Enhancing Language Function in Aphasia

Primary Progressive Aphasia Clinical Trial

Official title:

Enhancing Language Function in Aphasia Using Behavioral Language Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05443633
• Other study ID #: STUDY00001134
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2022
• Est. completion date: December 15, 2028

Study information

• Verified date: September 2023
• Source: University of Arizona
• Contact: Aneta Kielar, PhD
• Phone: 15204883791
• Email: akielar[@]email.arizona.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 15, 2028
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Aphasia, Acquired
• Aphasia, Primary Progressive
• Frontotemporal Dementia
• Language Disorders
• Pick Disease of the Brain
• Primary Progressive Aphasia
• Stroke

Intervention

Behavioral:
• individualized speech-language training
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).
• standard language intervention
Participants will undergo standard speech-language naming therapy

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline scores on the naming task	Mean change from baseline scores on the Boston Naming Test: Min score = 0; Max = 60; higher scores indicate better outcome	through study completion, an average of 1 year
Primary	Mean change from baseline scores in aphasia severity	Mean change from baseline scores on the Western Aphasia Battery: Min score = 0; Max = 100; higher scores indicate better outcome	through study completion, an average of 1 year
Primary	Mean change from baseline scores on the language probe task before and after each session	change on on the probe task from before the session; Min =0; Max = 100%; higher scores indicate better outcome	through study completion, an average of 1 year