Emotional Prosody Treatment and Functional Connectivity Changes in Subacute Right Hemisphere Stroke

Sponsor
Johns Hopkins University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04575909
Collaborator
(none)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Aprosodia Intervention
N/A

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, anosognosia, motor speech, attention, verbal working memory, executive functioning, discourse, social participation, and emotion. Detailed testing focusing on aprosodia and social participation will occur after each Intervention Phase and at Follow-up testing time points.

Functional near-infrared spectroscopy: Functional connectivity as measured via functional near-infrared spectroscopy (fNIRS) will be assessed at Baseline, Post Phase I, Post Phase II, and Follow-up testing time points to track longitudinal change in functional connectivity patterns associated with targeted aprosodia intervention. fNIRS tasks will comprise resting state and active (receptive prosody reception) tasks.

Aprosodia Intervention: 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 biofeedback.

Study Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Participants will be randomly assigned to expressive-receptive treatment or receptive-expressive treatment order and whether they receive implicit or explicit cues first.Participants will be randomly assigned to expressive-receptive treatment or receptive-expressive treatment order and whether they receive implicit or explicit cues first.
Masking:
Single (Investigator)
Masking Description:
Key personnel will be blinded to participant testing timepoint by having separate personnel administer treatment and assessments for each participant.
Primary Purpose:
Treatment
Official Title:
Emotional Prosody Treatment and Functional Connectivity Changes in Subacute Right Hemisphere Stroke
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Explicit Expressive Prosody Intervention

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

Behavioral: Aprosodia Intervention
Intervention will focus on improving participants' use and understanding of emotional prosody using implicit and explicit cues, biofeedback, modeling, and feedback.

Experimental: Implicit Expressive Prosody Intervention

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

Behavioral: Aprosodia Intervention
Intervention will focus on improving participants' use and understanding of emotional prosody using implicit and explicit cues, biofeedback, modeling, and feedback.

Experimental: Explicit Receptive Prosody Intervention

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

Behavioral: Aprosodia Intervention
Intervention will focus on improving participants' use and understanding of emotional prosody using implicit and explicit cues, biofeedback, modeling, and feedback.

Experimental: Implicit Receptive Prosody Intervention

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

Behavioral: Aprosodia Intervention
Intervention will focus on improving participants' use and understanding of emotional prosody using implicit and explicit cues, biofeedback, modeling, and feedback.

Outcome Measures

Primary Outcome Measures

  1. Change in accuracy on affective prosody expression following direct versus indirect aprosodia intervention [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.

  2. Change in accuracy on affective prosody recognition following direct versus indirect aprosodia intervention [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.

  3. Change in functional connectivity between affective and non-affective tasks before aprosodia intervention [Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention]

    Differences in functional connectivity patterns between affective and non-affective tasks within prosody-specific regions of interest and left homologues (connectivity association range 0-0.99), with increasing association values indicating stronger connectivity

  4. Change in functional connectivity between affective and non-affective tasks after aprosodia intervention [1 week after Phase I Intervention, 1 week after Phase II Intervention, 4 weeks after Phase II Intervention]

    Differences in functional connectivity patterns between affective and non-affective tasks within prosody-specific regions of interest and left homologues (connectivity association range 0-0.99), with increasing association values indicating stronger connectivity

Other Outcome Measures

  1. Change in accuracy on standardized measures of affective prosody expression [Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention, 4 weeks after Phase II Intervention]

    Change in accuracy on the Montreal Evaluation of Communication (score range 0-18), with increasing score indicating better outcome.

  2. Change in accuracy on standardized measures of affective prosody recognition [Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention, 4 weeks after Phase II Intervention]

    Change in accuracy on the Montreal Evaluation of Communication (score range 0-12) and The Awareness of Social Inference Test (score range 0-24, with increasing score indicating better outcome.

  3. Change in accuracy on affective prosody expression [Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention, 4 weeks 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.

  4. Change in accuracy on affective prosody recognition [Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention, 4 weeks after Phase II Intervention]

    Change in accuracy of participants' ability to recognize affective prosody on sentence lists (list score range 0-45), with increasing accuracy indicating better outcome.

  5. Change in report of social participation [Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention, 4 weeks after Phase II Intervention]

    Change in social participation as measure on the Sydney Psychosocial Reintegration Scale Version 2 (score range 0-48), with increasing score indicating worse outcome.

  6. Change in resting state functional connectivity [Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention, 4 weeks 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

  7. Change in standardized acoustic features (rate, frequency, intensity, rhythm), on standardized measures of prosody expression [Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention, 4 weeks after Phase II Intervention]

    Change in z-scored acoustic features on the MEC-expression subtest, with scores closer to zero indicating better outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 89 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins School of Medicine Baltimore Maryland United States 21287

Sponsors and Collaborators

  • Johns Hopkins University

Investigators

  • Principal Investigator: Argye E Hillis, MD, MA, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT04575909
Other Study ID Numbers:
  • IRB00264439
First Posted:
Oct 5, 2020
Last Update Posted:
Jun 14, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Johns Hopkins University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 14, 2022