Speech-Language Therapy for Aphasia

Overseen By Fatima Jebahi, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Disqualifiers: Mood disorders, Anxiety, Psychotic, others

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

Compensation: Varies

Number of Visits: 24

Duration: 10 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of language-based treatments for people with aphasia, a condition that impairs understanding, speaking, reading, or writing due to brain damage from a stroke or dementia. Participants will receive either personalized speech-language training (individualized speech-language therapy) or a standard language intervention. The trial will also examine brain activity patterns to assess long-term effects. It is best suited for native English speakers with aphasia from a stroke or dementia who can undergo MRI scans (a type of brain imaging). As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future aphasia treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Past studies have shown that speech and language therapy for people with aphasia is well-tolerated. Research indicates that these therapies can improve communication skills without significant side effects. One study examined 73 cases of speech-language therapy for aphasia after a stroke and found it effective and safe. Another study in Ghana reported positive results without major issues. Although this therapy is not a drug, it is reassuring that most patients have responded well to speech-language interventions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the individualized speech-language training because it tailors therapy to each person's specific language abilities, focusing on semantic and phonological strategies to improve word-finding and sentence formulation. Unlike standard interventions that adopt a one-size-fits-all approach, this treatment's personalized nature means it adapts to the participant's performance level, potentially leading to more effective outcomes. By targeting the unique language challenges of each individual, this method offers a promising advancement in the way aphasia is treated, potentially enhancing the effectiveness of therapy and speeding up recovery.

What evidence suggests that these speech-language therapies could be effective for aphasia?

Research shows that speech-language therapy can help people with aphasia. In this trial, participants will divide into two groups: one receiving individualized speech-language training and the other undergoing standard language intervention. Studies have found that intensive speech and language therapy (SLT) improves language skills in those with long-term aphasia. A review of research found that SLT works better than no treatment for people recovering from a stroke. Additionally, receiving more than 20 hours of SLT can lead to significant improvements. Overall, participating in organized speech and language therapy can noticeably enhance communication abilities for those with aphasia. ^{5 6 7 8 9}

Who Is on the Research Team?

Aneta Kielar, PhD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

This trial is for English-speaking adults with aphasia due to stroke or dementia, who can undergo MRI scans and have normal vision and hearing (with aids if needed). It's not for those with severe health issues, claustrophobia, metal implants incompatible with MRI, substance abuse history, recent seizures, brain surgery history, or psychiatric conditions affecting communication.

Inclusion Criteria

I have difficulty speaking or understanding language due to a stroke or dementia.

I have been diagnosed with primary progressive aphasia by a doctor.

My vision and hearing are normal or corrected to normal.

Exclusion Criteria

I do not have severe illnesses like kidney failure.

You have metal implants that could affect the quality of MRI images.

I have had brain surgery before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo baseline cognitive and language assessment, EEG recording, and MRI scan

1 week

1 visit (in-person)

Treatment

Participants receive individualized language treatment twice a week for 10 weeks

10 weeks

20 visits (in-person)

Post-Treatment Assessment

Participants undergo cognitive and language assessment, EEG recording, and MRI scan to test for short-term changes

1 week

1 visit (in-person)

Follow-up

Participants are monitored for long-term changes in behavioral abilities and neural responses

2 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Individualized Speech-Language Training
• Standard Language Intervention

Trial Overview The study compares individualized speech-language training versus standard language intervention in improving communication skills among people with aphasia. It also examines the long-term effects of these treatments and their associated neural patterns through brain imaging.

How Is the Trial Designed?

Group I: Active therapy group Experimental Treatment 1 Intervention

Participants will undergo individualized language treatment in which they will learn semantically- or phonologically based strategies to facilitate word finding difficulties, sentence formulation difficulties, or challenges in their narration and discourse. The level at which the treatment will be administered will depend on the participants' level of performance determined by the results of the language and cognitive testing done at baseline. Treatment will be administered twice a week for 10 weeks.

Group II: control group Active Control 1 Intervention

control group will undergo standard speech-language intervention

Individualized Speech-Language Training is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Speech-Language Therapy for:

• Aphasia
• Language Impairment
• Communication Disorders

Approved in Canada as Speech-Language Pathology for:

• Aphasia
• Language Impairment
• Communication Disorders

Approved in European Union as Aphasia Therapy for:

• Aphasia
• Language Impairment
• Communication Disorders

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Published Research Related to This Trial

Independent computerized aphasia therapy is generally acceptable to stroke survivors, providing benefits such as flexibility, independence, and personalized practice that can improve word-finding and confidence.

To enhance the acceptability of this therapy, it is important to tailor exercises to individual interests, ensure adequate support for motivation and technical help, and consider the potential for fatigue and lifestyle impacts when scheduling practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using computers to enable self-management of aphasia therapy exercises for word finding: the patient and carer perspective. Palmer, R., Enderby, P., Paterson, G.[2022]

Language-based therapy for aphasia is grounded in neurological principles and linguistic theories, providing a structured approach to treatment.

