Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2022-10-30
2028-12-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
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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.
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).
control group
control group will undergo standard speech-language intervention
standard language intervention
Participants will undergo standard speech-language naming therapy
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
21 Years
80 Years
ALL
Yes
Sponsors
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University of Arizona
OTHER
Responsible Party
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Principal Investigators
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Aneta Kielar, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Arizona
Locations
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University of Arizona
Tucson, Arizona, United States
Countries
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Central Contacts
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Facility Contacts
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Aneta Kielar, PHD
Role: primary
Fatima Jebahi, MS
Role: backup
Other Identifiers
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STUDY00001134
Identifier Type: -
Identifier Source: org_study_id