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Overcoming Learned Non-Use in Chronic Aphasia

Primary Purpose

Stroke-induced Aphasia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intensive Language Action Therapy
Sponsored by
University of Massachusetts, Amherst
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke-induced Aphasia focused on measuring aphasia, anomia, speech therapy, rehabilitation, neuroplasticity, fMRI, quality of life

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • unilateral left hemisphere stroke at least 6 months earlier
  • aphasia with moderate-to-severe word retrieval impairments
  • at least 21 years of age
  • premorbidly right handed
  • native speaker of English

Exclusion Criteria:

  • history of developmental learning difficulties
  • history of prior neurological illnesses
  • chronic medical illnesses that restrict participation in intensive therapy
  • recent alcohol or drug dependence
  • severe uncorrected impairments of vision or hearing
  • any contraindication to a 3T MRI procedure (e.g., claustrophobia, metal implants or fragments in body, pregnancy)

Sites / Locations

  • University of Massachusetts Amherst

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intensive Language Action Therapy ("constrained")

Unconstrained Intensive Language Action Therapy

Arm Description

Following a phase of baseline pre-treatment testing, speech therapy sessions take place 5 days/week for 3 hours per session during two consecutive weeks. Spoken responses are explicitly modeled and encouraged during therapy. Following the intensive 2-week treatment, participants are trained in using individualized home practice programs on iPads. They practice approximately daily for six months, checking in weekly with an SLP via videoconferencing software and return for probes monthly. Six months post-treatment testing will take place following completion of the home practice phase and again at 12 months post-treatment.

Following a phase of baseline pre-treatment testing, speech therapy sessions take place 5 days/week for 3 hours per session during two consecutive weeks. All communicative responses are encouraged during therapy. Following the intensive 2-week treatment, participants are trained in using individualized home practice programs on iPads. They practice approximately daily for six months, checking in weekly with an SLP via videoconferencing software and return for probes monthly. Six months post-treatment testing will take place following completion of the home practice phase and again at 12 months post-treatment.

Outcomes

Primary Outcome Measures

• Change from baseline on Confrontation Naming Task

Secondary Outcome Measures

Change from baseline Boston Diagnostic Aphasia Examination

Full Information

First Posted
February 12, 2013
Last Updated
December 19, 2022
Sponsor
University of Massachusetts, Amherst
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT02012374
Brief Title
Overcoming Learned Non-Use in Chronic Aphasia
Official Title
Overcoming Learned Non-Use in Chronic Aphasia: Behavioral, fMRI and QoL Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 26, 2012 (Actual)
Primary Completion Date
March 17, 2015 (Actual)
Study Completion Date
July 9, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Massachusetts, Amherst
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this study the investigators are examining the effectiveness of intensive speech therapy in chronic moderate-to-severe stroke-induced aphasia under two conditions - responses "constrained" or unconstrained to speech. Both treatments involve massed practice communicating, using intensive language action therapy 3 hours/day, 5 days/week for two weeks, followed by six months of a home practice program. One treatment stresses spoken responses as the preferred expressive modality during intensive therapy. Before and after treatment, and following the home practice program and a period of no practice, the investigators will administer several tests and discourse samples to examine changes associated with the treatments. Participants will also undergo structural and functional MRI testing at these time points. The investigators will also attempt to quantify the degree to which improvements following intensive language therapy and home practice correlate with changes in Quality of Life measures as perceived by both participants with aphasia and their significant others. It is hypothesized that, whereas both treatments will lead to improvements in naming practiced words and communicating, outcomes will be enhanced for the group randomly assigned to the "constraint" condition. Moreover, performance will be enhanced on words practiced during the home practice program, including those that were not practiced during intensive therapy. Improved naming will correlate with modulation of 'signature' language and attentional networks, whose variability will depend on remaining viable brain structures. Initial severity and site/extent of lesion should predict patients' ability to transfer gains in naming to improvements in discourse.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke-induced Aphasia
Keywords
aphasia, anomia, speech therapy, rehabilitation, neuroplasticity, fMRI, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensive Language Action Therapy ("constrained")
Arm Type
Experimental
Arm Description
Following a phase of baseline pre-treatment testing, speech therapy sessions take place 5 days/week for 3 hours per session during two consecutive weeks. Spoken responses are explicitly modeled and encouraged during therapy. Following the intensive 2-week treatment, participants are trained in using individualized home practice programs on iPads. They practice approximately daily for six months, checking in weekly with an SLP via videoconferencing software and return for probes monthly. Six months post-treatment testing will take place following completion of the home practice phase and again at 12 months post-treatment.
Arm Title
Unconstrained Intensive Language Action Therapy
Arm Type
Experimental
Arm Description
Following a phase of baseline pre-treatment testing, speech therapy sessions take place 5 days/week for 3 hours per session during two consecutive weeks. All communicative responses are encouraged during therapy. Following the intensive 2-week treatment, participants are trained in using individualized home practice programs on iPads. They practice approximately daily for six months, checking in weekly with an SLP via videoconferencing software and return for probes monthly. Six months post-treatment testing will take place following completion of the home practice phase and again at 12 months post-treatment.
Intervention Type
Behavioral
Intervention Name(s)
Intensive Language Action Therapy
Primary Outcome Measure Information:
Title
• Change from baseline on Confrontation Naming Task
Time Frame
Change will be assessed immediately post-treatment (2 weeks)
Secondary Outcome Measure Information:
Title
Change from baseline Boston Diagnostic Aphasia Examination
Time Frame
Change will be assessed immediately post-treatment (2 weeks)
Other Pre-specified Outcome Measures:
Title
Change from baseline Boston Naming Test
Time Frame
Change will be assessed immediately post-treatment (2 weeks)
Title
Change from baseline discourse samples
Time Frame
Change will be assessed post-home practice program (approx. 6 months)
Title
Change from baseline Assessment of Living with Aphasia
Time Frame
Change will be assessed post-home practice program (approx. 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: unilateral left hemisphere stroke at least 6 months earlier aphasia with moderate-to-severe word retrieval impairments at least 21 years of age premorbidly right handed native speaker of English Exclusion Criteria: history of developmental learning difficulties history of prior neurological illnesses chronic medical illnesses that restrict participation in intensive therapy recent alcohol or drug dependence severe uncorrected impairments of vision or hearing any contraindication to a 3T MRI procedure (e.g., claustrophobia, metal implants or fragments in body, pregnancy)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacquie Kurland, Ph.D.
Organizational Affiliation
UMass Amherst
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts Amherst
City
Amherst
State/Province
Massachusetts
ZIP/Postal Code
01003
Country
United States

12. IPD Sharing Statement

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Overcoming Learned Non-Use in Chronic Aphasia

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