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

Johns Hopkins University

Status: Enrolling

Conditions: Stroke; Aphasia

Treatments: Behavioral: PICTURE-IT; Behavioral: CoDeLT

Study type: Interventional

Funder types: Other

Identifiers

NCT05845047

IRB00387816

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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70 participants in 2 patient groups

PICTURE IT Intervention-CoDeLT Intervention

Experimental group

Description:

Participants will receive PICTURE IT Intervention for 15 sessions followed by Computer Delivered Lexical Treatment (CoDeLT)Intervention for 15 sessions

Treatment:

Behavioral: CoDeLT

Behavioral: PICTURE-IT

CoDeLT Intervention-PICTURE IT Intervention

Active Comparator group

Description:

Participants will receive Computer Delivered Lexical Treatment (CoDeLT) Intervention for 15 sessions followed by PICTURE IT Intervention for 15 sessions

Treatment:

Behavioral: CoDeLT

Behavioral: PICTURE-IT