Enhancing Language Function in Aphasia

NCT05443633 | Recruiting

• 1 other identifier: STUDY00001134
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Aphasia, Acquired; Language Disorders; Primary Progressive Aphasia; Stroke, Cerebrovascular

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Active therapy group

EXPERIMENTAL

Participants will undergo individualized language treatment in which they will learn semantically- or phonologically based strategies to facilitate word finding difficulties, sentence formulation difficulties, 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.

Behavioral: individualized speech-language training

control group

ACTIVE COMPARATOR

control group will undergo standard speech-language intervention

Behavioral: standard language intervention

Interventions

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).

Also known as: active

Active therapy group

standard language intervention BEHAVIORAL

Participants will undergo standard speech-language naming therapy

Also known as: control

control group

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85721-0071, United States

RECRUITING

MeSH Terms

Conditions

Aphasia; Language Disorders; Aphasia, Primary Progressive; Stroke

Interventions

Exercise

Condition Hierarchy (Ancestors)

Speech Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dementia; Brain Diseases; Central Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Aneta Kielar, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aneta Kielar, PhD

CONTACT

15204883791; akielar@email.arizona.edu

Fatima Jebahi, MS

CONTACT

fjebahi@email.arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The subject codes will be used for blinding of the participants, care-providers, and assessors
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: individuals will be randomized to the active intervention or control group (standard care)

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 5, 2022
• Study Start: October 30, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 15, 2028
• Last Updated: December 9, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)