Functional Connectivity and Predictors of Affective Aprosodia Intervention in Subacute Right Hemisphere Stroke

Right Hemispheric Stroke Clinical Trial

Official title:

Functional Connectivity and Predictors of Affective Aprosodia Intervention in Subacute Right Hemisphere Stroke

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04575909
• Other study ID #: IRB00264439
• Status: Withdrawn
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: March 19, 2024

Study information

• Verified date: March 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 19, 2024
• Est. primary completion date: March 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• 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

• 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

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Right Hemispheric Stroke
• Speech Disorders
• Stroke

Intervention

Behavioral:
• Aprosodia Intervention
Intervention will focus on improving participants' use and understanding of emotional prosody using implicit and explicit cues, biofeedback, modeling, and feedback.
• No-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.

Locations

Country	Name	City	State
United States	Johns Hopkins School of Medicine	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention
Primary	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.	Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention
Primary	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.	Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention
Primary	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.	1 week after Phase I Intervention, 1 week after Phase II Intervention
Primary	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	Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention
Primary	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.	Baseline, 1 week after Phase I or Phase II Intervention
Secondary	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.	Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention