Multimodal Treatment of Phonological Alexia: Behavioral & fMRI Outcomes

November 28, 2017 updated by: VA Office of Research and Development
This study offers 90-120 hours of 1:1 training to improve reading skills in adults who have poor reading skills following a stroke. Specifically, this study is designed to improve skill in sounding out words for reading and spelling. The overall time commitment for participation in this study is approximately 11-30 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The proposed study is a mixed-effects (single-subject ABA repeated-probe and small group elements) design with 90-120 hours of a modified multi-modal treatment of alexia replicated across up to 18 adults with post-stroke phonological alexia. The short-term goals of this research proposal includes the following: 1) determine if a modified multimodal treatment of phonological alexia can improve pseudoword reading skills (providing a basis from which training will also treat real word reading skills), 2) determine if a modified multimodal treatment of phonological alexia can improve real word reading skills, 3) determine how brain lesion extent and location relate to participants' response to treatment, and 4) identify relationships between changes in functional brain activity in specified regions of interest and participants' response to treatment.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32608
        • North Florida/South Georgia Veterans Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults with post-stroke reading difficulties (phonological alexia)
  • >3 months post-stroke
  • native English speaker
  • can go in MRI scanner (3 to 6 scans),
  • participate in 90 to 120 free treatment sessions
  • return for 3-month post-treatment follow-up assessment & MRI.

Exclusion Criteria:

  • mental illness
  • degenerative disease, visual or auditory acuity impairment
  • drug abuse
  • English is not first language
  • claustrophobia
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Arm 1
Repeated probes every 8 hours of treatment (1/week)
Behavioral: One-on-one treatment of reading difficulties
Multimodal behavioral treatment focused on retraining sound to letter associations and skills in sounding out words when reading. Treatment has been pilot-tested in published papers since 1998.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Real World Reading Skills
Time Frame: Language testing are conducted two weeks prior to treatment, immediately following end of treatment and 3 months after end of treatment.
Real World Reading Skills was tested using the Woodcock Reading Mastery Test-Revised
Language testing are conducted two weeks prior to treatment, immediately following end of treatment and 3 months after end of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Timothy W. Conway, PhD, North Florida/South Georgia Veterans Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

January 20, 2009

First Submitted That Met QC Criteria

January 21, 2009

First Posted (ESTIMATE)

January 22, 2009

Study Record Updates

Last Update Posted (ACTUAL)

November 30, 2017

Last Update Submitted That Met QC Criteria

November 28, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B6699-W

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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