Speech-Language Therapy for Aphasia

(TERRA Trial)

Recruiting at 2 trial locations

Overseen By Kelli Powell, B.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of South Carolina

Disqualifiers: Neurological disease, Severe speech issues, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of remotely delivered speech-language therapy compared to traditional in-clinic sessions for people with aphasia, a condition that affects communication skills after a stroke. Participants will engage in both semantically-focused (meaning-based) and phonologically-focused (sound-based) therapy tasks. The trial aims to determine if online therapy can be as beneficial as face-to-face sessions. Ideal candidates are those who experienced a stroke affecting the left side of the brain at least a year ago and primarily speak English. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve access to effective therapy for others with similar conditions.

Will I have to stop taking my current medications?

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

What prior data suggests that these therapy methods are safe for aphasia treatment?

Research has shown that both sound-focused and meaning-focused therapy tasks are generally safe for people with aphasia. These therapies are well-known and have been used to improve language skills after a stroke.

Studies have found that phonological components analysis, a part of sound-focused therapy, is a popular method for helping people find words more easily. Strong evidence supports its use, and it has been applied successfully without reports of serious side effects.

Similarly, semantic feature analysis, a meaning-focused therapy, is widely used. It aids people with aphasia by concentrating on the meanings of words. This technique is well-tolerated and has shown positive results in improving language abilities.

Overall, these therapies are considered safe and effective for those seeking to improve their speech and language skills after a stroke. No significant adverse events are commonly associated with these treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these speech-language therapy methods for aphasia because they offer a fresh approach to rehabilitation. Unlike traditional in-person therapy sessions, the Aphasia Remote Therapy (ART) allows participants to engage in treatment from home, using an online platform and teletherapy kits, which could make therapy more accessible and convenient. Meanwhile, the In-Clinic Therapy (I-CT) maintains the standard face-to-face interaction, ensuring comprehensive support from a speech-language pathologist. Both treatments uniquely combine semantically and phonologically-focused tasks, potentially enhancing the effectiveness of therapy by targeting different language processing areas. By examining the order and setting of these treatments, researchers hope to uncover optimal strategies for improving communication in people with aphasia.

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

Research has shown that two types of therapy tasks can help people with aphasia improve their ability to find words and communicate. In this trial, participants will receive both types of therapy. One type, Phonological Components Analysis, focuses on the sounds in words. This method helps people find words by breaking them down into individual sounds, and studies have shown it can greatly improve naming skills. The other type, Semantic Feature Analysis, focuses on the meanings of words. This approach helps by having people describe the features of words, and it has been effective in improving naming difficulties. Both therapy methods have shown promise in aiding recovery from aphasia. ^{1 6 7 8 9}

Who Is on the Research Team?

Julius Fridriksson, Ph.D

Principal Investigator

University of South Carolina

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 21-80 who've had a left hemisphere stroke at least a year ago and can consent to treatment. They must be MRI compatible without metal implants or claustrophobia, and have no history of other brain diseases or severe speech/comprehension impairments.

Inclusion Criteria

I am between 21 and 80 years old.

Participants must be magnetic resonance imaging (MRI) compatible (e.g., no metal implants, not claustrophobic) on a 3-Tesla (3T) scanner.

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

Exclusion Criteria

I have no history of brain injuries or neurological diseases.

I have not had a stroke affecting both sides of my brain or in the cerebellum or brainstem.

I can speak and understand well enough to participate in therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3 weeks of daily semantically-focused treatment and 3 weeks of daily phonologically-focused treatment, either remotely or in-clinic

6 weeks

Daily sessions (remote or in-person)

Follow-up

Participants are monitored for changes in speech production and quality of life after treatment

6 months

Follow-up assessments at 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Phonologically-focused therapy tasks
• Semantically-focused therapy tasks

Trial Overview The TERRA study compares two types of speech-language therapy for aphasia after a stroke: one delivered remotely (ART) and the other in-clinic (I-CT). It aims to see if telerehabilitation is as effective as traditional methods.

How Is the Trial Designed?

Group I: Aphasia Remote Therapy (ART) Experimental Treatment 2 Interventions

All participants in this group will receive 3 weeks of daily semantically-focused treatment (semantic feature analysis, semantic barrier task and verb network strengthening therapy) and 3 weeks of daily phonologically-focused treatment (phonological components analysis, phonological production task, phonological judgment task). Participants will be randomized to order of treatment. All treatment will be done remotely with a speech-language pathologist through an online platform using therapy applications. Participants will be provided with teletherapy kits (including an Internet hotspot if needed) to complete the therapy tasks.

Group II: In-Clinic Therapy (I-CT) Active Control 2 Interventions

All participants in this group will receive 3 weeks of daily semantically-focused treatment (semantic feature analysis, semantic barrier task and verb network strengthening therapy) and 3 weeks of daily phonologically-focused treatment (phonological components analysis, phonological production task, phonological judgment task). Participants will be randomized to order of treatment. All treatment will be done in person with a speech-language pathologist at the UofSC Aphasia Lab.

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials

233

Recruited

122,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

Published Research Related to This Trial

In a study involving three chronic aphasia speakers, Phonological Cueing Treatment (PCT) and Semantic Cueing Treatment (SCT) were tested for their effectiveness in improving action naming, with positive results for some participants.

Action naming improved for Speaker 1 (who received SCT) and Speaker 3 (who received both treatments), indicating that these cueing treatments can be beneficial for certain individuals with aphasia, though results may vary depending on the type of treatment and the grammatical category of the words.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of two lexical retrieval cueing treatments on action naming in aphasia. Wambaugh, JL., Doyle, PJ., Martinez, AL., et al.[2009]

In a study of 104 individuals with chronic post-stroke aphasia, semantically focused treatment was found to be more effective than phonologically focused treatment for improving naming performance, regardless of treatment order.

