Telemedicine Interventions for Aphasia

(PICTURE IT Trial)

Overseen By Argye E Hillis, MD, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Neurologic disease, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 30 sessions

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two language therapies delivered through telemedicine to assist people with aphasia, a language disorder often caused by strokes. The study compares a new therapy called PICTURE IT, which engages the right side of the brain, with an existing computer-based language treatment known as CoDeLT (Computer Delivered Lexical Treatment) to improve word-finding skills. Participants will receive both treatments in different sequences to determine which is more effective for enhancing communication. Ideal candidates are stroke survivors diagnosed with aphasia who struggle to communicate in daily life. As an unphased trial, this study provides a unique opportunity to explore innovative therapies that could significantly improve communication skills.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both CoDeLT and PICTURE-IT treatments may help people with aphasia, a language disorder often caused by a stroke, improve their language skills. Studies on computer-based language therapies like CoDeLT indicate that these treatments are generally well-tolerated, with most people not experiencing serious side effects.

For PICTURE-IT, which uses the right side of the brain to aid recovery, evidence is more limited. However, similar therapies are usually considered safe and aim to stimulate brain functions that might help improve language skills.

While past studies suggest these therapies are safe, individual experiences can vary. Those considering joining a clinical trial should consult a healthcare provider for more personalized information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these telemedicine interventions for aphasia because they offer a unique, accessible approach to treatment. Unlike traditional in-person speech therapy, CoDeLT and PICTURE-IT leverage technology to deliver therapy remotely, making it more convenient for patients who may face mobility or transportation challenges. Additionally, the Computer Delivered Lexical Treatment (CoDeLT) focuses on enhancing language processing through structured computer programs, while PICTURE-IT uses visual imagery to reinforce language comprehension. These innovative methods provide flexibility and adaptability, potentially reaching a broader range of patients and offering personalized therapy options that can be tailored to individual needs.

What evidence suggests that this trial's treatments could be effective for aphasia?

Research shows that the Computer Delivered Lexical Treatment (CoDeLT), one of the interventions in this trial, can help adults with aphasia improve their language skills. Studies have found that this computer-based therapy leads to significant improvements in communication, similar to traditional sessions with a therapist. CoDeLT also reduces communication problems in people with long-term aphasia.

For the PICTURE IT treatment, another intervention in this trial, early results suggest it might improve speech by engaging the right side of the brain. This method focuses on creating more complex speech patterns, aiding in naming objects and actions. While both treatments use different approaches, each shows promise in enhancing language skills for those with aphasia after a stroke. Participants in this trial will receive both interventions in different sequences to evaluate their effectiveness. ^{1 2 6 7 8}

Who Is on the Research Team?

Argye E Hillis, MD, MA

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had a stroke between 1 to 4 months ago, leading to aphasia with difficulty in naming objects. Participants must be able to give consent and understand therapy tasks. It's not for those with severe vision/hearing loss, non-English speakers, or individuals with other brain-affecting diseases or severe psychiatric conditions.

Inclusion Criteria

I have trouble finding words due to a stroke.

I can give my own consent or appoint someone to do it for me.

My stroke happened 1-4 months ago or more than 6 months ago.

Exclusion Criteria

Prior history of severe psychiatric illness, developmental disorders or intellectual disability (e.g., PTSD, schizophrenia, obsessive-compulsive disorder, autism spectrum disorders)

Lack of English proficiency (by self/legally authorized representative report)

Uncorrected severe visual loss or hearing loss by self-report and medical records

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Computer Delivered Lexical Treatment (CoDeLT) Intervention for 15 sessions followed by PICTURE IT Intervention for 15 sessions, or vice versa

30 sessions

Follow-up

Participants are monitored for changes in discourse and naming abilities post-treatment

2 months

What Are the Treatments Tested in This Trial?

Interventions

• CoDeLT
• PICTURE-IT

Trial Overview The PICTURE IT study tests two language therapies using telemedicine for post-stroke aphasia: one stimulates the right side of the brain (PICTURE IT) and another computer-based treatment improves naming (CoDeLT). The effectiveness of each will be compared in a randomized order with blinded assessors.

How Is the Trial Designed?

Group I: PICTURE IT Intervention-CoDeLT Intervention Experimental Treatment 2 Interventions

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

Group II: CoDeLT Intervention-PICTURE IT Intervention Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

In a pilot study involving 62 participants with post-stroke aphasia, speech-language telerehabilitation delivered via videoconference showed significant improvements in repetition and sentence production scores compared to usual care alone, indicating potential efficacy in language rehabilitation.

No adverse events were reported during the study, suggesting that telerehabilitation is a safe intervention; however, a larger definitive trial with 230 participants is necessary to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of augmented speech-language therapy delivered by telerehabilitation on poststroke aphasia-a pilot randomized controlled trial. Øra, HP., Kirmess, M., Brady, MC., et al.[2022]

The study demonstrated that standardized assessments for aphasia can be effectively conducted online via videoconferencing, showing no significant differences in scores compared to face-to-face assessments among 32 participants with aphasia.

Participants reported high satisfaction with the online assessment experience, indicating that telerehabilitation could be a viable and effective alternative for ongoing treatment of aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing acquired language disorders in adults via the Internet. Theodoros, D., Hill, A., Russell, T., et al.[2022]

In a case series study involving seven participants with long-standing aphasia due to a cerebrovascular accident, all individuals showed improvement in word finding after receiving home-based language therapy monitored via the Internet.

Additionally, four out of the seven participants experienced enhancements in their overall communication skills, suggesting that this therapy approach can be effective for individuals with aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of computerised rehabilitation for long-term aphasia: a case series study. Mortley, J., Wade, J., Enderby, P., et al.[2018]

A home-based, computer-delivered intervention significantly reduced communication difficulties in 20 adults with chronic aphasia, showing a decrease of 6.79 points on the Communication Difficulty subscale of the Burden of Stroke Scale during the intervention (P=.038).

The improvements in communication were maintained during the follow-up period, suggesting that this intervention could be a promising approach for enhancing conversational skills in individuals with aphasia, although further research is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported changes in communication after computer-based script training for aphasia. Manheim, LM., Halper, AS., Cherney, L.[2022]

Telerehabilitation (telerehab) for treating reading deficits in patients with phonological alexia was successfully implemented, showing significant improvements in reading similar to traditional in-person methods.

Participants reported high satisfaction with the telerehab approach, indicating that it is not only feasible but may also be as effective as face-to-face treatment while saving resources for both patients and clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful remote delivery of a treatment for phonological alexia via telerehab. Getz, H., Snider, S., Brennan, D., et al.[2018]

In a 12-week study involving nine individuals with chronic aphasia, participants showed significant improvements in communication skills, with the Communicative Effectiveness Index increasing by an average of 17.8 points (p = .01) and the Communication Confidence Rating Scale improving by 10.4 points (p = .0004).

Participants also reported high satisfaction with the teletherapy services, and their independent practice of online language exercises increased over the course of the study, indicating that the combined approach of therapy and self-practice was effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining Teletherapy and On-line Language Exercises in the Treatment of Chronic Aphasia: An Outcome Study. Steele, RD., Baird, A., McCall, D., et al.[2020]

The Web ORLA® treatment significantly improved language performance in adults with chronic aphasia, showing notable gains both immediately after treatment and six weeks later, with effect sizes indicating meaningful improvements.

While the initial gains from treatment were similar to the control group, the Web ORLA® group demonstrated significantly greater language improvements at the six-week follow-up, highlighting the long-term benefits of this intensive, remote therapy combined with clinician oversight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based Oral Reading for Language in Aphasia (Web ORLA®): A pilot randomized control trial. Cherney, LR., Lee, JB., Kim, KA., et al.[2022]

In a study involving 23 chronic aphasic patients, the use of a computer-based treatment system led to significant improvements in language function, as measured by standardized assessment tools like the Porch Index of Communicative Ability and the Boston Naming Test.

The therapy sessions, conducted by speech-language pathologists, demonstrated that innovative technology can effectively enhance communication abilities in patients who had previously received traditional therapy, indicating a promising approach for long-term rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting recovery in chronic aphasia with an interactive technology. Aftonomos, LB., Steele, RD., Wertz, RT.[2019]

A feasibility study involving 21 participants with aphasia showed that word finding therapy delivered remotely via video conferencing significantly improved picture naming abilities compared to an attention control group.

The study demonstrated high treatment fidelity and participant satisfaction, indicating that both remote and face-to-face therapy methods are effective for delivering this type of intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of remote therapy, face to face therapy and an attention control intervention for people with aphasia: a quasi-randomised controlled feasibility study. Woolf, C., Caute, A., Haigh, Z., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-aphasia-5-2023-05cc5

Telemedicine Interventions for Aphasia (PICTURE IT Trial) A home-based, computer-delivered intervention significantly reduced communication difficulties in 20 adults with chronic aphasia, showing a decrease of 6.79 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3002597/

Implementation of Computer-Based Language Therapy in ... The results of this study suggest that computer-based language therapy can lead to positive changes in the language and functional communication skills of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11853447/

Computer- and Smart-Tablet-Based Self-Administered ... There is also evidence that computer-delivered therapy is effective compared to no therapy and is as effective as clinician-delivered therapy [ ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0021992421000812

Effects of computer-based therapy versus therapist ... Participants in both computer-based and traditional therapist-mediated aphasia intervention showed significant gains in language skills, functional ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/02687038.2024.2384542

Aphasia therapy software: an investigation of the research ... Oral Reading for Language in Aphasia (ORLA): Evaluating the efficacy of computer-delivered therapy in chronic nonfluent aphasia. Topics in Stroke ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10537631/

Therapies and Challenges in the Post-Stroke Aphasia ... Overall, currently no pharmacological interventions for aphasia are approved by the United States Food and Drug Administration (FDA) [18], and, ...

7. tandfonline.com tandfonline.com/doi/full/10.1080/02687038.2023.2282659

The effects of cognitive-linguistic interventions to treat ... Evidence for the effects of cognitive-linguistic intervention for aphasia in the first 90 days post-stroke is inconclusive. Intervention approaches included ...

8. j-stroke.org j-stroke.org/journal/view.php?viewtype=pubreader&number=373

Current Approaches to the Treatment of Post-Stroke Aphasia These trials include evaluation of behavioral therapies and computer-delivered language therapies. We also discuss outcome prediction trials as ...