Overcoming Learned Non-Use in Chronic Aphasia

Overcoming Learned Non-Use in Chronic Aphasia: Behavioral, fMRI and QoL Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Stroke-induced Aphasia
• Intervention / Treatment: Behavioral: Intensive Language Action Therapy

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Amherst, Massachusetts, United States, 01003
      • University of Massachusetts Amherst

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensive Language Action Therapy ("constrained"); 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.	Behavioral: Intensive Language Action Therapy
Experimental: Unconstrained Intensive Language Action Therapy; 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.	Behavioral: Intensive Language Action Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
• Change from baseline on Confrontation Naming Task	Change will be assessed immediately post-treatment (2 weeks)

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline Boston Diagnostic Aphasia Examination	Change will be assessed immediately post-treatment (2 weeks)

Other Outcome Measures

Outcome Measure	Time Frame
Change from baseline Boston Naming Test	Change will be assessed immediately post-treatment (2 weeks)
Change from baseline discourse samples	Change will be assessed post-home practice program (approx. 6 months)
Change from baseline Assessment of Living with Aphasia	Change will be assessed post-home practice program (approx. 6 months

Collaborators and Investigators

• Sponsor: University of Massachusetts, Amherst
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Jacquie Kurland, Ph.D., UMass Amherst

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2012
• Primary Completion (Actual): March 17, 2015
• Study Completion (Actual): July 9, 2015

Study Registration Dates

• First Submitted: February 12, 2013
• First Submitted That Met QC Criteria: December 9, 2013
• First Posted (Estimate): December 16, 2013

Study Record Updates

• Last Update Posted (Estimate): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: rehabilitation; quality of life; fMRI; neuroplasticity; speech therapy; aphasia; anomia
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Aphasia
• Other Study ID Numbers: 2011-1065