Script Training for Aphasia

(MIDAS Trial)

Overseen By Laura Kinsey, MS, CCC-SLP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Disqualifiers: Parkinson's, Alzheimer's, Brain injury, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 2-5 weeks

95 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate how changing conditions of speech-language treatment (namely, amount of repetition and distribution of practice schedule) affects the language outcome of participants with aphasia following a stroke. Using a computer based speech and language therapy program, participants will practice conversational scripts that are either short or long. Participants will practice for either 2 weeks (5 days a week) or for 5 weeks (2 days a week).

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

The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that participants should not be receiving speech-language therapy at the time of the study.

What data supports the effectiveness of the treatment Script Training for Aphasia?

Research shows that script training, including computer-based methods, can significantly improve speech and language skills in people with aphasia, helping them use practiced phrases in real conversations. This approach is effective for both stable and progressive forms of aphasia, and improvements can be maintained over time. ^{1 2 3 4 5}

Is script training for aphasia safe for humans?

The research does not report any safety concerns related to script training for aphasia, suggesting it is generally safe for humans. ^{1 4 5 6 7}

How is script training for aphasia different from other treatments?

Script training for aphasia is unique because it involves practicing specific phrases and sentences repeatedly, which can be used in real-life conversations. This treatment can be delivered via computer with a virtual clinician, allowing for flexible and intensive practice, and it has been shown to improve communication in both stable and progressive forms of aphasia. ^{1 2 3 5 8}

Research Team

Leora Cherney, PhD, CCC-SLP

Principal Investigator

Shirley Ryan Abilitylab, Northwestern University

Eligibility Criteria

This trial is for men and women who have aphasia after a left-hemisphere stroke. They should be at least 6 months post-stroke, with an Aphasia Quotient score of 40-80 on the Western Aphasia Battery-Revised. Participants must have completed eighth grade, be literate in English, not currently receiving speech therapy, and have adequate vision and hearing. Those with active substance abuse, other neurological conditions affecting cognition/speech or significant psychiatric history are excluded.

Inclusion Criteria

Completed at least eighth grade education

Premorbidly literate in English

I am not currently undergoing speech-language therapy.

Exclusion Criteria

I have a psychiatric history but am stable on treatment.

You are currently using drugs or alcohol excessively.

I do not have any brain conditions like Parkinson's or Alzheimer's that affect my thinking or speech.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants practice conversational scripts using a computer-based speech and language therapy program. The practice varies between 2 weeks (5 days a week) and 5 weeks (2 days a week) depending on the assigned group.

2-5 weeks

10-25 sessions (virtual)

Follow-up

Participants are monitored for maintenance of trained script and generalization of conversation skills.

6 weeks

Treatment Details

Interventions

• Modulating Intensity and Dosage of Aphasia Scripts

Trial Overview The study tests how different speech-language treatment schedules affect language recovery in aphasic patients post-stroke. Using computer-based therapy to practice conversational scripts that vary in length, participants will follow either a high-intensity schedule (5 days/week for 2 weeks) or a low-intensity schedule (2 days/week for 5 weeks).

Participant Groups

Group I: Massed, Short Script Experimental Treatment 1 Intervention

Participant practices for 1 hour, 5 days a week for 2 weeks using a 5 sentence-long script.

Group II: Massed, Long Script Experimental Treatment 1 Intervention

Participant practices for 1 hour, 5 days a week for 2 weeks using a 10 sentence-long script.

Group III: Distributed, Short Script Experimental Treatment 1 Intervention

Participant practices for 1 hour, 2 days a week for 5 weeks using a 5 sentence-long script.

Group IV: Distributed, Long Script Experimental Treatment 1 Intervention

Participant practices for 1 hour, 2 days a week for 5 weeks using a 10 sentence-long script.

Modulating Intensity and Dosage of Aphasia Scripts is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Speech-Language Therapy for:

• Aphasia following stroke

Approved in European Union as Speech-Language Therapy for:

• Aphasia following stroke
• Language disorders

Approved in Canada as Speech-Language Therapy for:

• Aphasia following stroke
• Language disorders

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

University of Colorado, Boulder

Collaborator

Trials

128

Recruited

29,600+

Findings from Research

A single 60-minute session of computer-delivered script training significantly improved oral reading accuracy and script production in 20 participants with chronic aphasia, indicating that even one dose can be effective for learning.

