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

Primary Purpose

Right Hemispheric Stroke

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aprosodia Intervention
No-Intervention
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Right Hemispheric Stroke focused on measuring Prosody, Emotion, Stroke, Speech therapy

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Explicit Expressive Prosody Intervention

Implicit Expressive Prosody Intervention

Explicit Receptive Prosody Intervention

Implicit Receptive Prosody Intervention

No-Intervention

Arm Description

Explicit cues will be provided to help participants improve expression of targeted affective prosody.

Implicit cues will be provided to help participants improve expression of targeted affective prosody.

Explicit cues will be provided to help participants improve recognition of targeted affective prosody.

Implicit cues will be provided to help participants improve recognition of targeted affective prosody.

Sessions will comprise conversation about current events, recovery progress (including speech therapy goals targeted in outside intervention [if relevant]), hobbies, and other similar topics.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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
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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 18, 2020
Last Updated
March 6, 2023
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT04575909
Brief Title
Functional Connectivity and Predictors of Affective Aprosodia Intervention in Subacute Right Hemisphere Stroke
Official Title
Functional Connectivity and Predictors of Affective Aprosodia Intervention in Subacute Right Hemisphere Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Right Hemispheric Stroke
Keywords
Prosody, Emotion, Stroke, Speech therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Outcomes Assessor
Masking Description
Key personnel will be blinded to participant testing timepoint by having separate personnel administer treatment and assessments for each participant.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Explicit Expressive Prosody Intervention
Arm Type
Experimental
Arm Description
Explicit cues will be provided to help participants improve expression of targeted affective prosody.
Arm Title
Implicit Expressive Prosody Intervention
Arm Type
Experimental
Arm Description
Implicit cues will be provided to help participants improve expression of targeted affective prosody.
Arm Title
Explicit Receptive Prosody Intervention
Arm Type
Experimental
Arm Description
Explicit cues will be provided to help participants improve recognition of targeted affective prosody.
Arm Title
Implicit Receptive Prosody Intervention
Arm Type
Experimental
Arm Description
Implicit cues will be provided to help participants improve recognition of targeted affective prosody.
Arm Title
No-Intervention
Arm Type
Active Comparator
Arm Description
Sessions will comprise conversation about current events, recovery progress (including speech therapy goals targeted in outside intervention [if relevant]), hobbies, and other similar topics.
Intervention Type
Behavioral
Intervention Name(s)
Aprosodia Intervention
Intervention Description
Intervention will focus on improving participants' use and understanding of emotional prosody using implicit and explicit cues, biofeedback, modeling, and feedback.
Intervention Type
Behavioral
Intervention Name(s)
No-Intervention
Intervention Description
Sessions will comprise conversation about current events, recovery progress (including speech therapy goals targeted in outside intervention [if relevant]), hobbies, and other similar topics.
Primary Outcome Measure Information:
Title
Change in accuracy on affective prosody expression following aprosodia intervention compared to spontaneous recovery
Description
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
Title
Change in accuracy on affective prosody recognition following aprosodia intervention compared to spontaneous recovery
Description
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
Title
Change in accuracy on standardized contextual measures of affective prosody expression
Description
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
Title
Change in accuracy on standardized contextualized measures of affective prosody recognition
Description
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
Title
Change in resting state functional connectivity
Description
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
Title
Behavioral and neurological predictors of aprosodia intervention outcomes
Description
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
Secondary Outcome Measure Information:
Title
Change in standardized acoustic features (rate, frequency, intensity, rhythm), on standardized measures of prosody expression
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Argye E Hillis, MD, MA
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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