Visual Feedback Training for Aphasia

Recruiting at 2 trial locations

Overseen By Roozbeh Behroozmand, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas at Dallas

Disqualifiers: Hearing, Memory, Cognitive, Laryngeal, 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: Unknown

Duration: 2 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

Aphasia is the most common type of post-stroke communication disorder characterized by deficits in speech comprehension, production and control. While recovery can be promoted with speech therapy, improvement remains modest and typically requires a large number of sessions contributing to rising health care costs. Traditional aphasia therapy focus on enhancing speech motor output; however, recent evidence suggests that the auditory feedback also plays a critical role in fluent speech. Therefore, a key step toward refining treatment strategies is to develop objective biomarkers that can probe the integrity of sensorimotor mechanisms of speech auditory feedback and identify their impaired function in patients with post-stroke aphasia. This study aims to examine the behavioral, neurophysiological (EEG), and neuroimaging (fMRI) biomarkers of speech impairment following stroke with focus on understanding the role of auditory feedback for speech production and control. We plan to test individuals with post-stroke aphasia and a matched neuroptypical control group during different speech production tasks under the altered auditory feedback paradigm. In addition, we aim to examine the effect of audio-visual feedback training on enhancing communication ability during speech. These biomarkers will be combined with existing lesion-symptom-mapping data in the aphasic group in order to identify the patterns of brain damage and diminished structural connectivity within the auditory-motor areas of the left hemisphere that predict impaired sensorimotor processing of speech in aphasia. The long-term goal of this research is to develop a model for identifying the source of sensorimotor deficit and improve diagnosis and targeted treatment of speech disorders in aphasia.

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 data supports the effectiveness of the treatment Visual Feedback Training for aphasia?

Research shows that therapies involving visual and action-based feedback, like Visual Action Therapy and action observation therapy, can significantly improve communication skills in people with aphasia. These approaches help patients use gestures and observe actions, which enhances their language recovery. ^{1 2 3 4 5}

Is Visual Feedback Training generally safe for humans?

Research on visual feedback in speech therapy, including ultrasound visual feedback, suggests it is generally safe, with no significant undesired effects reported by participants. ^{6 7 8 9 10}

How is Visual Feedback Training for Aphasia different from other treatments?

Visual Feedback Training for Aphasia is unique because it uses visual cues to help patients improve their speech by showing them how to adjust their tongue and mouth movements, which is different from traditional speech therapies that may not use visual aids. ^{1 6 10 11 12}

Eligibility Criteria

This trial is for English-speaking adults aged 21-75 who have aphasia after a stroke, can perform the study tasks, and have no severe hearing or cognitive issues. Healthy controls with normal speech and no neurological disorders are also needed. Both groups must be right-handed.

Inclusion Criteria

I have speech difficulties but can still do the required tasks.

I am between 21 and 75 years old.

I have never had a neurological or psychiatric disorder.

Exclusion Criteria

You have conditions that make it unsafe for you to have an EEG or MRI scan.

I have had issues with my voice box, like weakness or paralysis.

I have moderate to severe issues with hearing, memory, or thinking.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo speech production tasks under altered auditory feedback and audio-visual feedback training

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Visual Feedback Training

Trial Overview The study tests how visual feedback training affects speech in people with aphasia by using EEG and fMRI to track brain activity during speech tasks under altered auditory conditions. It aims to improve communication abilities and develop targeted treatments.

Participant Groups

Group I: Control Group Experimental Treatment 1 Intervention

Group II: Aphasia Group Experimental Treatment 1 Intervention

Visual Feedback Training is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Visual Feedback Training for:

• Post-stroke aphasia
• Speech comprehension deficits
• Speech production impairments

Approved in United States as Audio-Visual Feedback Training for:

• Aphasia
• Speech disorders
• Communication impairments

Approved in Canada as Speech Therapy with Visual Feedback for:

• Post-stroke communication disorders
• Speech production deficits
• Auditory feedback impairments

Who Is Running the Clinical Trial?

The University of Texas at Dallas

Lead Sponsor

Trials

71

Recruited

108,000+

University of South Carolina

Lead Sponsor

Trials

233

Recruited

122,000+

Findings from Research

In a study involving eight globally aphasic patients who did not respond to traditional treatments, Visual Action Therapy (VAT) led to significant improvements in their ability to produce symbolic gestures and understand auditory information.

Statistical analyses of pre and post-treatment scores on the Porch Index of Communicative Ability (PICA) showed marked enhancements in pantomimic and auditory comprehension skills, suggesting VAT is an effective nonvocal intervention for improving communication in aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visual action therapy for global aphasia. Helm-Estabrooks, N., Fitzpatrick, PM., Barresi, B.[2019]

Speech and language therapy for individuals with aphasia after a stroke has been shown to lead to significant improvements in various domains of functioning, including impairment, activity, participation, and well-being, based on a study of 1664 patients.

The results from this large group of patients align with findings from randomized control trials, reinforcing the effectiveness of speech and language therapy in rehabilitation for aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Where are we now with aphasia after Stroke? Enderby, P., Sutton, L.[2022]

A study involving 17 patients with chronic nonfluent aphasia showed that virtual reality-based therapy using the Rehabilitation Gaming System significantly improved language and communication skills compared to standard treatment, particularly in the experimental group.

Both groups improved in vocabulary retention after treatment, but only the virtual reality group demonstrated lasting improvements in overall language and communication skills at the 16-week follow-up, highlighting the potential of technology-enhanced rehabilitation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmented Dyadic Therapy Boosts Recovery of Language Function in Patients With Nonfluent Aphasia. Grechuta, K., Rubio Ballester, B., Espín Munne, R., et al.[2020]

The Lexi study aims to evaluate whether the Neolexon® app, used alongside standard speech therapy, is more effective in treating acute post-stroke aphasia than standard therapy alone, involving 180 patients over a 4-week treatment period.

The primary outcome will measure the difference in aphasia severity using the Bielefelder Aphasie Screening (BIAS), with a follow-up after 3 months to assess overall effectiveness and quality of life improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Follow-Up in Aphasia Caused by Acute Stroke in a Prospective, Randomized, Clinical, and Experimental Controlled Noninvasive Study With an iPad-Based App (Neolexon®): Study Protocol of the Lexi Study. Thunstedt, DC., Young, P., Küpper, C., et al.[2020]

Non-invasive neurostimulation techniques have shown promising results in improving word-retrieval deficits in chronic stroke patients with aphasia, suggesting a new avenue for rehabilitation.

Action observation therapy, which involves observing or executing gestures, has been found to positively influence language recovery, particularly for action-related words, indicating its potential as an effective treatment for aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Options to enhance recovery from aphasia by means of non-invasive brain stimulation and action observation therapy. Marangolo, P., Caltagirone, C.[2014]

In a pilot study involving 9 patients with Parkinson's disease and dysarthria, augmented visual feedback significantly improved the size of articulatory movements during speaking tasks, with 8 out of 9 participants showing increased movement amplitude after training.

The majority of participants were able to retain the learned skill 48 hours after training, indicating that this method could be a feasible approach for enhancing speech in individuals with hypokinetic dysarthria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Game-Based Augmented Visual Feedback for Enlarging Speech Movements in Parkinson's Disease. Yunusova, Y., Kearney, E., Kulkarni, M., et al.[2019]

In a study involving 62 participants aged around 12 years, the majority reported no concerns about using ultrasound visual feedback in speech therapy, indicating a generally positive reception of the treatment.

The most common undesired effects reported were related to the ultrasound gel (40%) and probe positioning (21%), but these were considered minor and should be balanced against the potential benefits of the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do Participants Report Any Undesired Effects in Ultrasound Speech Therapy? Preston, JL., Holliman-Lopez, G., Leece, MC.[2023]

In a study involving 30 older adults, visual-verbal and verbal-quantitative feedback methods significantly improved their ability to match different speaking rates compared to verbal-qualitative feedback.

The findings suggest that using more precise feedback methods can enhance performance in tasks like speech rate matching, which could be beneficial for training individuals with speech disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of three feedback modes on the ability of normal geriatric individuals to match speaking rate. Hyland, JD., Weismer, G.[2019]

In two studies involving 6 adults with apraxia of speech (AOS), reduced-frequency or delayed feedback during speech skill training improved learning outcomes for some participants, suggesting a beneficial approach to treatment.

The results indicate that while structured interventions can help individuals with AOS, the effectiveness of feedback strategies may be influenced by other factors like the complexity of the speech tasks, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of feedback frequency and timing on acquisition, retention, and transfer of speech skills in acquired apraxia of speech. Austermann Hula, SN., Robin, DA., Maas, E., et al.[2022]

In a study involving 20 participants (10 with aphasia/apraxia of speech and 10 neurologically healthy), 7 out of 10 individuals with speech disorders showed improved fluency when using masked auditory feedback (MAF), suggesting that this method can help some people with speech difficulties.

In contrast, the control condition of altered auditory feedback (AAF) did not lead to improvements in fluency for most participants, indicating that MAF may specifically address issues related to auditory feedback monitoring in speech disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory Masking Effects on Speech Fluency in Apraxia of Speech and Aphasia: Comparison to Altered Auditory Feedback. Jacks, A., Haley, KL.[2018]

A 1-month study using electromagnetic articulography showed that visually guided biofeedback on tongue-tip position significantly improved articulation in an adult with Broca's aphasia and apraxia of speech, particularly for nonspeech oral tasks.

In contrast, a foil treatment using voicing-contrast stimuli resulted in only marginal improvements, indicating that visual biofeedback may be a more effective intervention for addressing articulation deficits in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electromagnetic articulography treatment for an adult with Broca's aphasia and apraxia of speech. Katz, WF., Bharadwaj, SV., Carstens, B.[2019]

Visual feedback significantly improved the production of /s/ sounds in six patients with cleft palate, particularly for those with abnormal tongue positioning, as assessed by objective measures.

The study utilized the Rion Electropalatograph and a multi-function speech training aid to provide visual feedback, demonstrating the effectiveness of these tools in speech therapy for cleft palate patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of visual feedback treatment for defective /s/ sounds in patients with cleft palate. Michi, K., Yamashita, Y., Imai, S., et al.[2019]

References

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

Visual action therapy for global aphasia. [2019]

2. India pubmed.ncbi.nlm.nih.gov

Where are we now with aphasia after Stroke? [2022]

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

Augmented Dyadic Therapy Boosts Recovery of Language Function in Patients With Nonfluent Aphasia. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Follow-Up in Aphasia Caused by Acute Stroke in a Prospective, Randomized, Clinical, and Experimental Controlled Noninvasive Study With an iPad-Based App (Neolexon®): Study Protocol of the Lexi Study. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Options to enhance recovery from aphasia by means of non-invasive brain stimulation and action observation therapy. [2014]

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

Game-Based Augmented Visual Feedback for Enlarging Speech Movements in Parkinson's Disease. [2019]

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

Do Participants Report Any Undesired Effects in Ultrasound Speech Therapy? [2023]

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

The effects of three feedback modes on the ability of normal geriatric individuals to match speaking rate. [2019]

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

Effects of feedback frequency and timing on acquisition, retention, and transfer of speech skills in acquired apraxia of speech. [2022]

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

Auditory Masking Effects on Speech Fluency in Apraxia of Speech and Aphasia: Comparison to Altered Auditory Feedback. [2018]

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

Electromagnetic articulography treatment for an adult with Broca's aphasia and apraxia of speech. [2019]

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

Role of visual feedback treatment for defective /s/ sounds in patients with cleft palate. [2019]