N/A
N=17
Brain Biomarkers of Response to Treatment for Apraxia of Speech
Aphasia · Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02046941 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Change From Baseline in Percent of Trained Items Correctly Repeated — 6.67 d2 treatment effect size
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Speech Production Treatment (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Percent of Trained Items Correctly Repeated |
6.67 | — |
| PRIMARY Change From Baseline in Percent of Untrained Items Correctly Repeated |
2.66 | — |
| SECONDARY Percentage Change in Fractional Anisotropy (FA) |
-0.46 | — |
Summary
The study will use MRI brain imaging to identify brain changes associated in stroke patients after they receive speech-language treatment for their speech difficulties.
Eligibility Criteria
Inclusion Criteria
- Inclusion criteria are age 40-90
- primary English speaker since < age 5
- a history of a single left hemisphere stroke
- at least 1 year post-stroke
- at least 12 years of education
- pre-morbidly right-handed (Edinburgh Handedness Questionnaire)
- within normal limits on the Test of Non-Verbal Intelligence
Exclusion Criteria
- Exclusion criteria will include a pre-morbid neurologic or psychiatric history
- history/current substance abuse disorder
- MRI contraindications
- other motor speech disorders (e.g., dysarthria)
- current or recent (<2 months) speech/language therapy
- prior SPT
- pre-morbid history of speech/language disorders
- significant hearing disabilities (based on a pure-tone audiological screen at 35 dB HL at 500, 1K, and 2K Hz for at least one ear)
- aphasia severity resulting in <30th percentile performance on the Porch Index of Communicative Ability-R
Data sourced from ClinicalTrials.gov (NCT02046941). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.