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Clinical Trials/NCT05443633
NCT05443633
Recruiting
N/A

Enhancing Language Function in Aphasia Using Behavioral Language Intervention

University of Arizona1 site in 1 country30 target enrollmentOctober 30, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Aphasia, Acquired
Sponsor
University of Arizona
Enrollment
30
Locations
1
Primary Endpoint
Mean change from baseline scores on the naming task
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 30, 2022
End Date
December 15, 2028
Last Updated
last year
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

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

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 Sites (1)

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