Right Hemispheric StrokeNCT04575909
Functional Connectivity and Predictors of Affective Aprosodia Intervention in Subacute Right Hemisphere Stroke
A study testing Aprosodia Intervention and No-Intervention in people with Right Hemispheric Stroke, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study is an investigation of a behavioral speech and language treatment for emotional prosody recognition and production deficits in subacute right hemisphere stroke. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Right Hemispheric Stroke
- What is being tested?
- Aprosodia Intervention and No-Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 19 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic stroke to the right cerebral hemisphere
- No history of other significant neurological disease or injury affecting the brain (excluding prior lacunar stroke, asymptomatic stroke, or TIA)
- Proficient speaker of English prior to stroke per self-report
- Capable of providing informed consent or indicating another to provide informed consent
- Ages 18-89
- Demonstration of receptive and/or expressive aprosodia on standardized measures of aprosodia
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- Does not have severe cognitive impairment (MoCA > 9)
- Is not severely depressed (PHQ-9 < 20)
- Does not have more than mild motor speech impairment (ASRS < 16 and Dysarthria severity < 3)
- Normal or corrected-to-normal hearing and vision via screening tasks and self-report
- Medically stable
- Not taking any medications that may interfere with prosody processing
- Participation in speech therapy not targeting aprosodia
Who cannot join
- Ischemic stroke outside the right hemisphere or primary hemorrhagic stroke in the right hemisphere
- History of symptomatic stroke or significant neurological disease or injury affecting the brain
- No proficiency in English based on self-report
- Unable to provide informed consent or to indicate another to provide informed consent
- Children < 18 and adults 90+ years
- No demonstration of expressive or receptive aprosodia
Show all 13Show fewer
- Severe cognitive-linguistic impairment (MoCA < 16)
- Severe depression (PHQ-9 > 19)
- More than mild motor speech impairment (ASRS > 15 + Dysarthria severity < 2)
- Uncorrected hearing/vision loss via screening tasks and self-report
- Not medically stable
- Reported medication use that may interfere with prosody processing
- Participating in outside speech therapy targeting aprosodia
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
About this study
This study is an investigation of a behavioral speech and language treatment for emotional prosody recognition and production deficits in subacute right hemisphere stroke.
Read the detailed description
The phrase, "it's not what you say, but how you say it" neatly sums up prosody - the changes to one's tone of voice that transmit meaning. Changes to speech rate, rhythm, volume, and pitch to convey emotion fall into the category of affective, or emotional, prosody. That is, the changes made to the voice to express feelings, such as happy or sad.
Following damage to the right side of the brain, such as in stroke, difficulties in affective prosody understanding and use have been observed. These findings have led researchers to view the right hemisphere as playing a critical role for emotional prosody. Affective prosody difficulties do not always spontaneously improve after acute right hemisphere stroke, and only a few evidenced-based treatments are available for these individuals. It is also understood that affective prosody difficulties can negatively impact social interactions and relationships, including those who care for individuals with emotional prosody difficulties. With miscommunication frequently occurring between those living with affective prosody disorders and those with whom these people interact, the risk of reduced quality of life and social isolation is possible and could be related to poorer health outcomes. Not only might there be personal burdens associated with poor management of communication difficulties in right hemisphere stroke and dementia, but there might also be economic burdens as well. In addition to counseling caregivers, family, and friends about the communication changes of loved ones, more evidenced-based speech and language treatment options are needed for those living with affective prosody disorders.
Cognitive-Linguistic and Speech-Language Assessment: During baseline testing, detailed speech-language and cognitive-communication behavioral testing will occur, focusing on aprosodia, awareness, motor speech, attention, verbal working memory, executive function, discourse, social participation, and emotion. Detailed testing focusing on aprosodia will occur after each Intervention Phase.
Functional near-infrared spectroscopy: Resting state functional connectivity as measured via functional near-infrared spectroscopy (fNIRS) will be assessed at Baseline, Post Phase I, and Post Phase II testing time points to track longitudinal change in functional connectivity patterns associated with targeted aprosodia intervention.
