NCT05248295

Brief Summary

Speaking in unison with another person is included as a part of many treatment approaches for aphasia. It is not well understood why and how this technique works. One goal of this study is to determine who benefits from speaking in unison, and what characteristics of speech are most helpful. Another goal is to investigate a possible mechanism for this benefit: why does speaking in unison help? A possible mechanism for this benefit is examined, by testing whether the degree of alignment of a person's speech with that of another speaker can account for unison benefit.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 4, 2018

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2023

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

May 18, 2025

Completed
Last Updated

May 18, 2025

Status Verified

May 1, 2025

Enrollment Period

4.6 years

First QC Date

February 4, 2022

Results QC Date

October 15, 2024

Last Update Submit

May 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percent Syllables Correct

    The percentage of syllables correctly repeated from the target sentences will be computed for each contrast, Unison vs. Solo and Metrical vs. Conversational, capturing all 4 conditions in the 2x2 design (Unison Metrical, Unison Conversational, Solo Metrical, Solo Conversational). A protocol will be used to score syllables for correctness.

    1 day study visit

Secondary Outcomes (1)

  • Mean Syllable Offset From Model

    1 day study visit

Study Arms (2)

People with aphasia

EXPERIMENTAL

Adults with stroke-based aphasia. Designating this group as experimental reflects the focus on studying responses in people with aphasia. All participants will complete the same 4 study conditions in a 2x2 design (Unison vs. Solo and Metrical vs. Conversational).

Behavioral: Unison speech (vs. solo)Behavioral: Metrical timing (vs. conversational)

Healthy controls

OTHER

Adults without a history of speech, language, or neurological disorder, or stroke. This group is intended to serve as a context-providing reference group rather than a true comparator. All participants will complete the same 4 study conditions in a 2x2 design (Unison vs. Solo and Metrical vs. Conversational).

Behavioral: Unison speech (vs. solo)Behavioral: Metrical timing (vs. conversational)

Interventions

Participants will repeat sentences in four conditions, in a 2x2 design with the factors unison vs. solo repetition, and metrical vs. conversational speech timing. Measures of speech accuracy and timing will be collected.

Healthy controlsPeople with aphasia

This is the secondary contrast in the 2x2 design described above.

Healthy controlsPeople with aphasia

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Native-speaker fluency in American English (prior to stroke for people with aphasia)
  • Controls must report no history of speech, language, neurological disorders, or stroke
  • People with aphasia must be at least 6-months post-stroke, and aphasia must be due to stroke

You may not qualify if:

  • Inadequate hearing ability to reliably complete task: fail hearing screen
  • Inadequate cognitive ability to understand and remember task: fail cognition screening (different measures for controls and people with aphasia)
  • Inadequate speech repetition ability to complete task, or to be considered a control: fail speech repetition screening (different thresholds for controls and people with aphasia)
  • Inadequate auditory comprehension ability to understand task: fail auditory comprehension screen (people with aphasia only)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MGH IHP

Boston, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

AphasiaApraxias

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPsychomotor Disorders

Results Point of Contact

Title
Lauryn Zipse
Organization
MGH IHP

Study Officials

  • Lauryn Zipse, PhD

    MGH IHP

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 4, 2022

First Posted

February 21, 2022

Study Start

December 4, 2018

Primary Completion

June 28, 2023

Study Completion

June 28, 2023

Last Updated

May 18, 2025

Results First Posted

May 18, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations