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NCT Number: NCT05443633

Enhancing Language Function in Aphasia

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.

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Key information

Conditions

Aphasia, Acquired Aphasia Aphasia, Primary Progressive Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Communication Disorders Dementia Language Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Primary Progressive Aphasia Signs and Symptoms Speech Disorders Stroke Stroke, Cerebrovascular Vascular Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The purpose of this study is to develop semantic-based treatment to address language deficits in individuals with acquired language disorders. We propose to develop an individually optimized semantic-based protocol for strategy implementation and word finding facilitation among individuals with language disorders.

Phase 1: Following screening, participants who fulfill the inclusion criteria and have consented to participate in the study will undergo baseline cognitive and language assessment, electroencephalography (EEG) recording and the magnetic resonance imaging (MRI) scan. Participants with language disorders will proceed to the following phases.

Phase 2: After baseline assessment, participants will undergo individualized language treatment in which they will learn semantically- or phonologically based strategies to facilitate word finding difficulties, sentence formulation, 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.

Phase 3: Directly following treatment, patients will undergo cognitive and language assessment, EEG recording, and an MRI scan. This is done to test for short-term changes in behavioral abilities and neural patterns.

Phase 4: After 2 months after the treatment, participants will undergo cognitive and language assessment, EEG recording, and an MRI scan. This final phase of testing is done to test for long-term changes in behavioral abilities and neural responses.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Present with speech-language impairment (aphasia) caused by stroke or dementia
  • A medical diagnosis of primary progressive aphasia (PPA) by a neurologist or physician
  • Are native speakers of English
  • Present with no contraindications for MRI
  • Have adequate (normal or corrected to normal) vision and hearing

Exclusion criteria

  • Individuals diagnosed with mood, anxiety, psychotic or substance abuse disorders.
  • Individuals with highly magnetizable metallic implants, including certain dental work, may be excluded due to image quality in MRI.
  • Individuals with other neurological disorders besides the ones of interest for the study (e.g., epilepsy, Multiple Sclerosis, Parkinson's Disease)
  • Individuals with contraindications for MRI. This includes but is not limited to pacemakers, metallic cardiac pumps, valves, magnetic materials such as surgical clips, implanted electronic perfusion pumps, or any other condition that would preclude proximity to a strong magnetic field.
  • Individuals suffering from clinically significant claustrophobia
  • Severe systemic disease (e.g., renal failure)
  • Poor overall health
  • Individuals who are pregnant
  • Individuals with a history of epileptic activity in the past 12 months
  • Individuals with a personal or family history of epilepsy or other seizure disorders will not be included in the study.
  • Individuals who have had a brain surgery in the past
  • Individuals with implanted metallic skull plates or intracranial implants
  • Individuals with skin lesions or skull damage
  • Individuals who have a history of excessive use of alcohol or drugs
  • Individuals with premorbid psychiatric disease affecting communication
  • Individuals with severe non-linguistic cognitive disturbances impeding language therapy

Treatment and study plan

individualized speech-language training

Behavioral

Language treatment might include lexical, semantic, and interactive treatment. During treatment, patients may be trained to name words by attempting to self-cue lexical retrieval. The therapy moves incrementally through semantic cuing. The semantic treatment will be implemented using the methods described in (Edmonds et al., 2009, 2014).

Other names: active

standard language intervention

Behavioral

Participants will undergo standard speech-language naming therapy

Other names: control

Primary outcomes

  1. Mean change from baseline scores on the naming task

    Time frame: through study completion, an average of 1 year

    Mean change from baseline scores on the Boston Naming Test: Min score = 0; Max = 60; higher scores indicate better outcome

  2. Mean change from baseline scores in aphasia severity

    Time frame: through study completion, an average of 1 year

    Mean change from baseline scores on the Western Aphasia Battery: Min score = 0; Max = 100; higher scores indicate better outcome

  3. Mean change from baseline scores on the language probe task before and after each session

    Time frame: through study completion, an average of 1 year

    change on on the probe task from before the session; Min =0; Max = 100%; higher scores indicate better outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Aneta Kielar, PhD

CONTACT

[email protected]

15204883791

Fatima Jebahi, MS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

Enhancing Language Function in Aphasia Using Behavioral Language Intervention

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Jul 5, 2022
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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