Aprosodia Intervention Phase: The aprosodia intervention will target receptive and expressive prosody over the course of four (4) weeks (12 sessions total). The receptive prosody intervention phase will occur for two weeks (6 sessions total, 3 sessions/week), and the expressive prosody intervention phase will occur for two weeks (6 sessions total, 3 sessions/week). Within each phase, the types of cues participants receive will also vary. Half of the expressive prosody intervention phase will use explicit cues (3 sessions total, 1 week), and the other half of the expressive prosody intervention phase will use implicit cues (3 sessions total, 1 week). This same setup for expressive prosody intervention phase will be used in the receptive prosody intervention phase. In addition to these implicit and explicit cues, expressive prosody intervention will also include feedback to increase awareness.
No-Intervention Phase: Participants will meet study personnel with the same frequency and duration (3 sessions/week, ~1 hour/session) during the No-Intervention Phase as during REACT. Sessions will comprise conversation about current events, recovery progress (including speech therapy goals targeted in outside intervention [if relevant]), hobbies, and other similar topics.
- Conditions
- Right Hemispheric Stroke
- Being tested
- Aprosodia Intervention, No-Intervention
- Keywords
- Prosody, Emotion, Stroke, Speech therapy
- Medical subject headings
- Stroke, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aprosodia InterventionBehavioural
Intervention will focus on improving participants' use and understanding of emotional prosody using implicit and explicit cues, biofeedback, modeling, and feedback.
No-InterventionBehavioural
Sessions will comprise conversation about current events, recovery progress (including speech therapy goals targeted in outside intervention [if relevant]), hobbies, and other similar topics.
| Study group | Role | What they receive |
|---|---|---|
| Explicit Expressive Prosody Intervention | Experimental | Explicit cues will be provided to help participants improve expression of targeted affective prosody. Receives: Behavioral: Aprosodia Intervention |
| Implicit Expressive Prosody Intervention | Experimental | Implicit cues will be provided to help participants improve expression of targeted affective prosody. Receives: Behavioral: Aprosodia Intervention |
| Explicit Receptive Prosody Intervention | Experimental | Explicit cues will be provided to help participants improve recognition of targeted affective prosody. Receives: Behavioral: Aprosodia Intervention |
| Implicit Receptive Prosody Intervention | Experimental | Implicit cues will be provided to help participants improve recognition of targeted affective prosody. Receives: Behavioral: Aprosodia Intervention |
| No-Intervention | Active comparator | Sessions will comprise conversation about current events, recovery progress (including speech therapy goals targeted in outside intervention [if relevant]), hobbies, and other similar topics. Receives: Behavioral: No-Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in accuracy on affective prosody expression following aprosodia intervention compared to spontaneous recovery
Change in accuracy of participants' ability to express affective prosody on sentence lists (list score range 0-45), with increasing accuracy indicating better outcome.
Measured: Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention
Change in accuracy on affective prosody recognition following aprosodia intervention compared to spontaneous recovery
Change in accuracy of participants' ability to express affective prosody on sentence lists (list score range 0-45), with increasing accuracy indicating better outcome.
Measured: Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention
Change in accuracy on standardized contextual measures of affective prosody expression
Change in accuracy on the Montreal Evaluation of Communication (score range 0-18), with increasing score indicating better outcome.
Measured: Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention
Change in accuracy on standardized contextualized measures of affective prosody recognition
Change in accuracy on The Awareness of Social Inference Test (score range 0-24, with increasing score indicating better outcome.
Measured: 1 week after Phase I Intervention, 1 week after Phase II Intervention
Change in resting state functional connectivity
Differences in resting state functional connectivity patterns within prosody-specific regions of interest and left homologues (connectivity association range 0-0.99), with increasing association values indicating stronger connectivity
Measured: Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention
Behavioral and neurological predictors of aprosodia intervention outcomes
Scores on baseline cognitive-linguistic assessments and percent damage to lesioned regions of interest, larger beta coefficients indicating a stronger relationship between predictor (baseline behavioral and neurological data) and predicted (prosody accuracy) variables.
Measured: Baseline, 1 week after Phase I or Phase II Intervention
Secondary outcomes (1)
Change in standardized acoustic features (rate, frequency, intensity, rhythm), on standardized measures of prosody expression
Change in z-scored acoustic features on the Montreal Evaluation of Communication expression subtest, with scores closer to zero indicating better outcome.
