Adaptive Naming Treatment Schedules for Aphasia

Overseen By Alyssa Kelly, M.A., CCC-SLP

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Pittsburgh

Disqualifiers: Neurological disease, Language comprehension, Drug/alcohol dependence, Mood/behavioral disorders

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 56

Duration: 10 weeks per condition

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to help people with aphasia, a language disorder often caused by stroke, improve their ability to find and use words in everyday life. The study tests various methods of teaching word naming through pictures, focusing on how well participants remember and use these words over time. Participants will try three different treatment schedules, including the Adaptive Spacing Condition, to determine which most effectively aids word retention and daily use. The trial seeks individuals who have experienced aphasia for more than six months following a left hemisphere stroke and have access to high-speed internet for telehealth participation. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in aphasia treatment.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the adaptive naming treatment methods tested in this study are generally safe for people with aphasia. Although specific safety details aren't always highlighted in existing research, similar treatments have been used without major safety concerns.

For the adaptive spacing condition, available studies have not reported specific safety issues. Previous research indicates that adaptive methods are effective and manageable for people with aphasia, suggesting they are well-tolerated.

For the high-item and low-item non-adaptive spacing conditions, studies have shown positive effects on word-finding abilities without noting any negative effects, indicating these methods are likely safe.

Since this trial is in a middle stage, earlier studies have likely demonstrated a good level of safety. However, participants should still pay attention to any specific instructions or potential risks provided by the trial team. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for aphasia because they explore different ways to improve language recovery through varied naming practice schedules. Unlike the standard approach, which often involves repetitive speech therapy exercises, these new methods use adaptive and non-adaptive spacing to enhance learning. Adaptive spacing adjusts to the individual's progress, potentially making treatment more personalized and effective. By testing combinations of high-item and low-item non-adaptive spacing, researchers aim to find the most efficient way to help patients regain their naming abilities, offering hope for more tailored and impactful aphasia rehabilitation strategies.

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

Research has shown that spreading out practice sessions over time, known as adaptive spacing, can help people with aphasia learn better. This trial will evaluate different naming treatment conditions, including adaptive and non-adaptive spacing methods. Studies have found that treatments focused on naming pictures, whether using adaptive spacing or not, can significantly improve naming ability. Both high and low amounts of practice, when conducted through telepractice (online sessions), are as effective as in-person sessions. Additionally, digital therapies have led to an average improvement of 29 more words. Overall, these methods show promise in helping people with aphasia find words more easily. ^{1 2 5 6 7}

Who Is on the Research Team?

William Evans, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for people who have had a stroke leading to aphasia, a language disorder, and struggle with finding words. They must be at least six months post-stroke, show specific difficulties on the Comprehensive Aphasia Test, and can use telehealth services via high-speed internet. It's not for those with other neurological diseases, severe comprehension issues, uncontrolled substance dependence or serious mood disorders.

Inclusion Criteria

I have had difficulty speaking for over 6 months due to a stroke.

You have trouble with at least two out of eight parts of the Comprehensive Aphasia Test.

Must have access to a high-speed internet connection and be able to participate in telehealth.

Exclusion Criteria

You have trouble understanding and speaking language, based on a specific test score.

I have a severe mood or behavioral disorder that needs special mental health care.

I have a history of a progressive neurological condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

2 visits (telehealth)

Treatment

Participants receive 10 weeks of computer-based training per condition, including one-on-one and independent practice sessions

10 weeks per condition

30 one-on-one sessions, 96 independent practice sessions (telehealth)

Follow-up

Participants are monitored for safety and effectiveness after treatment with probes administered at baseline and at 1 week, 3 months, and 6 months post-treatment

6 months

24 baseline and follow-up probe sessions (telehealth)

What Are the Treatments Tested in This Trial?

Interventions

• Adaptive Spacing Condition
• High-Item Non-Adaptive Spacing Condition
• Low-Item Non-Adaptive Spacing Condition

Trial Overview The study tests three different ways of scheduling picture-based naming exercises to help improve long-term word recall and usage in daily life for individuals with aphasia. Participants will try adaptive spacing (adjusting intervals based on performance), or one of two fixed schedules with varying amounts of practice items.

How Is the Trial Designed?

Group I: Low-item non-adaptive spacing, then high-item non-adaptive spacing, then adaptive spacing Experimental Treatment 3 Interventions

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

Group II: Low-item non-adaptive spacing, then adaptive spacing, then high-item non-adaptive spacing Experimental Treatment 3 Interventions

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

Group III: High-item non-adaptive spacing, then low-item non-adaptive spacing, then adaptive spacing Experimental Treatment 3 Interventions

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

Group IV: High-item non-adaptive spacing, then adaptive spacing, then low-item non-adaptive spacing Experimental Treatment 3 Interventions

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

Group V: Adaptive spacing, then low-item non-adaptive spacing, then high-item non-adaptive spacing Experimental Treatment 3 Interventions

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

Group VI: Adaptive spacing, then high-item non-adaptive spacing, then low-item non-adaptive spacing Experimental Treatment 3 Interventions

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

Adaptive Spacing Condition is already approved in United States for the following indications:

Approved in United States as Adaptive Trial Scheduling for:

• Aphasia
• Anomia

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

University of Massachusetts, Amherst

Collaborator

Trials

83

Recruited

3,474,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

Both fixed-interval spaced retrieval (FISR) and randomized-interval spaced retrieval (RISR) were effective in treating anomia in three individuals with aphasia, indicating that both methods can help improve word retrieval skills.

