Noise-Augmented Speech Therapy for Parkinson's Disease

Overseen By Gemma Moya-Galé, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Teachers College, Columbia University

Must be taking: Antiparkinsonian

Disqualifiers: Atypical parkinsonism, Neurosurgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 22

Duration: 4 weeks

42 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that your Parkinson's medication schedule is stable. This likely means you should continue your current medications without changes.

What data supports the effectiveness of the treatment Noise-augmented Automatic Speech Recognition, Understand Me for Life for Parkinson's Disease?

Research shows that using masking noise can increase voice intensity in Parkinson's patients, which is a common issue. Additionally, automatic speech recognition technology can help measure speech intelligibility in real-life conditions, despite some challenges with noise. ^{1 2 3 4 5}

Is noise-augmented speech therapy safe for humans?

The research does not provide specific safety data for noise-augmented speech therapy, but it does explore the use of technology in speech therapy for Parkinson's disease without reporting any safety concerns. ^{2 3 6 7 8}

How does the Noise-Augmented Speech Therapy treatment differ from other treatments for Parkinson's disease?

Noise-Augmented Speech Therapy is unique because it uses noise-augmented automatic speech recognition technology to help improve speech intelligibility in real-life noisy environments, which is a challenge for people with Parkinson's disease. This approach is different from traditional speech therapies like LSVT LOUD, which focus on increasing vocal volume and articulation without the use of advanced AI technologies. ^{1 2 4 5 9}

What is the purpose of this trial?

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.

Research Team

Gemma Moya-Galé, Ph.D.

Principal Investigator

Teachers College, Columbia University

Eligibility Criteria

This trial is for individuals with Parkinson's Disease who are interested in improving their speech. Participants will need to attend initial and follow-up assessments in a lab, engage in at-home treatment sessions using phone and computer, and be monitored online by a speech therapist.

Inclusion Criteria

Participants scoring ≥ 25 in the MMSE

My Parkinson's medication dose has been stable.

Participants scoring ≤ 24 in the BDI-III

Exclusion Criteria

I have been diagnosed with a form of parkinsonism that is not typical or another neurological condition.

I have undergone deep brain stimulation surgery.

I have not had intensive voice therapy in the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Pre-treatment Assessment

Participants complete 2-4 initial speech assessments in-person

1-2 weeks

2-4 visits (in-person)

Treatment

Participants engage in speech treatment sessions at home using their phone and computer, with some sessions monitored online

4 weeks

16 sessions (home-based, 4 monitored online)

Post-treatment Assessment

Participants come to the lab for two post-treatment assessments

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

1 visit (in-person)

Treatment Details

Interventions

• Noise-augmented Automatic Speech Recognition

Trial Overview The study tests if noise-augmented feedback through automatic speech recognition can help people with Parkinson's speak more clearly (intelligibility) and participate more in social situations. It involves regular home-based treatments over four weeks, plus assessments.

Participant Groups

Group I: Immediate treatment Experimental Treatment 1 Intervention

Participants will receive speech treatment immediately after their second pre-treatment assessment.

Group II: Deferred treatment Active Control 1 Intervention

Participants will receive speech treatment one month after their second pre-treatment assessment. This arm receives the same speech treatment as Arm 1.

Noise-augmented Automatic Speech Recognition is already approved in United States for the following indications:

Approved in United States as Understand Me for Life for:

• Speech treatment for Parkinson's disease

Who Is Running the Clinical Trial?

Teachers College, Columbia University

Lead Sponsor

Trials

27

Recruited

6,100+

Temple University

Collaborator

Trials

321

Recruited

89,100+

Findings from Research

In a study involving 10 patients with Parkinson's disease, the use of white masking noise at 90 dB significantly increased their voice intensity, suggesting a potential new treatment approach.

This method may be particularly beneficial for patients who do not respond well to traditional drug therapies or behavioral speech therapies, especially with the development of portable voice-activated maskers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can the Lombard effect be used to improve low voice intensity in Parkinson's disease? Adams, SG., Lang, AE.[2019]

This pilot study evaluated the performance of Google Cloud speech-to-text technology for recognizing speech from individuals with dysarthria (a speech disorder) compared to healthy speakers, particularly in noisy environments with multi-talker babble.

The findings suggest that while there are challenges in AI performance due to noise, current tools can be used to effectively measure speech intelligibility, indicating potential for developing assistive technologies for people with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automatic Speech Recognition in Noise for Parkinson's Disease: A Pilot Study. Goudarzi, A., Moya-Galé, G.[2022]

In a pilot study involving 9 patients with Parkinson's disease and dysarthria, augmented visual feedback significantly improved the size of articulatory movements during speaking tasks, with 8 out of 9 participants showing increased movement amplitude after training.

