Back to resultsEnhancing Language Function in Aphasia
Primary Purpose
Aphasia, Acquired, Language Disorders, Primary Progressive Aphasia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
individualized speech-language training
standard language intervention
Sponsored by
About this trial
This is an interventional treatment trial for Aphasia, Acquired
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.
- 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
- Individuals with severe non-linguistic cognitive disturbances impeding language therapy
Sites / Locations
- University of ArizonaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Active therapy group
control group
Arm Description
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.
control group will undergo standard speech-language intervention
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05443633
Brief Title
Enhancing Language Function in Aphasia
Official Title
Enhancing Language Function in Aphasia Using Behavioral Language Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 30, 2022 (Actual)
Primary Completion Date
June 30, 2027 (Anticipated)
Study Completion Date
December 15, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Acquired, Language Disorders, Primary Progressive Aphasia, Stroke, Cerebrovascular
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
individuals will be randomized to the active intervention or control group (standard care)
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
The subject codes will be used for blinding of the participants, care-providers, and assessors
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active therapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
control group will undergo standard speech-language intervention
Intervention Type
Behavioral
Intervention Name(s)
individualized speech-language training
Other Intervention Name(s)
active
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
standard language intervention
Other Intervention Name(s)
control
Intervention Description
Participants will undergo standard speech-language naming therapy
Primary Outcome Measure Information:
Title
Mean change from baseline scores on the naming task
Description
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
Title
Mean change from baseline scores in aphasia severity
Description
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
Title
Mean change from baseline scores on the language probe task before and after each session
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
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
Individuals with severe non-linguistic cognitive disturbances impeding language therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aneta Kielar, PhD
Phone
15204883791
Email
akielar@email.arizona.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Fatima Jebahi, MS
Email
fjebahi@email.arizona.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aneta Kielar, PhD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85721-0071
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aneta Kielar, PHD
Phone
520-488-3791
Email
akielar@email.arizona.edu
First Name & Middle Initial & Last Name & Degree
Fatima Jebahi, MS
Email
fjebahi@email.arizona.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Enhancing Language Function in Aphasia
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