We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified July 2017 by VA Office of Research and Development
Sponsor:
ClinicalTrials.gov Identifier:
NCT02046941
First Posted: January 28, 2014
Last Update Posted: July 26, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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 Intervention
Aphasia Stroke Behavioral: Speech Production Treatment

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 44
Actual Study Start Date: March 1, 2014
Estimated Study Completion Date: March 1, 2018
Estimated Primary Completion Date: January 8, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

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.


Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
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
  Contacts and Locations
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


Contacts
Contact: Jeanette R Rainey, BS (916) 843-7195 Jeanette.Rainey@va.gov
Contact: Jary Larsen (916) 366-5333

Locations
United States, California
VA Northern California Health Care System, Mather, CA Recruiting
Sacramento, California, United States, 95655
Contact: Jeanette R Rainey, BS    916-843-7195    Jeanette.Rainey@va.gov   
Principal Investigator: Juliana V. Baldo, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Juliana V. Baldo, PhD VA Northern California Health Care System, Mather, CA
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02046941     History of Changes
Other Study ID Numbers: C1532-I
First Submitted: January 24, 2014
First Posted: January 28, 2014
Last Update Posted: July 26, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Aphasia
Apraxias
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Psychomotor Disorders