Participants also showed significant improvements in their ability to generalize the trained script to real conversations, suggesting that this training method can enhance practical communication skills over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimising recovery in aphasia: Learning following exposure to a single dose of computer-based script training. Cherney, LR., Braun, EJ., Lee, JB., et al.[2022]

Script training is an effective therapy for individuals with stable and progressive aphasia, allowing them to learn and maintain scripted speech, with evidence of generalization to untrained topics.

The approach utilizes principles of neuroplasticity and can be adapted to various settings, including individual and group therapy, making it a versatile tool for rehabilitation after brain injuries like stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Script Training Improve Narrative and Conversation in Aphasia across Etiology? Hubbard, HI., Nelson, LA., Richardson, JD.[2021]

Script training was effective for individuals with apraxia of speech (AOS), as all three participants successfully acquired and retained their client-selected scripts for up to 6 months after treatment.

Participants reported increased confidence and ease in speaking, indicating that script training not only helped with retention but also improved their overall communication experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Script training treatment for adults with apraxia of speech. Youmans, G., Youmans, SR., Hancock, AB.[2016]

The modified script training intervention, which included both in-person and videoconferencing sessions, significantly improved accuracy, grammatical productivity, speaking rate, and articulatory fluency in two individuals with aphasia over a 3-week period for each script.

Participants also demonstrated the ability to generalize their improved skills to functional conversational tasks, indicating that the intervention was effective not only in structured settings but also in real-life communication scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Script training and generalization for people with aphasia. Goldberg, S., Haley, KL., Jacks, A.[2022]

A study involving eight individuals with chronic non-fluent aphasia demonstrated that using low-difficulty scripts significantly improved oral reading accuracy compared to high-difficulty scripts, regardless of the severity of aphasia.

The results support the effectiveness of using graded script templates tailored to individual abilities, which can enhance communication training for people with aphasia in both clinical and research settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Script Templates: A Practical Approach to Script Training in Aphasia. Kaye, RC., Cherney, LR.[2020]

In a study involving 34 adults with chronic post-stroke aphasia, distributed therapy (6 hours per week for 8 weeks) led to significantly greater improvements in language impairment, as measured by the Boston Naming Test, compared to intensive therapy (16 hours per week for 3 weeks).

Both therapy schedules resulted in similar gains in communicative effectiveness, confidence, and quality of life, suggesting that while distributed therapy may be more effective for language impairment, both approaches positively impact overall communication outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive Versus Distributed Aphasia Therapy: A Nonrandomized, Parallel-Group, Dosage-Controlled Study. Dignam, J., Copland, D., McKinnon, E., et al.[2016]

Intensive speech-language therapy can lead to significant improvements in aphasia treatment, but the concept of 'intensity' lacks a standard definition and is not simply about doing more therapy sessions.

Research indicates that the effectiveness of aphasia treatment depends not only on the intensity of therapy but also on the specific strategies and active components used during the sessions, highlighting the need for a more nuanced approach to treatment design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aphasia treatment: intensity, dose parameters, and script training. Cherney, LR.[2021]

In a study involving 8 individuals with chronic aphasia, personalized words and phrases were learned more effectively than generic ones during intensive script training, showing a large effect size (d = 0.90) for trained scripts.

While both personalized and generic items improved in trained scripts, only personalized items showed significant improvement in untrained generalization scripts, indicating that personalization may enhance learning but does not guarantee generalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Personal Relevance on Acquisition and Generalization of Script Training for Aphasia: A Preliminary Analysis. Cherney, LR., Kaye, RC., Lee, JB., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Optimising recovery in aphasia: Learning following exposure to a single dose of computer-based script training. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Can Script Training Improve Narrative and Conversation in Aphasia across Etiology? [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Script training treatment for adults with apraxia of speech. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Script training and generalization for people with aphasia. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Script Templates: A Practical Approach to Script Training in Aphasia. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Intensive Versus Distributed Aphasia Therapy: A Nonrandomized, Parallel-Group, Dosage-Controlled Study. [2016]

7. England pubmed.ncbi.nlm.nih.gov

Aphasia treatment: intensity, dose parameters, and script training. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Impact of Personal Relevance on Acquisition and Generalization of Script Training for Aphasia: A Preliminary Analysis. [2019]