DysarthriaHuntingtonNCT03142217
Characterization of the Profile of Dysarthria in Huntington's Disease, Using the Clinical Evaluation Battery of Dysarthria
A study testing Study of dysarthria in patients with Huntington's disease in people with Dysarthria and Huntington Disease, run by Centre Hospitalier Universitaire, Amiens.
Trial summary
Huntington's disease is a hereditary disease of rare autosomal dominant transmission, both neurodegenerative and neuro-psychiatric. Clinically, there are motor symptoms (chorea), cognitive disorders (dementia) and psychiatric disorders. Among motor disorders, dysarthria is a commonly found symptom. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysarthria, Huntington Disease
- What is being tested?
- Study of dysarthria in patients with Huntington's disease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 26 Mar 2015to 1 Mar 2017
- Phase
- Interventional
- 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
Who may be able to join
- Diagnosed Patients HD
- Major Patients
- French-speaking patients
- MMS score greater than 20
- Patients with informed consent signed
- Patients covered by a social insurance system
Who cannot join
- Patients with intercurrent pathologies or other psychiatric disorders that may interfere with battery replacement (at the discretion of the investigator)
- Illiteracy
- Persons placed under safeguard of justice (adults under guardianship or guardianship) or deprived of their liberty
About this study
Huntington's disease is a hereditary disease of rare autosomal dominant transmission, both neurodegenerative and neuro-psychiatric. Clinically, there are motor symptoms (chorea), cognitive disorders (dementia) and psychiatric disorders.
Among motor disorders, dysarthria is a commonly found symptom. This is classically referred to as hyperkinetic dysarthria according to the criteria of Darley's classification. However, this old classification (1969) is only based on perceptual analysis and lack of specificity.
Read more
Moreover, in the course of the disease, chorea (control of the striatal attack D2) decreases to give place to a parkinsonian syndrome (control of the striatal attack D1) and the dysarthria also evolves towards a hypokinetic form . It also seems likely that cerebellar involvement (responsible for ataxia) contributes to dysarthria.
No studies have been published to date to characterize dysarthria in Huntington's disease in a quantified, objective and specific manner. However, Canan Ozsancak describes choreic dysarthria as heterogeneous according to the patients and variable according to the productions. A perceptual study reports an imprecision of the consonants, a lengthening of the pauses, a variable flow, an absence of modulation of the pitch and a hoarse voice.
Finally, few patients are cared for in speech therapy and there is no specific rehabilitation strategy: this would require - and justify a more precise study of the dysarthria of these patients.
The Clinical Evaluation of Dysarthria developed by Pascal Auzou and Véronique Rolland-Monnoury is a recent and partially standardized tool, combining qualitative and quantitative evaluation, which seems adapted to try to better characterize the dysarthria in Huntington's disease.
- Conditions
- Dysarthria, Huntington Disease
- Being tested
- Study of dysarthria in patients with Huntington's disease
- Medical subject headings
- Dysarthria, Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study of dysarthria in patients with Huntington's diseaseOther
Study of dysarthria in patients with Huntington's disease
| Study group | Role | What they receive |
|---|---|---|
| Patient with Huntington's Disease | Other | Not described Receives: Other: Study of dysarthria in patients with Huntington's disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the Clinical Evaluation Battery of Dysarthria using criteria to establish a clinical profile specific to Huntington's disease
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start26 Mar 2015
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Why it stopped: decision of investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysarthriaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142217
- Sponsor's protocol ID
- PI2015_843_0005
- Acronym
- Huntington
- Status last verified
- May 2017
- First submitted
- 3 May 2017
- Last updated
- 5 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Profile of Dysarthria in Huntington's Disease, Using the Clinical Evaluation Battery of Dysarthria
- ClinicalTrials.gov ID
- NCT03142217
- Acronym / sponsor ID
- Huntington / PI2015_843_0005
- Conditions
- Dysarthria, Huntington Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: decision of investigator
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 26 Mar 2015 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 5 May 2017 (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.
Huntington's disease is a hereditary disease of rare autosomal dominant transmission, both neurodegenerative and neuro-psychiatric. Clinically, there are motor symptoms (chorea), cognitive disorders (dementia) and psychiatric disorders.
Among motor disorders, dysarthria is a commonly found symptom. This is classically referred to as hyperkinetic dysarthria according to the criteria of Darley's classification. However, this old classification (1969) is only based on perceptual analysis and lack of specificity.
Moreover, in the course of the disease, chorea (control of the striatal attack D2) decreases to give place to a parkinsonian syndrome (control of the striatal attack D1) and the dysarthria also evolves towards a hypokinetic form . It also seems likely that cerebellar involvement (responsible for ataxia) contributes to dysarthria.
No studies have been published to date to characterize dysarthria in Huntington's disease in a quantified, objective and specific manner. However, Canan Ozsancak describes choreic dysarthria as heterogeneous according to the patients and variable according to the productions. A perceptual study reports an imprecision of the consonants, a lengthening of the pauses, a variable flow, an absence of modulation of the pitch and a hoarse voice.
Finally, few patients are cared for in speech therapy and there is no specific rehabilitation strategy: this would require - and justify a more precise study of the dysarthria of these patients.
The Clinical Evaluation of Dysarthria developed by Pascal Auzou and Véronique Rolland-Monnoury is a recent and partially standardized tool, combining qualitative and quantitative evaluation, which seems adapted to try to better characterize the dysarthria in Huntington's disease.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with Huntington's Disease | Other | Other: Study of dysarthria in patients with Huntington's disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed Patients HD
- Major Patients
- French-speaking patients
- MMS score greater than 20
- Patients with informed consent signed
Key exclusion criteria (3 listed)
- Patients with intercurrent pathologies or other psychiatric disorders that may interfere with battery replacement (at the discretion of the investigator)
- Illiteracy
- Persons placed under safeguard of justice (adults under guardianship or guardianship) or deprived of their liberty
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 |
|---|---|---|
| Study of dysarthria in patients with Huntington's diseaseStudy of dysarthria in patients with Huntington's disease | Other | Patient with Huntington's Disease |
Primary outcome
Analysis of the Clinical Evaluation Battery of Dysarthria using criteria to establish a clinical profile specific to Huntington's disease
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Study of dysarthria in patients with Huntington's disease in people with Dysarthria and Huntington Disease, run by Centre Hospitalier Universitaire, Amiens.
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 6 inclusion and 3 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: withdrawn, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Analysis of the Clinical Evaluation Battery of Dysarthria using criteria to establish a clinical profile specific to Huntington's disease (time frame: 1 day). 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 5 May 2017.