Measured: Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Feb 2021
- Primary completion19 Mar 2024
- Study completion19 Mar 2024
Why it stopped: Funding not received
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right Hemispheric StrokeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A crossover trial design with randomized order of intervention (REACT/no-intervention, no-intervention/REACT). Half of participants will be randomly assigned to REACT in Phase I, and the other half will be randomly assigned to start with no-intervention in Phase I. In Phase II, participants will receive the alternative intervention not received during Phase I.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Argye E Hillis, MD, MA, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575909
- Sponsor's protocol ID
- IRB00264439
- Status last verified
- Mar 2024
- First submitted
- 18 Sep 2020
- Last updated
- 20 Mar 2024
- Results posted
- No
- 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 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Connectivity and Predictors of Affective Aprosodia Intervention in Subacute Right Hemisphere Stroke
- ClinicalTrials.gov ID
- NCT04575909
- Acronym / sponsor ID
- IRB00264439
- Conditions
- Right Hemispheric Stroke
- Keywords
- Prosody, Emotion, Stroke, Speech therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding not received
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 19 Mar 2024 (actual)
- Study completion
- 19 Mar 2024 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an investigation of a behavioral speech and language treatment for emotional prosody recognition and production deficits in subacute right hemisphere stroke.
Detailed description
The phrase, "it's not what you say, but how you say it" neatly sums up prosody - the changes to one's tone of voice that transmit meaning. Changes to speech rate, rhythm, volume, and pitch to convey emotion fall into the category of affective, or emotional, prosody. That is, the changes made to the voice to express feelings, such as happy or sad.
Following damage to the right side of the brain, such as in stroke, difficulties in affective prosody understanding and use have been observed. These findings have led researchers to view the right hemisphere as playing a critical role for emotional prosody. Affective prosody difficulties do not always spontaneously improve after acute right hemisphere stroke, and only a few evidenced-based treatments are available for these individuals. It is also understood that affective prosody difficulties can negatively impact social interactions and relationships, including those who care for individuals with emotional prosody difficulties. With miscommunication frequently occurring between those living with affective prosody disorders and those with whom these people interact, the risk of reduced quality of life and social isolation is possible and could be related to poorer health outcomes. Not only might there be personal burdens associated with poor management of communication difficulties in right hemisphere stroke and dementia, but there might also be economic burdens as well. In addition to counseling caregivers, family, and friends about the communication changes of loved ones, more evidenced-based speech and language treatment options are needed for those living with affective prosody disorders.
Cognitive-Linguistic and Speech-Language Assessment: During baseline testing, detailed speech-language and cognitive-communication behavioral testing will occur, focusing on aprosodia, awareness, motor speech, attention, verbal working memory, executive function, discourse, social participation, and emotion. Detailed testing focusing on aprosodia will occur after each Intervention Phase.
Functional near-infrared spectroscopy: Resting state functional connectivity as measured via functional near-infrared spectroscopy (fNIRS) will be assessed at Baseline, Post Phase I, and Post Phase II testing time points to track longitudinal change in functional connectivity patterns associated with targeted aprosodia intervention.
Aprosodia Intervention Phase: The aprosodia intervention will target receptive and expressive prosody over the course of four (4) weeks (12 sessions total). The receptive prosody intervention phase will occur for two weeks (6 sessions total, 3 sessions/week), and the expressive prosody intervention phase will occur for two weeks (6 sessions total, 3 sessions/week). Within each phase, the types of cues participants receive will also vary. Half of the expressive prosody intervention phase will use explicit cues (3 sessions total, 1 week), and the other half of the expressive prosody intervention phase will use implicit cues (3 sessions total, 1 week). This same setup for expressive prosody intervention phase will be used in the receptive prosody intervention phase. In addition to these implicit and explicit cues, expressive prosody intervention will also include feedback to increase awareness.
