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Producing Increasingly Complex Themes Using Right-hemisphere Engagement (PICTURE) Implemented With Telemedicine

Not Applicable
Recruiting
Conditions
Stroke
Aphasia
Interventions
Behavioral: PICTURE-IT
Behavioral: CoDeLT
Registration Number
NCT05845047
Lead Sponsor
Johns Hopkins University
Brief Summary

The investigators propose a pilot crossover trial of 2 behavioral language treatments, with randomized order of treatments and blinded assessors, to determine if a therapy designed to stimulate right hemisphere functions (Producing Increasingly Complex Themes Using Right-hemisphere Engagement Implemented with Telemedicine - PICTURE IT; described below) is more effective in improving discourse than a published computer delivered lexical treatment (shown previously to improve naming) in subacute post-stroke aphasia.

Detailed Description

The investigators will carry out a crossover study with randomized order of treatment conditions and blinded assessors, to compare changes in content and efficiency of discourse (primary outcome measures) from before treatment to immediately after treatment, to compare intervention focused on engaging the right hemisphere (PICTURE IT; see below) to a purely lexical treatment (see details below). Secondary outcome measures will be: (1) changes in discourse from pre-treatment to 2 weeks post-treatment, and (2) changes in naming of objects and actions from immediately before treatment to immediately after treatment, and (3) changes in naming of objects and actions from pre-treatment to 2 months after both treatments. The investigators will also carry out resting state functional near infrared spectroscopy (fNIRS) before and after each treatment to evaluate degree and location (e.g. intrahemispheric right versus left) of changes in connectivity associated with each treatment and with changes in each outcome measure. The investigators will also take saliva samples from participants who agree to this optional part of the study to determine the participants brain-derived neurotrophic factor status.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
70
Inclusion Criteria
  1. Diagnosis of aphasia secondary to stroke and presence of naming deficits (at least 20% errors on the Boston Naming Test or Hopkins Action Naming Assessment)
  2. Capable of giving informed consent or indicating another to provide informed consent
  3. Age 18 or older
  4. The stroke must have occurred between 1 month and 4 months prior to enrollment in the study or more than 6 months prior to enrollment in the study
  5. Able to understand therapy tasks (as indicated by 5 probes of each)
Exclusion Criteria
  1. Lack of English proficiency (by self/legally authorized representative report)
  2. Prior history of neurologic disease affecting the brain (e.g., brain tumor, multiple sclerosis, traumatic brain injury) other than stroke
  3. Prior history of severe psychiatric illness, developmental disorders or intellectual disability (e.g., PTSD, schizophrenia, obsessive-compulsive disorder, autism spectrum disorders)
  4. Uncorrected severe visual loss or hearing loss by self-report and medical records

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
PICTURE IT Intervention-CoDeLT InterventionPICTURE-ITParticipants will receive PICTURE IT Intervention for 15 sessions followed by Computer Delivered Lexical Treatment (CoDeLT)Intervention for 15 sessions
CoDeLT Intervention-PICTURE IT InterventionPICTURE-ITParticipants will receive Computer Delivered Lexical Treatment (CoDeLT) Intervention for 15 sessions followed by PICTURE IT Intervention for 15 sessions
CoDeLT Intervention-PICTURE IT InterventionCoDeLTParticipants will receive Computer Delivered Lexical Treatment (CoDeLT) Intervention for 15 sessions followed by PICTURE IT Intervention for 15 sessions
PICTURE IT Intervention-CoDeLT InterventionCoDeLTParticipants will receive PICTURE IT Intervention for 15 sessions followed by Computer Delivered Lexical Treatment (CoDeLT)Intervention for 15 sessions
Primary Outcome Measures
NameTimeMethod
Change in discourse content as assessed by z-score for the number of meaning-carrying units used in describing a pictureBaseline, 1 week after treatment

Change in z-score for the number of meaning-carrying units used in describing a picture. There is no maximum number of meaning-carrying units, but norms are available to assist in the interpretation of this performance.

Secondary Outcome Measures
NameTimeMethod
Change in discourse informational efficiency as assessed by z-score for the number of syllables of meaning-carrying units used in describing a pictureBaseline, 1 week after treatment

Change in z-score for the number of syllables/number of meaning-carrying units used in describing a picture. There is no maximum number of meaning-carrying units, but norms are available to assist in the interpretation of this performance.

Change in resting state functional connectivity as assessed by near-infrared spectroscopyBaseline, 1 week after treatment

Measure of correlation between activation of brain regions at rest using functional near-infrared spectroscopy. Right hemisphere intrahemispheric, left hemisphere intrahemispheric, and interhemispheric measures will be examined.

Change in accuracy of naming actions as assessed by the Hopkins Action Naming Assessment formBaseline, 1 week after treatment

Change in accuracy of naming actions on the 30-item Hopkins Action Naming Assessment. Scores range from 0 to 30 with higher scores meaning better naming ability.

Change in accuracy of naming objects as assessed by the Boston Naming TestBaseline, 1 week after treatment

Change in accuracy of naming objects on the 30-item Boston Naming Test. Scores range from 0 to 30 with higher scores meaning better naming ability.

Trial Locations

Locations (1)

Johns Hopkins School of Medicine

🇺🇸

Baltimore, Maryland, United States

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