Brain Biomarkers of Response to Treatment for Apraxia of Speech

NCT02046941 | Completed Results

• 1 other identifier: C1532-I
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Aphasia; Stroke

Keywords

aphasia; stroke; Magnetic Resonance Imaging; Diffusion Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (2)

• 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.

  8 weeks

• 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.

  8 weeks

Secondary Outcomes (1)

• Percentage Change in Fractional Anisotropy (FA)

  8 weeks

Study Arms (1)

Speech Production Treatment

EXPERIMENTAL

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

Interventions

Speech Production Treatment BEHAVIORAL

This treatment employs a response-contingent hierarchy made up of verbal modeling/repetition, graphic cueing, integral stimulation, and articulatory placement instruction.

Speech Production Treatment

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Northern California Health Care System, Mather, CA

Sacramento, California, 95655, United States

Location

MeSH Terms

Conditions

Aphasia; Stroke

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

The generalizability of the study is limited due to the small sample size. However, published studies using this treatment intervention include even smaller samples (3-4 patients), due to the time-intensive nature of the intervention.

Results Point of Contact

• Title: Juliana Baldo
• Organization: VANCHCS

juliana.baldo@va.gov

925-372-4649

Study Officials

• Juliana V. Baldo, PhD

  VA Northern California Health Care System, Mather, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2014
• First Posted: January 28, 2014
• Study Start: March 1, 2014
• Primary Completion: January 8, 2018
• Study Completion: June 30, 2018
• Last Updated: August 28, 2019
• Results First Posted: August 28, 2019

Record last verified: 2019-07

Locations

US (1)