Recruiting
Early Phase 1

Speech Treatment

Sponsor:

Teachers College, Columbia University

Code:

NCT06540989

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Immediate treatment

Deferred treatment

Study Details

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

Study ID

NCT06540989

Start date

Sep 1, 2024

Status verified date

Aug, 2024

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jan 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Immediate treatment

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

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.

Interventions

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.

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.

Primary outcome measure

  • Intelligibility [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Gemma Moya-Galé, Ph.D.

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

Locations

Teachers College, Columbia University

Recruiting

New York, New York, United States, 10027

Contacts

Gemma Moya-Galé, Ph.D.

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

More Information

Sponsor

Teachers College, Columbia University

Last update posted

Aug 15, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Teachers College, Columbia University on 2024-08-15.