Overview

This trial is active, not recruiting.

Condition stroke-induced aphasia
Treatment intensive language action therapy
Sponsor University of Massachusetts, Amherst
Collaborator National Institute on Deafness and Other Communication Disorders (NIDCD)
Start date March 2012
End date August 2015
Trial size 24 participants
Trial identifier NCT02012374, 2011-1065

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
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.
intensive language action therapy
(Experimental)
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.
intensive language action therapy

Primary Outcomes

Measure
• Change from baseline on Confrontation Naming Task
time frame: Change will be assessed immediately post-treatment (2 weeks)

Secondary Outcomes

Measure
Change from baseline Boston Diagnostic Aphasia Examination
time frame: Change will be assessed immediately post-treatment (2 weeks)

Eligibility Criteria

Male or female participants from 21 years up to 90 years old.

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)

Additional Information

Official title Overcoming Learned Non-Use in Chronic Aphasia: Behavioral, fMRI and QoL Outcomes
Principal investigator Jacquie Kurland, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Massachusetts, Amherst.