Participants with milder speech impairments and fluent speech were more likely to respond positively to semantic treatment, while those with more severe impairments and apraxia of speech benefited more from phonological treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized response to semantic versus phonological aphasia therapies in stroke. Kristinsson, S., Basilakos, A., Elm, J., et al.[2022]

Semantic feature analysis is an effective intervention for improving naming abilities in individuals with aphasia, as shown by a review of 11 studies that utilized single subject research designs.

While most participants showed a small effect size using Cohen's d, a large treatment effect was observed when calculating the percent of non-overlapping data, indicating significant improvements in confrontational naming for many individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of semantic feature analysis: an evidence-based systematic review. Maddy, KM., Capilouto, GJ., McComas, KL.[2018]

Semantic Feature Analysis (SFA) has been shown to improve naming abilities in 81.82% of participants with aphasia, based on a review of 21 studies involving 55 individuals.

The studies reviewed demonstrated a small treatment effect, indicating that while SFA is beneficial, further research is needed to better understand its efficacy and how well improvements generalize to everyday communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Semantic Feature Analysis Therapy Studies for Aphasia. Efstratiadou, EA., Papathanasiou, I., Holland, R., et al.[2019]

The study used a single-participant design with four participants to compare the effects of Semantic Feature Analysis (SFA) and Phonological Components Analysis (PCA) therapies on naming outcomes in individuals with aphasia.

Results showed that the effectiveness of each therapy varied among participants, influenced by factors like the severity of their naming difficulties (anomia) and the order in which treatments were given, suggesting that personalized approaches are crucial for effective intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case series comparison of semantically focused vs. phonologically focused cued naming treatment in aphasia. Neumann, Y.[2018]

The study demonstrated that a working memory and modified Semantic Feature Analysis approach was successfully completed by all three participants with mild to moderate aphasia, indicating its feasibility for this population.

Participants showed significant improvements in naming performance and working memory abilities after treatment, suggesting that this approach may effectively help remediate word finding deficits in individuals with aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a combined working memory - Semantic feature analysis approach to treat anomia in aphasia: A Pilot Study. Hashimoto, N.[2023]

In a study of eight individuals with aphasia, phonologically-based treatment (Phonological Components Analysis, PCA) led to significant improvements in naming accuracy for seven participants, with most maintaining these gains at follow-up.

Semantic therapy (Semantic Feature Analysis, SFA) was less effective, particularly for those with semantic deficits, highlighting the importance of matching treatment approaches to individual word retrieval breakdowns for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of semantic feature analysis and phonological components analysis for the treatment of naming impairments in aphasia. van Hees, S., Angwin, A., McMahon, K., et al.[2022]

In a study involving 10 individuals with aphasia, phonological cues were found to be more effective than semantic cues for improving picture naming accuracy, particularly for items with low visual complexity.

The results suggest that phonological cues aid in the initial categorization of pictures rather than directly mapping to phonological processes, which has important implications for developing more effective rehabilitation therapies for naming impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Does a Cue Do? Comparing Phonological and Semantic Cues for Picture Naming in Aphasia. Meteyard, L., Bose, A.[2019]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0361923025000814

A systematic review of Phonological Components Analysis ... Among the wide range of anomia treatments for persons with aphasia (PWA), Phonological Components Analysis (PCA) is a well-known alternative.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10205105/

Predicting Outcomes of Language Rehabilitation Aphasia severity, age, education, time postonset, and cognitive reserve predict naming gains at 1 week, 1 month, and 6 months posttherapy.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04682223

NCT04682223 | Telerehabilitation for Aphasia (TERRA) Speech-language therapy is generally found to be helpful in the rehabilitation of aphasia. However, not all patients with aphasia have access to adequate ...

4. alliedhealth.ceconnection.com alliedhealth.ceconnection.com/files/ThePhonomotorApproachtoTreatingPhonologicalBasedLanguageDeficitsinPeopleWithAphasia-1461945148748.pdf

The Phonomotor Approach to Treating Phonological-Based ... The phonomotor treatment program for treating word-retrieval deficits among people with aphasia is inspired by a parallel distributed processing model of ...

5. tactustherapy.com tactustherapy.com/pca-phonological-components-analysis-aphasia/

Phonological Components Analysis for Aphasia Phonological components analysis is an evidence-based speech therapy technique to improve word-finding in aphasia. Learn how with a free download.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8189855/

Current Approaches to the Treatment of Post-Stroke Aphasia Supported by evidence from Phase III trials and large meta-analyses, it is now generally accepted that aphasia therapy can improve language processing for many ...

7. researchgate.net researchgate.net/publication/389370181_A_systematic_review_of_Phonological_Components_Analysis_therapy_studies_for_aphasia

A systematic review of Phonological Components Analysis ... SFA enhances lexical retrieval by training persons with aphasia to generate and reflect on semantic attributes related to target words, ...

8. theadultspeechtherapyworkbook.com theadultspeechtherapyworkbook.com/phonological-components-analysis/

Phonological Components Analysis: A Step-By-Step Guide In this article, you'll find a step-by-step guide to phonological component analysis for speech therapy, with charts and examples.

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40015347/

A systematic review of Phonological Components Analysis ... Among the wide range of anomia treatments for persons with aphasia (PWA), Phonological Components Analysis (PCA) is a well-known alternative.