Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02046941
Recruitment Status : Completed
First Posted : January 28, 2014
Results First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Aphasia Stroke Behavioral: Speech Production Treatment Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Brain Biomarkers of Response to Treatment for Apraxia of Speech
Actual Study Start Date : March 1, 2014
Actual Primary Completion Date : January 8, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Speech Production Treatment
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.
Behavioral: Speech Production Treatment
This treatment employs a response-contingent hierarchy made up of verbal modeling/repetition, graphic cueing, integral stimulation, and articulatory placement instruction.




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Percentage Change in Fractional Anisotropy (FA) [ Time Frame: 8 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02046941


Locations
Layout table for location information
United States, California
VA Northern California Health Care System, Mather, CA
Sacramento, California, United States, 95655
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Layout table for investigator information
Principal Investigator: Juliana V. Baldo, PhD VA Northern California Health Care System, Mather, CA
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Study Protocol  [PDF] January 9, 2014
Statistical Analysis Plan  [PDF] January 9, 2014


Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02046941     History of Changes
Other Study ID Numbers: C1532-I
First Posted: January 28, 2014    Key Record Dates
Results First Posted: August 28, 2019
Last Update Posted: August 28, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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
Keywords provided by VA Office of Research and Development:
aphasia
stroke
Magnetic Resonance Imaging
Diffusion Magnetic Resonance Imaging
Additional relevant MeSH terms:
Layout table for MeSH terms
Aphasia
Apraxias
Nervous System Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Psychomotor Disorders