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

NCT06540989 | Recruiting Early Phase 1

• 1 other identifier: 24-005
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Intelligibility

  Transcription accuracy (% words correctly understood by listeners)

  3 years

Secondary Outcomes (2)

• Social participation

  7-8 months

• Social participation

  7-8 months

Study Arms (2)

Immediate treatment

EXPERIMENTAL

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

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.

Behavioral: Deferred treatment

Interventions

Immediate treatment BEHAVIORAL

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.

Immediate treatment

Deferred treatment BEHAVIORAL

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.

Deferred treatment

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teachers College, Columbia University: lead
• Temple University: collaborator

Study Sites (1)

Teachers College, Columbia University

New York, New York, 10027, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Gemma Moya-Galé, Ph.D.

  Teachers College, Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gemma Moya-Galé, Ph.D.

CONTACT

212-678-3323; gm2446@tc.columbia.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 7, 2024
• Study Start: September 1, 2024
• Primary Completion: January 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)