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Clinical Trials/NCT02046941
NCT02046941
Completed
Not Applicable

Brain Biomarkers of Response to Treatment for Apraxia of Speech

VA Office of Research and Development1 site in 1 country17 target enrollmentMarch 1, 2014
ConditionsAphasiaStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aphasia
Sponsor
VA Office of Research and Development
Enrollment
17
Locations
1
Primary Endpoint
Change From Baseline in Percent of Trained Items Correctly Repeated
Status
Completed
Last Updated
6 years ago

Overview

Brief 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.

Detailed Description

The goals of the current study are to identify grey and white matter regions that are predictive of speech treatment response and measure neural plasticity in response to speech treatment, using state-of-the-art neuroimaging and statistical processing techniques in a group of well-characterized left hemisphere patients meeting strict inclusionary criteria. Specifically, the investigators will use voxel-based lesion symptom mapping to identify lesion sites most predictive of a positive response to speech treatment and advanced diffusion imaging techniques to map changes in the integrity of white matter tracts from pre- to post-treatment.

Registry
clinicaltrials.gov
Start Date
March 1, 2014
End Date
June 30, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Change From Baseline in Percent of Trained Items Correctly Repeated

Time Frame: 8 weeks

For each participant, three target sounds were chosen: single consonants, vowels, or clusters at the word level. Based on these target sounds, 10 word items were generated for each target sound that served as Trained Items. Participants were tested on lists of Trained Items (probe trials) during repeated sessions in pre-intervention stage to establish baseline performance (percent of each word list repeated correctly) and during every other treatment session (again, percent of each word list repeated correctly). The change in percent correct list repetition from pre-intervention (5 probe trials) to the end of intervention (final 3 probe trials) was calculated as individual treatment effect sizes using the Busk \& Serlin (1992) d2 statistic, which involves subtracting the difference between mean performance at end of the intervention minus pre-intervention, divided by the pooled standard deviation of the two phases. The larger the d2 effect size, the larger the effect of the treatment.

Change From Baseline in Percent of Untrained Items Correctly Repeated

Time Frame: 8 weeks

To test generalization, we assessed the change in performance (percent correct repetition) on lists of 10 Untrained Items that had the same speech production targets as each patient's lists of 10 Trained Items, balanced for syllabic structure, word frequency, grammatical form class, and stress pattern. Just as for Trained Items, participants were tested on the lists of Untrained Items (probe trials) during repeated sessions in the pre-intervention stage to establish baseline performance and during every other treatment session (percent of each word list repeated correctly). The change in percent correct list repetition from pre-intervention (5 probe trials) to end of intervention (final 3 probe trials) was calculated as individual treatment effect sizes using the d2 statistic: the difference between mean performance at end of the intervention minus pre-intervention, divided by the pooled standard deviation. The larger the d2 effect size, the larger the effect of the treatment.

Secondary Outcomes

  • Percentage Change in Fractional Anisotropy (FA)(8 weeks)

Study Sites (1)

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