Communicative therapy extends traditional language-based methods and is supported by Hughlings Jackson's language theory, with examples including computer training programs designed to enhance communication skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New approaches in speech therapy]. Pulvermüller, F., Roth, VM., Schönle, PW.[2006]

Donepezil has been shown to significantly improve various aspects of language function in patients with post-stroke aphasia, including auditory comprehension, naming, repetition, and oral expression, based on a systematic review of 15 studies involving 578 participants.

Memantine also demonstrated efficacy in enhancing naming ability, spontaneous speech, and repetition, although it did not show significant improvement in auditory comprehension, indicating that different pharmacological treatments may have varying effects on language recovery after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy and Safety of Pharmacological Treatments for Post-stroke Aphasia. Zhang, X., Shu, B., Zhang, D., 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]

A systematic review of aphasia research datasets revealed significant gaps in participant and intervention details, with only 25.8% of studies reporting prior stroke information and just 2.3% providing socio-economic status, which are crucial for understanding treatment outcomes.

While basic participant demographics like age and sex were commonly reported, the lack of detailed intervention descriptions limits the ability to replicate studies and apply findings in clinical practice, highlighting the need for improved reporting standards in aphasia research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communicating simply, but not too simply: Reporting of participants and speech and language interventions for aphasia after stroke. [2022]

This study is a randomized controlled trial involving 126 patients with chronic aphasia, aiming to evaluate the effectiveness of intensive speech and language therapy (SLT) in improving everyday communication after stroke.

Participants will undergo at least 10 hours of therapy per week for three weeks, with outcomes measured using standardized tests to assess functional communication, providing robust evidence for the efficacy of SLT in chronic aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FCET2EC (From controlled experimental trial to = 2 everyday communication): How effective is intensive integrative therapy for stroke-induced chronic aphasia under routine clinical conditions? A study protocol for a randomized controlled trial. Baumgaertner, A., Grewe, T., Ziegler, W., et al.[2021]

Aphasia, a language processing disorder often resulting from stroke, can lead to significant disability and increased mortality, but most patients show some degree of recovery.

Speech and language therapy has been proven effective in treating aphasia after a stroke, while other treatment methods like pharmacotherapy and transcranial magnetic stimulation are currently under investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aphasia and other language disorders. de Freitas, GR.[2012]

The study aims to create a comprehensive database of individual participant data (IPD) from various studies on speech and language therapy (SLT) for people with aphasia after stroke, which will help identify predictors of recovery and effective therapy components.

By using meta- and network meta-analysis, the research will explore how individual characteristics and specific SLT interventions contribute to improvements in language recovery, ultimately aiming to optimize treatment strategies for aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RELEASE: a protocol for a systematic review based, individual participant data, meta- and network meta-analysis, of complex speech-language therapy interventions for stroke-related aphasia. Brady, MC., Ali, M., VandenBerg, K., et al.[2023]

Aphasia, often resulting from stroke, significantly impacts a person's autonomy and quality of life, highlighting the need for effective treatment strategies.

Combining impairment-based approaches with functionally oriented interventions, while considering the International Classification of Functioning Disability and Health (ICF) framework, can create a comprehensive and personalized treatment plan for individuals with aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impairment and Functional Interventions for Aphasia: Having it All. Galletta, EE., Barrett, AM.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11561048/

Success rates of intensive aphasia therapy: real-world data ... Studies have shown that intensive speech and language therapy (SLT) is effective in the chronic phase of aphasia.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7614912/

RELEASE: a protocol for a systematic review based, individual ... The recent Cochrane systematic review of speech and language therapy (SLT) for aphasia after stroke demonstrated the effectiveness of SLT compared to no SLT on ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S240584402417404X

Exploring benefits of speech and language therapy ... This study examines the perceived benefits of speech and language therapy interventions for people with aphasia in Ghana

4. pubs.asha.org pubs.asha.org/doi/10.1044/2025_PERSP-24-00260

The Efficacy and Utility of Constant Therapy in Poststroke ... Individuals with poststroke aphasia benefit significantly from high-intensity speech-language therapy (SLT) due to its ability to drive ...

5. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.121.035216

Dosage, Intensity, and Frequency of Language Therapy ... Greatest gains in overall language and comprehension were associated with >20 to 50 hours SLT dosage (18.37 [10.58–26.16] Western Aphasia ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8078645/

Speech and language therapy for aphasia following stroke We present data from 73 randomised comparisons as they relate to the effectiveness of SLT for aphasia following stroke.

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

Current Approaches to the Treatment of Post-Stroke Aphasia Emerging evidence from Phase II trials suggests transcranial brain stimulation is a promising method to boost aphasia therapy outcomes. Keywords: Language ...

8. withpower.com withpower.com/trial/phase-pick-disease-of-the-brain-7-2022-d0498

Speech-Language Therapy for Aphasia Trial Overview The study compares individualized speech-language training versus standard language intervention in improving communication skills among people ...

9. tandfonline.com tandfonline.com/doi/full/10.1080/02687038.2023.2253994

Development of an evidence-based aphasia therapy ... Outcomes & Results. Eligible responses from 176 speech pathologists across 19 countries were included in the analyses (86.3% completion rate).