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RecruitingNCT05443633Updated Dec 9, 2024

Enhancing Language Function in Aphasia

An interventional study of individualized speech-language training and standard language intervention in Aphasia, Acquired, Language Disorders and Primary Progressive Aphasia, sponsored by University of Arizona. Recruiting at 1 site in United States. Open to participants aged 21 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-09.

Sponsored by University of Arizona · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2022; still recruiting 3 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
21 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Aphasia, Acquired
  • Language Disorders
  • Primary Progressive Aphasia
  • Stroke, Cerebrovascular
03

In context

Aphasia

372 studies on the registry are indexed under Aphasia; 90 are open to participants now.

This study's planned enrollment of 30 is close to the median of 30 across 322 interventional studies indexed under Aphasia.

Browse Aphasia studies →

Lead sponsor

University of Arizona is the lead sponsor of 475 studies on the registry; 87 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 30 (59%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Active therapy group

    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

  • Active comparator
    control group

    control group will undergo standard speech-language intervention

    Behavioral: standard language intervention

Interventions

  • Behavioralindividualized 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).

    Also known as: active

  • Behavioralstandard language intervention

    Participants will undergo standard speech-language naming therapy

    Also known as: control

06

What researchers measure

Primary outcomes

  1. 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

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

  2. 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

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

  3. 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

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2022 (actual). Primary completion is estimated for Jun 2027, 56 months after the start.

Of 197 non-industry interventional studies with no phase under Aphasia, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 54. This study's planned 56 months is above that.

Counting every sponsor, half of 200 studies reached it within 36 months; a quarter within 19 and three quarters within 54.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 29, 2022
First posted
Jul 5, 2022
StartActual
Oct 30, 2022
Primary completionEst.
Jun 30, 2027
CompletionEst.
Dec 15, 2028
Last update
Dec 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05443633
Responsible party
Sponsor
First posted
Jul 5, 2022
Start date
Oct 30, 2022
Primary completion
Jun 30, 2027 (estimated)
Completion
Dec 15, 2028 (estimated)
Last update
Dec 9, 2024

Study contacts

Aneta Kielar, PhD
Contact
akielar@email.arizona.edu
15204883791
Fatima Jebahi, MS
Contact
fjebahi@email.arizona.edu
Aneta Kielar, PhD
principal investigator · University of Arizona

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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