Clinical trial NCT05443633: Enhancing Language Function in Aphasia
Official title: Enhancing Language Function in Aphasia Using Behavioral Language Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aphasia, Acquired
Language Disorders
Primary Progressive Aphasia
Stroke, Cerebrovascular
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: individuals will be randomized to the active intervention or control group (standard care)
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Individuals diagnosed with mood, anxiety, psychotic or substance abuse disorders.
2. Individuals with highly magnetizable metallic implants, including certain dental work, may be excluded due to image quality in MRI.
3. Individuals with other neurological disorders besides the ones of interest for the study (e.g., epilepsy, Multiple Sclerosis, Parkinson's Disease)
4. 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.
5. Individuals suffering from clinically significant claustrophobia
6. Severe systemic disease (e.g., renal failure)
7. Poor overall health
8. Individuals who are pregnant
9. Individuals with a history of epileptic activity in the past 12 months
10. Individuals with a personal or family history of epilepsy or other seizure disorders will not be included in the study.
11. Individuals who have had a brain surgery in the past
12. Individuals with implanted metallic skull plates or intracranial implants
13. Individuals with skin lesions or skull damage
14. Individuals who have a history of excessive use of alcohol or drugs
15. Individuals with premorbid psychiatric disease affecting communication
16. Individuals with severe non-linguistic cognitive disturbances impeding language therapy

Primary outcomes:
measure: Mean change from baseline scores on the naming task
timeFrame: through study completion, an average of 1 year
measure: Mean change from baseline scores in aphasia severity
timeFrame: through study completion, an average of 1 year
measure: Mean change from baseline scores on the language probe task before and after each session
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Aneta Kielar, PhD
role: PRINCIPAL_INVESTIGATOR
References: