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Completed

NCT Number: NCT02012374

Overcoming Learned Non-Use in Chronic Aphasia

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.

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Key information

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts Amherst

Amherst, Massachusetts, 01003, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Intensive Language Action Therapy

Behavioral

Primary outcomes

  1. • Change from baseline on Confrontation Naming Task

    Time frame: Change will be assessed immediately post-treatment (2 weeks)

Secondary outcomes

  1. Change from baseline Boston Diagnostic Aphasia Examination

    Time frame: Change will be assessed immediately post-treatment (2 weeks)

Other outcomes

  1. Change from baseline Boston Naming Test

    Time frame: Change will be assessed immediately post-treatment (2 weeks)

  2. Change from baseline discourse samples

    Time frame: Change will be assessed post-home practice program (approx. 6 months)

  3. Change from baseline Assessment of Living with Aphasia

    Time frame: Change will be assessed post-home practice program (approx. 6 months

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Amherst

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 16, 2013
Registry last updated
Dec 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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