The majority of participants were able to retain the learned skill 48 hours after training, indicating that this method could be a feasible approach for enhancing speech in individuals with hypokinetic dysarthria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Game-Based Augmented Visual Feedback for Enlarging Speech Movements in Parkinson's Disease. Yunusova, Y., Kearney, E., Kulkarni, M., et al.[2019]

Individuals with Parkinson's disease (PD) use their voice 50%-60% less in daily life compared to matched healthy controls, with a significant decrease in voice sound level, averaging 8.11 dB lower for females and 6.7 dB lower for males.

The study highlights that environmental noise levels further exacerbate the differences in voice use, suggesting that assessments of voice function should consider real-life situations rather than just controlled clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Voice Use in Daily Life Studied With a Portable Voice Accumulator in Individuals With Parkinson's Disease and Matched Healthy Controls. Gustafsson, JK., Södersten, M., Ternström, S., et al.[2020]

In a randomized control trial with 64 participants with Parkinson's disease, the LSVT LOUD treatment significantly improved speech intelligibility in noisy environments compared to the LSVT ARTIC treatment and no treatment.

The study highlights that focusing on prosodic features, like vocal volume and pitch, through LSVT LOUD can enhance the clarity of speech for individuals with Parkinson's disease, thereby potentially improving their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single Word Intelligibility of Individuals with Parkinson's Disease in Noise: Pre-Specified Secondary Outcome Variables from a Randomized Control Trial (RCT) Comparing Two Intensive Speech Treatments (LSVT LOUD vs. LSVT ARTIC). Schulz, G., Halpern, A., Spielman, J., et al.[2021]

The PD Check-In program, developed as a self-management intervention for people with Parkinson's disease (PD) after LSVT LOUD treatment, showed that participants maintained vocal intensity above pre-treatment levels for up to 24 months, indicating potential long-term benefits for speech maintenance.

While the program had a positive impact on vocal intensity, the psychosocial effects on quality of life varied among participants, suggesting that further evaluation of PD Check-In is needed to fully understand its efficacy and benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PD Check-In: The development and trial of a supported self-management program for people with Parkinson's disease following intensive speech intervention. Finnimore, A., Theodoros, D., Rumbach, AF.[2022]

The PD Check-In model significantly helped maintain vocal intensity in people with Parkinson's disease (PWPD) for up to 24 months after intensive LSVT LOUD treatment, with sustained improvements in vocal intensity measures like maximum sustained phonation.

Participants reported high satisfaction with the PD Check-In program (93.75% for PWPD and 79.99% for communication partners), indicating that the program's benefits extend beyond just acoustic outcomes, supporting their self-management and motivation for speech practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of PD Check-In, a model for supported self-managed maintenance of speech in Parkinson's disease: A Phase 1 study. Finnimore, A., Theodoros, D., Rumbach, AF.[2023]

A study involving 20 participants with Parkinson's disease tested different biofeedback configurations using a portable voice accumulator (VoxLog) to improve vocal loudness during speech.

The optimal configuration for effective feedback was found to be activating when the speaker's volume fell below 3 dB of their average loudness, with a response time of 500 ms, achieving a feedback frequency of 21.2%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor-Learning-Based Adjustment of Ambulatory Feedback on Vocal Loudness for Patients With Parkinson's Disease. Gustafsson, J., Ternström, S., Södersten, M., et al.[2022]

Background noise significantly affects the intelligibility of both disordered (dysarthric) and control speech, but the impact is similar for both types, meaning that increased noise reduces clarity equally regardless of speech disorder.

The study found no interaction between the type of speech and the level of background noise, indicating that dysarthric speech is inherently less intelligible, but the presence of noise does not worsen this effect beyond what is already caused by the speech disorder itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining degradations: The effect of background noise on intelligibility of disordered speech. Yoho, SE., Borrie, SA.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Can the Lombard effect be used to improve low voice intensity in Parkinson's disease? [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Automatic Speech Recognition in Noise for Parkinson's Disease: A Pilot Study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Game-Based Augmented Visual Feedback for Enlarging Speech Movements in Parkinson's Disease. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Voice Use in Daily Life Studied With a Portable Voice Accumulator in Individuals With Parkinson's Disease and Matched Healthy Controls. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Single Word Intelligibility of Individuals with Parkinson's Disease in Noise: Pre-Specified Secondary Outcome Variables from a Randomized Control Trial (RCT) Comparing Two Intensive Speech Treatments (LSVT LOUD vs. LSVT ARTIC). [2021]

6. United States pubmed.ncbi.nlm.nih.gov

PD Check-In: The development and trial of a supported self-management program for people with Parkinson's disease following intensive speech intervention. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Clinical outcomes of PD Check-In, a model for supported self-managed maintenance of speech in Parkinson's disease: A Phase 1 study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Motor-Learning-Based Adjustment of Ambulatory Feedback on Vocal Loudness for Patients With Parkinson's Disease. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Combining degradations: The effect of background noise on intelligibility of disordered speech. [2019]