While FISR required fewer sessions and showed slightly better maintenance of learned items, the minimal differences suggest that a less strict approach like RISR is also effective, making treatment potentially more flexible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing fixed- and randomized-interval spaced retrieval in anomia treatment. Morrow, KL., Fridriksson, J.[2013]

In a study involving 10 individuals with anomic aphasia and 6 healthy adults, repeated naming of objects led to higher accuracy and faster response times compared to naming actions, highlighting the differences in naming efficiency between object and action pictures.

Individuals with anomic aphasia showed variability in response times across trials, unlike healthy participants who improved their response times, suggesting that their retrieval processes may be less efficient and could benefit from targeted interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Response Time Inconsistencies in Object and Action Naming in Anomic Aphasia. Galletta, EE., Goral, M.[2019]

A semantic-based treatment for picture naming was effective for 2 out of 4 individuals with Broca's aphasia, leading to improved naming of both trained and untrained nouns.

For the other 2 participants, improvements in naming only occurred after additional treatment focused on phonological information, highlighting the importance of tailoring therapy to individual needs in lexical processing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Model-based semantic treatment for naming deficits in aphasia. Drew, RL., Thompson, CK.[2019]

Retrieval practice significantly improves naming performance in people with aphasia compared to traditional repetition training, with benefits observed even one month after treatment.

Spacing training sessions (intervening trials) enhances learning outcomes more effectively than massing them together, indicating that both retrieval practice and spacing are important for effective speech-language therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrieval practice and spacing effects in multi-session treatment of naming impairment in aphasia. Middleton, EL., Rawson, KA., Verkuilen, J.[2021]

The study demonstrated that a 12-week computer-based treatment using adaptive distributed practice significantly improved word acquisition, generalization, and retention in two participants with post-stroke aphasia, with one participant acquiring approximately 77 trained words and 63 generalization words.

The results suggest that this method is effective in retraining more words than typically targeted in previous research, while also being accessible through free software, indicating potential for wider clinical use, although larger trials are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying adaptive distributed practice to self-managed computer-based anomia treatment: A single-case experimental design. Quique, YM., Cavanaugh, R., Lescht, E., et al.[2022]

The study compared semantic and phonological feature approaches to improve picture naming in two participants with aphasia, using a modified treatment design that focused on three features instead of six.

Results showed that both approaches led to improved naming abilities, with patterns of naming errors indicating better access to vocabulary, suggesting that a tailored features-based protocol can effectively enhance naming skills in individuals with aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of semantic- and phonological-based feature approaches to treat naming deficits in aphasia. Hashimoto, N.[2012]

In a study involving 72 participants with stroke aphasia, using a distance measure that accounts for item difficulty and response types revealed more significant treatment effects on naming ability compared to standard accuracy measures.

The results suggest that naming ability is made up of different subabilities, indicating that more nuanced measures can better capture the effectiveness of therapies for anomia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond Percent Correct: Measuring Change in Individual Picture Naming Ability. Walker, GM., Basilakos, A., Fridriksson, J., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05653466

Adaptive Trial Scheduling in Naming Treatment ... Treatment description: For each condition, all treatment procedures will be matched except for the number of treated words and the trial spacing manipulation.

2. reporter.nih.gov reporter.nih.gov/search/BSk5oKO4xUOV1tCixcH5tg/project-details/10366326

Integrating complementary learning principles in aphasia ... We also predict that adaptive trial spacing in Study 2 will successfully train many more words than is possible in current standard care. In addition, data ...

3. withpower.com withpower.com/trial/phase-aphasia-1-2023-4eb92

Adaptive Naming Treatment Schedules for Aphasia Spacing training sessions (intervening trials) enhances learning outcomes more effectively than massing them together, indicating that both retrieval ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/09602011.2022.2143822

Asynchronous, online spaced-repetition training alleviates ... Overall, online, asynchronous spaced repetition training appears to be effective in treating word-finding difficulties in aphasia.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2589537024000622

Efficacy of a gamified digital therapy for speech production ... iTalkBetter significantly improved naming ability by 13% for trained items compared with no change for untrained items, an average increase of 29 words.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6045968/

An adaptive semantic matching paradigm for reliable and ... The adaptive semantic matching paradigm is a feasible, reliable and valid method for mapping language regions in people with aphasia.

7. clinicaltrial.be clinicaltrial.be/fr/details/175025?per_page=100&recruiting=1&enrolling_by_invitation=0&active_not_recruiting=0&not_yet_recruiting=0&completed=0&only_recruiting=1&only_eligible=0

Adaptive Trial Scheduling in Naming Treatment for Aphasia... Study design: Investigators will enroll 32 people with aphasia in a randomized within-subjects crossover design comparing an adaptive scheduling ...