AphasiaNCT05248295
Investigating the Effects of Rhythm and Entrainment on Fluency in People With Aphasia
A study testing Unison speech (vs. solo) and Metrical timing (vs. conversational) in people with Aphasia and Apraxia of Speech, run by MGH Institute of Health Professions at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aphasia, Apraxia of Speech
- What is being tested?
- Unison speech (vs. solo) and Metrical timing (vs. conversational)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2018to 28 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Aphasia is an acquired language disorder, most commonly due to stroke. It can affect an individual's ability to speak, understand spoken language, read, and write. Many treatments designed to improve spoken language in persons with aphasia (PWAs) use unison speech, having the person with aphasia speak along with the clinician or with a recording. One goal of this study is to determine who benefits from speaking in unison, and what characteristics of speech help them the most. Another goal is to investigate a possible mechanism for this benefit: why does speaking in unison help? This knowledge is important because understanding who benefits from this commonly used and potentially powerful therapy component, under which conditions they benefit, and why they do, is critical for customizing therapy so it can be as effective and efficient as possible. Unison speech is conducted using one of two different timing patterns: (1) a natural conversational pattern, which is used in everyday conversations, or (2) a metrical pattern, which follows a beat-based timing framework, as in songs or some poems. In either case, precisely aligning one's speech with that of another person (i.e., entraining one's speech) requires prediction: each speaker must plan their own speech motor commands before having heard the other speaker say the words they are planning. Natural conversational timing requires the speaker to make use of knowledge about language, particularly grammar, to align with the other person. In contrast, a metrical pattern allows a speaker to predict speech timing without relying heavily on language-based knowledge. Given that many PWAs have impaired grammar, we hypothesize that most PWAs will benefit more from speaking in unison to sentences with metrical vs. conversational timing patterns. However, there is great variation in linguistic, motor speech, and timing skills across PWAs, so metrical and conversational timing patterns are likely to have different degrees of effectiveness for different individuals. Results from this study will demonstrate how individual characteristics and speech timing affect whether or not a person with aphasia benefits from speaking in unison. Results will also indicate whether a speaker's ability to predict speech timing is necessary for a benefit of unison speech. Prediction ability will be measured by how closely the speaker aligns their speech with a spoken model.
- Conditions
- Aphasia, Apraxia of Speech
- Being tested
- Unison speech (vs. solo), Metrical timing (vs. conversational)
- Medical subject headings
- Aphasia, Apraxias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unison speech (vs. solo)Behavioural
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.
Metrical timing (vs. conversational)Behavioural
This is the secondary contrast in the 2x2 design described above.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Behavioral: Unison speech (vs. solo); Behavioral: Metrical timing (vs. conversational) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day study visit
Secondary outcomes (1)
Mean Syllable Offset From Model
Of the syllables attempted by the participant, the mean offset from the corresponding target syllable in the model is computed for each syllable for each participant using the formula (p - d) - s, where p is the timing of voicing onset in the participant response, d is the timing of voicing onset in the model, and s is the line delay in the audio equipment. Means are computed for each participant and each condition.
Note this measure can only be computed in the Unison conditions (Unison Metrical and Unison Conversational), since the Solo conditions do not have a simultaneous spoken model to which the participant is trying to align their speech.
Measured: 1 day study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start4 Dec 2018
- Primary completion28 Jun 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- MGH Institute of Health Professions
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Lauryn Zipse, Ph.D., CCC-SLP, MGH Institute of Health Professions
- Investigators
- Lauryn Zipse, PhD, Principal investigator, MGH IHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248295
- Sponsor's protocol ID
- 2018P001160
- Other IDs
- R15DC019231
- Status last verified
- May 2025
- First submitted
- 4 Feb 2022
- Last updated
- 18 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Rhythm and Entrainment on Fluency in People With Aphasia
- ClinicalTrials.gov ID
- NCT05248295
- Acronym / sponsor ID
- 2018P001160
- Conditions
- Aphasia, Apraxia of Speech
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- MGH Institute of Health ProfessionsUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 21 Feb 2022 (actual)
- Results
- Posted 18 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aphasia is an acquired language disorder, most commonly due to stroke. It can affect an individual's ability to speak, understand spoken language, read, and write. Many treatments designed to improve spoken language in persons with aphasia (PWAs) use unison speech, having the person with aphasia speak along with the clinician or with a recording. One goal of this study is to determine who benefits from speaking in unison, and what characteristics of speech help them the most. Another goal is to investigate a possible mechanism for this benefit: why does speaking in unison help? This knowledge is important because understanding who benefits from this commonly used and potentially powerful therapy component, under which conditions they benefit, and why they do, is critical for customizing therapy so it can be as effective and efficient as possible. Unison speech is conducted using one of two different timing patterns: (1) a natural conversational pattern, which is used in everyday conversations, or (2) a metrical pattern, which follows a beat-based timing framework, as in songs or some poems. In either case, precisely aligning one's speech with that of another person (i.e., entraining one's speech) requires prediction: each speaker must plan their own speech motor commands before having heard the other speaker say the words they are planning. Natural conversational timing requires the speaker to make use of knowledge about language, particularly grammar, to align with the other person. In contrast, a metrical pattern allows a speaker to predict speech timing without relying heavily on language-based knowledge. Given that many PWAs have impaired grammar, we hypothesize that most PWAs will benefit more from speaking in unison to sentences with metrical vs. conversational timing patterns. However, there is great variation in linguistic, motor speech, and timing skills across PWAs, so metrical and conversational timing patterns are likely to have different degrees of effectiveness for different individuals. Results from this study will demonstrate how individual characteristics and speech timing affect whether or not a person with aphasia benefits from speaking in unison. Results will also indicate whether a speaker's ability to predict speech timing is necessary for a benefit of unison speech. Prediction ability will be measured by how closely the speaker aligns their speech with a spoken model.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with aphasia | Experimental | Behavioral: Unison speech (vs. solo), Behavioral: Metrical timing (vs. conversational)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). |
| Healthy controls | Other | Behavioral: Unison speech (vs. solo), Behavioral: Metrical timing (vs. conversational)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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unison speech (vs. solo)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. | Behavioural | Healthy controls, People with aphasia |
| Metrical timing (vs. conversational)This is the secondary contrast in the 2x2 design described above. | Behavioural | Healthy controls, People with aphasia |
Primary outcome
Percent Syllables Correct
Time frame: 1 day study visit
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 secondary outcome
Mean Syllable Offset From Model
Time frame: 1 day study visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Aphasia
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauryn Zipse, PhD principal investigator
MGH IHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unison speech (vs. solo) and Metrical timing (vs. conversational) in people with Aphasia and Apraxia of Speech, run by MGH Institute of Health Professions at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Syllables Correct (time frame: 1 day study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.