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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different speech-language therapy schedules impact language improvement in people with aphasia after a stroke. Participants will use a computer-based program to practice conversational scripts, varying in length and frequency: short scripts for five weeks or long scripts for two weeks. It suits those diagnosed with aphasia, who experienced a stroke affecting the left side of the brain, and have not been receiving other speech therapy.

As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance therapy options for aphasia.

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 prior data suggests that this speech-language therapy is safe for individuals with aphasia?

Studies have shown that intensive speech-language therapy can greatly benefit people with aphasia, a condition affecting communication. This therapy involves practicing language skills and is generally well-received by most participants. Specific information about negative effects from this therapy is lacking, as it focuses on practicing set phrases to improve speech.

Since the study does not involve new medications or surgical procedures, the risks are generally lower compared to other clinical trials. Participants will use a computer program to practice these phrases, providing a safe way to enhance language skills after a stroke. Overall, research suggests that this therapy is safe and can improve communication for people with aphasia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Script Training for Aphasia trial because it explores how varying the intensity and dosage of practice can improve language recovery. Unlike traditional speech therapy methods that might have a more uniform approach, this trial examines different schedules and script lengths to see what combination works best for people with aphasia. By testing both distributed practice (spread out over weeks) and massed practice (condensed into a shorter time frame), this trial could lead to more personalized and effective treatment plans for aphasia patients.

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

Studies have shown that intensive speech-language therapy can greatly help people with aphasia, a condition affecting communication, often after a stroke. Research indicates that both the amount of practice and its distribution over time can influence recovery. In this trial, participants will join different treatment arms to explore these variables. For example, one arm involves a single 60-minute session of script training using a computer, which improved both reading accuracy and script production in participants. This suggests that adjusting the intensity and timing of practice might enhance language skills in those with aphasia. ^{1 2 3 4 6}

Who Is on the Research Team?

Leora Cherney, PhD, CCC-SLP

Principal Investigator

Shirley Ryan Abilitylab, Northwestern University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

Citations

1. ctv.veeva.com ctv.veeva.com/study/modulating-intensity-and-dosage-of-aphasia-scripts

Modulating Intensity and Dosage of Aphasia Scripts (MIDAS) This study investigates the effects of modulating stimulus variables, specifically stimulus practice distribution and stimulus repetition. We ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3698219/

Aphasia treatment: Intensity, dose parameters, and script ... Studies of aphasia treatment have shown that intensive speech-language therapy is associated with significant improvements.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22731660/

Aphasia treatment: intensity, dose parameters, and ... - PubMed Studies of aphasia treatment have shown that intensive speech-language therapy is associated with significant improvements.

4. researchgate.net researchgate.net/publication/228064953_Aphasia_treatment_Intensity_dose_parameters_and_script_training

Aphasia treatment: Intensity, dose parameters, and script ... Abstract Studies of aphasia treatment have shown that intensive speech-language therapy is associated with significant improvements.

5. withpower.com withpower.com/trial/phase-aphasia-8-2020-7f52d

Script Training for Aphasia (MIDAS Trial) A single 60-minute session of computer-delivered script training significantly improved oral reading accuracy and script production in 20 participants with ...

6. researchgate.net researchgate.net/publication/246428811_Conversational_script_performance_in_adults_with_non-fluent_aphasia_Treatment_intensity_and_aphasia_severity

Treatment intensity and aphasia severity | Request PDF Conversational script performance in adults with non‐fluent aphasia: Treatment intensity and aphasia severity. Taylor & Francis. Aphasiology.