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
Last Update Posted : August 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Aphasia Stroke||Behavioral: Speech Production Treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 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|
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.
- Percent change in naming score for trained and untrained items [ Time Frame: 8 weeks ]For each participant, three target sounds will be chosen, and these may be single consonants, vowels, or clusters at the word level. Twenty items for each speech sound will be developed: 10 which will serve as Trained items and 10 which will serve as untrained items. The trained and untrained items will be balanced according to syllabic structure, word frequency, grammatical form class, and stress pattern. The trained items will allow us to measure acquisition effects, and the untrained items will allow us to measure generalization effects of SPT.
- Change in fractional anisotropy [ Time Frame: 8 weeks ]To measure neuroplasticity associated with the speech treatment protocol, the investigators will calculate the difference in fractional anisotropy values from pre- to post-treatment for each of the eight fiber tracts in the left hemisphere.
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
|United States, California|
|VA Northern California Health Care System, Mather, CA|
|Sacramento, California, United States, 95655|
|Principal Investigator:||Juliana V. Baldo, PhD||VA Northern California Health Care System, Mather, CA|