An interventional study of Aprosodia Intervention and No-Intervention in Right Hemispheric Stroke, sponsored by Johns Hopkins University. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2024-03-20.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
Among 38 studies in Stroke by Johns Hopkins University — 13 open to participants now, 16 under way, none of them phase 3. Stroke · Johns Hopkins University.
Among the 38 studies in Stroke by Johns Hopkins University, this one is the 31st largest by enrollment of the 33 interventional ones, is one of 9 that started in 2021, is one of 22 with no phase, and was the 23rd registered.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
Browse Stroke studies →13 of the 38 studies in Stroke by Johns Hopkins University are open now, in 1 country. Each count lists the studies.
Of the 1,415 Stroke studies recruiting now, 697 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.
This study: 18 Years to 89 Years · all sexes · no healthy volunteers.
The full table on the hub →38 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 9 started in 2021.
Median enrollment 32 across the 33 interventional studies, 55 across the 5 observational. Of the 18 that completed or were terminated, 11 (61%) have results posted.
Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
10 of the studies in Stroke by Johns Hopkins University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05970406Johns Hopkins UniversityHigh Intensity Dysphagia Rehab for Acute Ischemic Stroke Patients | 2026-11-30 |
| NCT05611918Johns Hopkins UniversityREpeated ASSEssment of SurvivorS in Intracerebral Hemorrhage Study | 2026-12-31 |
| NCT07053917Johns Hopkins UniversityPsychedelic Healing: Adjunct Therapy Harnessing Opened Malleability | 2027-02 |
| NCT03843463Johns Hopkins UniversityEscitalopram and Language Intervention for Subacute Aphasia | 2027-02-18 |
| NCT05556395Johns Hopkins UniversityGlobal Blood-Brain Barrier Disruption and Post-Stroke Cognitive Decline | 2027-04-01 |
Among the 38 studies in Stroke by Johns Hopkins University, from their registry updates:
This study is an investigation of a behavioral speech and language treatment for emotional prosody recognition and production deficits in subacute right hemisphere stroke.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Explicit cues will be provided to help participants improve expression of targeted affective prosody.
Behavioral: Aprosodia Intervention
Implicit cues will be provided to help participants improve expression of targeted affective prosody.
Behavioral: Aprosodia Intervention
Explicit cues will be provided to help participants improve recognition of targeted affective prosody.
Behavioral: Aprosodia Intervention
Implicit cues will be provided to help participants improve recognition of targeted affective prosody.
Behavioral: Aprosodia Intervention
Sessions will comprise conversation about current events, recovery progress (including speech therapy goals targeted in outside intervention \[if relevant\]), hobbies, and other similar topics.
Behavioral: No-Intervention
Intervention will focus on improving participants' use and understanding of emotional prosody using implicit and explicit cues, biofeedback, modeling, and feedback.
Sessions will comprise conversation about current events, recovery progress (including speech therapy goals targeted in outside intervention \[if relevant\]), hobbies, and other similar topics.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Baseline, 1 week after Phase I or Phase II Intervention
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.
Time frame: Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention
Plan to share: No
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This study is withdrawn, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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