No-Intervention Phase: Participants will meet study personnel with the same frequency and duration (3 sessions/week, ~1 hour/session) during the No-Intervention Phase as during REACT. Sessions will comprise conversation about current events, recovery progress (including speech therapy goals targeted in outside intervention [if relevant]), hobbies, and other similar topics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- Model description
- A crossover trial design with randomized order of intervention (REACT/no-intervention, no-intervention/REACT). Half of participants will be randomly assigned to REACT in Phase I, and the other half will be randomly assigned to start with no-intervention in Phase I. In Phase II, participants will receive the alternative intervention not received during Phase I.
| Arm | Type | Receives |
|---|---|---|
| Explicit Expressive Prosody Intervention | Experimental | Behavioral: Aprosodia InterventionExplicit cues will be provided to help participants improve expression of targeted affective prosody. |
| Implicit Expressive Prosody Intervention | Experimental | Behavioral: Aprosodia InterventionImplicit cues will be provided to help participants improve expression of targeted affective prosody. |
| Explicit Receptive Prosody Intervention | Experimental | Behavioral: Aprosodia InterventionExplicit cues will be provided to help participants improve recognition of targeted affective prosody. |
| Implicit Receptive Prosody Intervention | Experimental | Behavioral: Aprosodia InterventionImplicit cues will be provided to help participants improve recognition of targeted affective prosody. |
| No-Intervention | Active comparator | Behavioral: No-InterventionSessions will comprise conversation about current events, recovery progress (including speech therapy goals targeted in outside intervention [if relevant]), hobbies, and other similar topics. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Ischemic stroke to the right cerebral hemisphere
- No history of other significant neurological disease or injury affecting the brain (excluding prior lacunar stroke, asymptomatic stroke, or TIA)
- Proficient speaker of English prior to stroke per self-report
- Capable of providing informed consent or indicating another to provide informed consent
- Ages 18-89
Key exclusion criteria (13 listed)
- Ischemic stroke outside the right hemisphere or primary hemorrhagic stroke in the right hemisphere
- History of symptomatic stroke or significant neurological disease or injury affecting the brain
- No proficiency in English based on self-report
- Unable to provide informed consent or to indicate another to provide informed consent
- Children < 18 and adults 90+ years
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 |
|---|---|---|
| Aprosodia InterventionIntervention will focus on improving participants' use and understanding of emotional prosody using implicit and explicit cues, biofeedback, modeling, and feedback. | Behavioural | Explicit Expressive Prosody Intervention, Explicit Receptive Prosody Intervention, Implicit Expressive Prosody Intervention, Implicit Receptive Prosody Intervention |
| No-InterventionSessions will comprise conversation about current events, recovery progress (including speech therapy goals targeted in outside intervention [if relevant]), hobbies, and other similar topics. | Behavioural | No-Intervention |
Primary outcome
Change in accuracy on affective prosody expression following aprosodia intervention compared to spontaneous recovery
Time frame: Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention
Change in accuracy of participants' ability to express affective prosody on sentence lists (list score range 0-45), with increasing accuracy indicating better outcome.
Change in accuracy on affective prosody recognition following aprosodia intervention compared to spontaneous recovery
Time frame: Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention
Change in accuracy of participants' ability to express affective prosody on sentence lists (list score range 0-45), with increasing accuracy indicating better outcome.
Change in accuracy on standardized contextual measures of affective prosody expression
Time frame: Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention
Change in accuracy on the Montreal Evaluation of Communication (score range 0-18), with increasing score indicating better outcome.
Change in accuracy on standardized contextualized measures of affective prosody recognition
Time frame: 1 week after Phase I Intervention, 1 week after Phase II Intervention
Change in accuracy on The Awareness of Social Inference Test (score range 0-24, with increasing score indicating better outcome.
Change in resting state functional connectivity
Time frame: Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention
Differences in resting state functional connectivity patterns within prosody-specific regions of interest and left homologues (connectivity association range 0-0.99), with increasing association values indicating stronger connectivity
Behavioral and neurological predictors of aprosodia intervention outcomes
Time frame: Baseline, 1 week after Phase I or Phase II Intervention
Scores on baseline cognitive-linguistic assessments and percent damage to lesioned regions of interest, larger beta coefficients indicating a stronger relationship between predictor (baseline behavioral and neurological data) and predicted (prosody accuracy) variables.
1 secondary outcome
Change in standardized acoustic features (rate, frequency, intensity, rhythm), on standardized measures of prosody expression
Time frame: Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No
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.
Argye E Hillis, MD, MA principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aprosodia Intervention and No-Intervention in people with Right Hemispheric Stroke, run by Johns Hopkins University 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 13 inclusion and 13 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: withdrawn, as of the sponsor's last update on 20 Mar 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in accuracy on affective prosody expression following aprosodia intervention compared to spontaneous recovery (time frame: Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention). The study lists 6 primary outcomes in all. 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 20 Mar 2024.