- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07403539
파킨슨병의 언어 학습과 언어 생성
파킨슨병에서 말 지각 학습과 말 생산 간의 관계
Parkinson's disease, a common movement disorder that results from a breakdown in the brain, often leads to challenges with talking, but less is known about the relationship between difficulties with talking and difficulties with learning to understand speech. By linking these two abilities in individuals with Parkinson's disease using a precision medicine approach, this project seeks to build a basis for new therapies that help people with Parkinson's disease both understand better and speak more clearly.
연구 개요
상태
정황
상세 설명
In the context of speech-language therapy, Parkinson's disease (PD) is typically associated with its consequences on speech production. Interventions generally focus on learning or relearning skills to accomplish successful production. However, the disease itself, as well as patient responses to interventions, are variable. Individuals differ widely in how typical their speech output is before intervention and in how much they learn from treatment. One plausible explanation for this variation comes from a less-studied aspect of speech and language in PD: speech perception, especially speech perceptual learning. There is a key gap in the PD literature about whether people who produce atypical rate and intensity properties in their own speech also find it more difficult to learn rate and intensity properties from others' speech. There is, therefore, a critical need for a full understanding of the relationship between speech production and speech perceptual learning in PD. The long- term goal of this research program is to systematically interrogate the relationship between speech learning and production in people with PD and to leverage that knowledge to promote effective communication. The overall objective of this project is to use acoustic measures to determine how challenges with speech perception or learning can predict individual differences in speech production. The central hypothesis is that individual differences between people with PD in speech perception or learning can predict individual differences between people with PD in speech production. This project adopts an individual differences approach to investigate two major aims: (1) relating individual differences in the perceptual learning of speech rate to the production of speech rate, and (2) relating individual differences in the perceptual learning of intensity to the production of intensity. To investigate these aims, each participant will record a speech sample and conduct tasks that involve learning regularities in rate or intensity in the speech of others. Participants will also complete tasks that require the ability to distinguish between sentences based on their rate and intensity. Participants' speech samples will additionally be judged by naive listeners to assess the samples' intelligibility and the effort that it takes to understand the speakers. If individual differences in perceptual learning predict individual differences in production, then differences in speech perception may predict differences in speech-language therapy outcomes that could be targeted to patient needs. A precision medicine approach would allow for interventions that titrate the amount, level, and type of intervention on an individualized basis to make sure that treatments are focused on participants who will respond to them in dosages that they will benefit from. For instance, a therapist could provide speech perception training to accelerate outcomes of production-related treatments. Furthermore, by applying more naturalistic measures of speech perception to this population, especially ones that rely on participants to change over the course of a session, this project provides an innovative opportunity to examine the sensory and perceptual consequences of PD and to link those to better-documented motor outcomes
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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New York
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Buffalo, New York, 미국, 14214
- 모병
- State University of New York at Buffalo
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연락하다:
- Mishaela DiNino, Ph.D.
- 전화번호: 1 (716) 829-5311
- 이메일: dinino@buffalo.edu
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Diagnosis of Parkinson's disease
- Native speaker of North American English
- Use a drug that includes levodopa
- Resident of the United States
Exclusion Criteria:
- Any history of language, hearing or speech disorder outside of Parkinson's disease
- Other gross neurological impairment such as Alzheimer's disease or stroke
- Significant hearing loss and/or use of a hearing aid or cochlear implant
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Learning and Discrimination
Behavioral interventions will be administered, including speech intensity learning, speech intensity discrimination, speech rate learning, and speech rate discrimination |
Participants will be asked to pair sentences that vary in their sound intensity to one of three colored squares (red, yellow, or blue) Participants will hear two sentences that are either the same or different in their sound intensity and will be asked to indicate whether the sentences were of the same or different intensities Participants will be asked to pair sentences that vary in their spoken rate to one of three colored squares (red, yellow, or blue) Participants will hear two sentences that are either the same or different in their spoken rate and will be asked to indicate whether the sentences were of the same or different rates |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean dB SPL
기간: Day 1
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The mean speech intensity (in dB SPL) will be assessed using a recording of spoken sentences and a spoken paragraph. |
Day 1
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Standard deviation dB SPL
기간: Day 1
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The standard deviation of participant's speech intensity (in dB SPL) will be assessed using a recording of spoken sentences and a spoken paragraph. |
Day 1
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Speaking rate
기간: Day 1
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The speaking rate (in syllables/second) will be assessed using a recording of spoken sentences and a spoken paragraph. |
Day 1
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Articulation rate
기간: Day 1
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The articulation rate (in syllables/second after removing pauses) will be assessed using a recording of spoken sentences and a spoken paragraph. |
Day 1
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Unfilled pause time
기간: Day 1
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The unfilled pause time (in seconds of pause) will be assessed using a recording of spoken sentences and a spoken paragraph. |
Day 1
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- STUDY00008661
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Deidentified speech perception and speech production data from individual participants
IPD 공유 기간
Information will be available at the conclusion of data collection and will be available indefinitely
IPD 공유 액세스 기준
Data and supporting material will be available on the Open Science Framework, a database that is open to the general public
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .