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Brain Biomarkers of Response to Treatment for Apraxia of Speech (SPT)

Primary Purpose

Aphasia, Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Speech Production Treatment
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Aphasia focused on measuring aphasia, stroke, Magnetic Resonance Imaging, Diffusion Magnetic Resonance Imaging

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Northern California Health Care System, Mather, CA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Speech Production Treatment

Arm Description

This treatment employs a response-contingent hierarchy made up of verbal modeling/repetition, graphic cueing, integral stimulation, and articulatory placement instruction. The investigators chose this treatment for the following reasons: 1) rigor of development demonstrated across multiple studies, 2) large and predictable effects with published, quantified effect sizes, 3) a demonstrated pattern of generalization to untrained items, illustrating experimental control, 4) an established multi-modal stimulation protocol, and 5) use of repeated practice, which is associated with neural plasticity.

Outcomes

Primary Outcome Measures

Change From Baseline in Percent of Trained Items Correctly Repeated
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
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 Outcome Measures

Percentage Change in Fractional Anisotropy (FA)
To measure neuroplasticity associated with the speech treatment protocol, the investigators calculated the percent change in fractional anisotropy (FA) from pre- to post-treatment for each of the eight fiber tracts in the left hemisphere. The average percentage change in FA across all eight fiber tracts was calculated, which could thus range from 0-100%. A positive change indicates an increase in white matter integrity, and a negative change indicates a decrease in white matter integrity. A number close to 0 indicates minimal/no significant change.

Full Information

First Posted
January 24, 2014
Last Updated
July 22, 2019
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02046941
Brief Title
Brain Biomarkers of Response to Treatment for Apraxia of Speech
Acronym
SPT
Official Title
Brain Biomarkers of Response to Treatment for Apraxia of Speech
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2014 (Actual)
Primary Completion Date
January 8, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Stroke
Keywords
aphasia, stroke, Magnetic Resonance Imaging, Diffusion Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Speech Production Treatment
Arm Type
Experimental
Arm Description
This treatment employs a response-contingent hierarchy made up of verbal modeling/repetition, graphic cueing, integral stimulation, and articulatory placement instruction. The investigators chose this treatment for the following reasons: 1) rigor of development demonstrated across multiple studies, 2) large and predictable effects with published, quantified effect sizes, 3) a demonstrated pattern of generalization to untrained items, illustrating experimental control, 4) an established multi-modal stimulation protocol, and 5) use of repeated practice, which is associated with neural plasticity.
Intervention Type
Behavioral
Intervention Name(s)
Speech Production Treatment
Intervention Description
This treatment employs a response-contingent hierarchy made up of verbal modeling/repetition, graphic cueing, integral stimulation, and articulatory placement instruction.
Primary Outcome Measure Information:
Title
Change From Baseline in Percent of Trained Items Correctly Repeated
Description
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.
Time Frame
8 weeks
Title
Change From Baseline in Percent of Untrained Items Correctly Repeated
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Percentage Change in Fractional Anisotropy (FA)
Description
To measure neuroplasticity associated with the speech treatment protocol, the investigators calculated the percent change in fractional anisotropy (FA) from pre- to post-treatment for each of the eight fiber tracts in the left hemisphere. The average percentage change in FA across all eight fiber tracts was calculated, which could thus range from 0-100%. A positive change indicates an increase in white matter integrity, and a negative change indicates a decrease in white matter integrity. A number close to 0 indicates minimal/no significant change.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliana V. Baldo, PhD
Organizational Affiliation
VA Northern California Health Care System, Mather, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Northern California Health Care System, Mather, CA
City
Sacramento
State/Province
California
ZIP/Postal Code
95655
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Brain Biomarkers of Response to Treatment for Apraxia of Speech

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