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

NCT04575909 | Withdrawn

• 1 other identifier: IRB00264439
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Right Hemispheric Stroke

Keywords

Prosody; Emotion; Stroke; Speech therapy

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• 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

Study Arms (5)

Explicit Expressive Prosody Intervention

EXPERIMENTAL

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

Behavioral: Aprosodia Intervention

Implicit Expressive Prosody Intervention

EXPERIMENTAL

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

Behavioral: Aprosodia Intervention

Explicit Receptive Prosody Intervention

EXPERIMENTAL

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

Behavioral: Aprosodia Intervention

Implicit Receptive Prosody Intervention

EXPERIMENTAL

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

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.

Behavioral: No-Intervention

Interventions

Aprosodia Intervention BEHAVIORAL

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

Explicit Expressive Prosody Intervention; Explicit Receptive Prosody Intervention; Implicit Expressive Prosody Intervention; Implicit Receptive Prosody Intervention

No-Intervention BEHAVIORAL

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

No-Intervention

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Stroke; Communication Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Argye E Hillis, MD, MA

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Key personnel will be blinded to participant testing timepoint by having separate personnel administer treatment and assessments for each participant.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: October 5, 2020
• Study Start: February 1, 2021
• Primary Completion: March 19, 2024
• Study Completion: March 19, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)