NCT04630574

Brief 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. This tool is based on a multidimensional and quantified assessment of voice and speech, by a set of targeted acoustic and perceptual criteria.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

February 23, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

3 years

First QC Date

November 1, 2020

Last Update Submit

February 16, 2024

Conditions

Keywords

Huntington's diseaseDysarthriaMotor speech performanceAcoustic markers

Outcome Measures

Primary Outcomes (8)

  • Determination of the intelligibility score.

    Defined as the number of words correctly recognized by the evaluator (score out of 15).

    Day 1

  • Determination of the maximum phonation time.

    Expressed in milliseconds.

    Day 1

  • Determination of the phonation characteristics.

    Described as the mean and standard deviation of fundamental frequency (in Hz),

    Day 1

  • Determination of the intensity modulation capacities.

    Based on a scale of 0 to 4.

    Day 1

  • Determination of the Coarticulation.

    Expressed in Hz. Extracted from the spectral properties of the acoustic signal of certain words.

    Day 1

  • Determination of the prosody.

    assessed on a scale 0 to 4 on particular sentences.

    Day 1

  • Determination of the diadocokinesies,

    assessed on two scales: precision (0 to 4) and control (0 to 4).

    Day 1

  • Determination of the articulation rate.

    expressed in syllabs per second.

    Day 1

Secondary Outcomes (3)

  • Determination of the Huntington's disease stage.

    Day 1

  • Determination of the clinical motor forms of the Huntington's disease.

    Day 1

  • Determination of the level of cognitive impairment

    Day 1

Study Arms (1)

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.

Other: Speech evaluation with the clinical evaluation of dysarthriaOther: complete assessment of the MonPaGe computerized protocol

Interventions

A first speech evaluation with the clinical evaluation of dysarthria during 30 minutes is proposed to exclude very severe dysarthria.

Patients with Huntington's disease

The application records directly and anonymously stores speech productions made by the patient.

Patients with Huntington's disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with Huntington's disease at presymptomatic and declared stages of the disease.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Henri-Mondor

Créteil, France

Location

Centre Hospitalier Universitaire de Bordeaux

Talence, France

Location

MeSH Terms

Conditions

Huntington DiseaseDysarthria

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaChoreaDyskinesiasMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersNeurocognitive DisordersMental DisordersArticulation DisordersSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2020

First Posted

November 16, 2020

Study Start

February 23, 2021

Primary Completion

February 5, 2024

Study Completion

February 5, 2024

Last Updated

February 20, 2024

Record last verified: 2024-02

Locations