expressed in milliseconds.
Determination of the phonation characteristics.
Time frame: Day 1
Described as the mean and standard deviation of fundamental frequency (in Hz),
Determination of the intensity modulation capacities.
Time frame: Day 1
Based on a scale of 0 to 4.
Determination of the Coarticulation.
Time frame: Day 1
Expressed in Hz. Extracted from the spectral properties of the acoustic signal of certain words.
Determination of the prosody.
Time frame: Day 1
assessed on a scale 0 to 4 on particular sentences.
Determination of the diadocokinesies,
Time frame: Day 1
assessed on two scales: precision (0 to 4) and control (0 to 4).
Determination of the articulation rate.
Time frame: Day 1
expressed in syllabs per second.
3 secondary outcomes
Determination of the Huntington's disease stage.
Time frame: Day 1
Determination of the clinical motor forms of the Huntington's disease.
Time frame: Day 1
Determination of the level of cognitive impairment
Time frame: Day 1
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 20 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Huntington Disease, run by University Hospital, Bordeaux at 2 sites 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 8 inclusion and 2 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 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Determination of the intelligibility score. (time frame: Day 1). The study lists 8 primary outcomes in all. 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 20 Feb 2024.