Parkinson DiseaseEarly Phase 1NCT06540989
Noise-augmented Automatic Speech Recognition for Speech Treatment in Parkinson's Disease
A Early Phase 1 study testing Immediate treatment and Deferred treatment in people with Parkinson Disease, run by Teachers College, Columbia University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Immediate treatment and Deferred treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 30 Jun 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Teachers College, Columbia University
New York, New York, 10027
Gemma Moya-Galé, Ph.D., 212-678-3323, gm2446@tc.columbia.edu
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Immediate treatment, Deferred treatment
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate treatmentBehavioural
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.
Deferred treatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate treatment | Experimental | Participants will receive speech treatment immediately after their second pre-treatment assessment. Receives: Behavioral: Immediate treatment |
| Deferred treatment | Active comparator | Participants will receive speech treatment one month after their second pre-treatment assessment. This arm receives the same speech treatment as Arm 1. Receives: Behavioral: Deferred treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intelligibility
Transcription accuracy (% words correctly understood by listeners)
Measured: 3 years
Secondary outcomes (2)
Social participation
Communicative Participation Item Bank questionnaire (10 questions, 0 = very much to 3 = not at all)
Measured: 7-8 months
Social participation
Communication Effectiveness Index questionnaire (8 questions, 1 = not at all effective, 4 = very effective)
Measured: 7-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group of 42 participants with PD will be recruited and randomly assigned to either immediate treatment or deferred treatment. Twenty-one participants will receive treatment immediately after their second pre-treatment assessment. The other 21 participants will receive treatment one month after their second pre-treatment assessment. All participants will receive the same treatment.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teachers College, Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Temple University
- Responsible party
- Sponsor
- Investigators
- Gemma Moya-Galé, Ph.D., Principal investigator, Teachers College, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540989
- Sponsor's protocol ID
- 24-005
- Status last verified
- Aug 2024
- First submitted
- 29 Jul 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understand Me for Life: Using Noise-augmented Automatic Speech Recognition to Improve Intelligibility in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06540989
- Acronym / sponsor ID
- 24-005
- Conditions
- Parkinson Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Teachers College, Columbia UniversityUniversity, hospital or other
- Collaborators
- Temple University
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 7 Aug 2024 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- One group of 42 participants with PD will be recruited and randomly assigned to either immediate treatment or deferred treatment. Twenty-one participants will receive treatment immediately after their second pre-treatment assessment. The other 21 participants will receive treatment one month after their second pre-treatment assessment. All participants will receive the same treatment.
| Arm | Type | Receives |
|---|---|---|
| Immediate treatment | Experimental | Behavioral: Immediate treatmentParticipants will receive speech treatment immediately after their second pre-treatment assessment. |
| Deferred treatment | Active comparator | Behavioral: Deferred treatmentParticipants will receive speech treatment one month after their second pre-treatment assessment. This arm receives the same speech treatment as Arm 1. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants will qualify for the study if:
Key exclusion criteria (5 listed)
- Participants will be excluded from the study if they:
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 |
|---|---|---|
| Immediate treatmentParticipants 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. | Behavioural | Immediate treatment |
| Deferred treatmentThis 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. | Behavioural | Deferred treatment |
Primary outcome
Intelligibility
Time frame: 3 years
Transcription accuracy (% words correctly understood by listeners)
2 secondary outcomes
Social participation
Time frame: 7-8 months
Social participation
Time frame: 7-8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Gemma Moya-Galé, Ph.D. principal investigator
Teachers College, Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Immediate treatment and Deferred treatment in people with Parkinson Disease, run by Teachers College, Columbia University at 1 site in United States.
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 5 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: looking for participants now, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gemma Moya-Galé, Ph.D. (212-678-3323, gm2446@tc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intelligibility (time frame: 3 years). 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 15 Aug 2024.