Noise-augmented Automatic Speech Recognition for Speech Treatment in Parkinson's Disease

August 13, 2024 updated by: Teachers College, Columbia University

Understand Me for Life: Using Noise-augmented Automatic Speech Recognition to Improve Intelligibility in Parkinson's Disease

The goal of this clinical trial is to learn whether noise-augmented feedback using automatic speech recognition improves intelligibility and social participation in individuals with Parkinson's disease. The main questions the investigators will address are:

Does noise-augmented feedback lead to increased intelligibility, as measured by transcription accuracy scores?

Does a self-managed speech protocol lead to increased social participation, as measured by the Communicative Participation Item Bank and the Communicative Effectiveness Index questionnaires?

Participants will:

Receive 2-4 initial speech assessments in-person in our lab. Engage in speech treatment sessions at home using their phone and computer four days a week for four weeks. Four of those sessions will be directly monitored online by a speech-language pathologist. The rest of the sessions are completed by the participant.

Come to the lab for two post-treatment assessments following completion of treatment.

Come to the lab six months after treatment completion for an additional assessment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The goal of this clinical trial is to learn whether noise-augmented feedback using automatic speech recognition improves intelligibility and social participation in individuals with Parkinson's disease.

Data collection will be face-to-face at a convenient time for participants. The screening and assessment sessions will take place in the Communication, Technology, and Language Diversity Lab (Room 952a), on the 9th floor of the 528 Building at Teachers College, Columbia University (525W 120th St, New York, NY 10027).

Treatment sessions will be conducted independently by the participant in the participant's home. Four out of the 16 treatment sessions will be supervised online (via Zoom) by a licensed speech and language pathologist.

The study involves 5-7 assessment sessions (including one 6-month follow-up) and 16 treatment sessions ( = 1 month). Each participant is expected to be involved in the study for 7-8 months.

Participants will first attend a screening session to confirm eligibility, which will involve a hearing screening, a brief cognitive screening, and a brief depression screening. If the screening is successful, participants will complete two or four assessment sessions before initiation of the treatment protocol (the number of assessment sessions depends on their group allocation: immediate treatment or deferred/delayed treatment).

Screenings will only be completed once, during their first in person visit on the Teachers College campus.

In the first assessment session participants will be asked to complete voice recordings and three questionnaires. Participants will complete the same speech tasks and questionnaires in the rest of the assessment sessions. The number of assessment sessions (5 versus 7) depends on whether they are assigned to the immediate treatment group or the delayed treatment group. Group assignments are random, and participants will always receive the treatment protocol.

Each assessment session is estimated to take 60-90 minutes to complete.

Participants will complete the treatment sessions on their own using your phone and computer. Participants will be instructed to find a quiet place at home and practice their exercises at a time when they feel ok and not too tired. They will log in onto our web-based app, Understand Me for Life, to start their speech session. App instructions will be provided during the second assessment session for familiarization purposes.

Each session will contain 20 short sentences (between 3 and 7 words in length). Participants will be asked to try to complete 5 sessions in 1 hour (a total of 100 sentences), taking as many breaks as they may need. Participants will be instructed to complete 1-hour of speech exercises 4 days a week for 4 weeks. The total number of days to participate in the treatment study is 16.

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10027
        • Recruiting
        • Teachers College, Columbia University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants will qualify for the study if:

    • They are 50-80 years old,
    • They have a medical diagnosis of PD,
    • They are within stages I-IV of Hoehn & Yahr Scale,
    • Their antiparkinsonian medication schedule is stable,
    • They present with mild to moderate dysarthria,
    • They score ≥ 25 in the MMSE,
    • They score ≤ 24 in the BDI-III.

Exclusion Criteria:

  • Participants will be excluded from the study if they:

    • Present with atypical parkinsonism at the time of screening (or other neurological condition),
    • Underwent neurosurgery treatment (DBS),
    • Received intensive voice-focused treatment less than three months prior to their involvement in the current study,
    • Present with any speech or voice pathology that is unrelated to PD.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate treatment
Participants will receive speech treatment immediately after their second pre-treatment assessment.
Behavioral: Immediate treatment
Participants will access a web-based app using their phone to record 100 sentences every treatment session. Noise-augmented feedback will be provided to increase accuracy of speech productions.
Active Comparator: Deferred treatment
Participants will receive speech treatment one month after their second pre-treatment assessment. This arm receives the same speech treatment as Arm 1.
Behavioral: Deferred treatment
This group of participants will receive the same treatment as those in the immediate treatment group. The only difference is the timeline of treatment onset. Therefore, participants will access a web-based app using their phone to record 100 sentences every treatment session. Noise-augmented feedback will be provided to increase accuracy of speech productions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intelligibility
Time Frame: 3 years
Transcription accuracy (% words correctly understood by listeners)
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social participation
Time Frame: 7-8 months
Communicative Participation Item Bank questionnaire (10 questions, 0 = very much to 3 = not at all)
7-8 months
Social participation
Time Frame: 7-8 months
Communication Effectiveness Index questionnaire (8 questions, 1 = not at all effective, 4 = very effective)
7-8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teachers College, Columbia University

Collaborators

Temple University

Investigators

  • Principal Investigator: Gemma Moya-Galé, Ph.D., Teachers College, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

July 29, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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