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

Trial Summary

What is the purpose of this trial?

Aphasia is an acquired impairment of language, that commonly results from damage to language areas in the brain (typically the left side of the brain). This impairment is seen in many aspects of language, including understanding, speaking, reading and writing. It is estimated that about 2 million individuals are currently living with aphasia in the United States. Further, about 200,000 Americans acquire aphasia every year (National Aphasia Association, 2020). Aphasia poses significant impact on the affected individuals and their families. Behavioral treatments that target language deficits have been shown to enhance overall communication skills and life satisfaction among individuals with aphasia. Although there is evidence that suggests that treatment is efficacious for individuals with aphasia, the extent of improvement long-term coupled with the neural patterns among those individuals are largely unknown. The current study aims to investigate the efficacy of language-based treatment and its corresponding neural patterns.

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.

Is speech-language therapy for aphasia generally safe for humans?

The available research does not specifically address the safety of speech-language therapy for aphasia, but it is widely recommended as a standard treatment, suggesting it is generally considered safe. ^{1 2 3 4 5}

How is the Individualized Speech-Language Training treatment for aphasia different from other treatments?

Individualized Speech-Language Training for aphasia is unique because it focuses on intensive, personalized therapy sessions that aim to improve everyday communication skills, unlike some other treatments that may not be as tailored or intensive. This approach combines both impairment-based and functional methodologies, making it a comprehensive and person-centered option for those with chronic aphasia. ^{1 6 7 8 9}

Research Team

Aneta Kielar, PhD

Principal Investigator

University of Arizona

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2021]

2. England 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. [2023]

3. United Arab Emirates pubmed.ncbi.nlm.nih.gov

The Efficacy and Safety of Pharmacological Treatments for Post-stroke Aphasia. [2019]

4. England pubmed.ncbi.nlm.nih.gov

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

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

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

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

Using computers to enable self-management of aphasia therapy exercises for word finding: the patient and carer perspective. [2022]

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

Impairment and Functional Interventions for Aphasia: Having it All. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Aphasia and other language disorders. [2012]

9. Germany pubmed.ncbi.nlm.nih.gov

[New approaches in speech therapy]. [2006]