Multimodal Treatment of Phonological Alexia: Behavioral & fMRI Outcomes

NCT ID: NCT00827268

Last Updated: 2017-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Aphasia Stroke Dyslexia, Acquired

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a repeated probe design study.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Repeated probes every 8 hours of treatment (1/week)

Group Type OTHER

One-on-one treatment of reading difficulties

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy W. Conway, PhD

Role: PRINCIPAL_INVESTIGATOR

North Florida/South Georgia Veterans Health System

Locations

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North Florida/South Georgia Veterans Health System

Gainesville, Florida, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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B6699-W

Identifier Type: -

Identifier Source: org_study_id

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