Brain Biomarkers of Response to Treatment for Apraxia of Speech

Stroke Clinical Trial

— SPT  

Official title:

Brain Biomarkers of Response to Treatment for Apraxia of Speech

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02046941
• Other study ID #: C1532-I
• Status: Completed
• Phase: N/A
• Start date: March 1, 2014
• Est. completion date: June 30, 2018

Study information

• Verified date: July 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 30, 2018
• Est. primary completion date: January 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Apraxias
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	VA Northern California Health Care System, Mather, CA	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	8 weeks