Brain Biomarkers of Response to Treatment for Apraxia of Speech

NCT ID: NCT02046941

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-01
• Study Completion Date: 2018-06-30

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.

Conditions

Aphasia; Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Speech Production Treatment

Intervention Type: BEHAVIORAL

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

Interventions

Speech Production Treatment

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juliana V. Baldo, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Northern California Health Care System, Mather, CA

Locations

VA Northern California Health Care System, Mather, CA

Sacramento, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

C1532-I

Identifier Type: -

Identifier Source: org_study_id