Trial record 16 of 59 for:    Open Studies | "Aphasia"

Overcoming Learned Non-Use in Chronic Aphasia

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Massachusetts, Amherst
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Massachusetts, Amherst
ClinicalTrials.gov Identifier:
NCT02012374
First received: February 12, 2013
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Stroke-induced Aphasia
Behavioral: Intensive Language Action Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Overcoming Learned Non-Use in Chronic Aphasia: Behavioral, fMRI and QoL Outcomes

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Amherst:

Primary Outcome Measures:
  • • Change from baseline on Confrontation Naming Task [ Time Frame: Change will be assessed immediately post-treatment (2 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline Boston Diagnostic Aphasia Examination [ Time Frame: Change will be assessed immediately post-treatment (2 weeks) ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change from baseline Boston Naming Test [ Time Frame: Change will be assessed immediately post-treatment (2 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline discourse samples [ Time Frame: Change will be assessed post-home practice program (approx. 6 months) ] [ Designated as safety issue: No ]
  • Change from baseline Assessment of Living with Aphasia [ Time Frame: Change will be assessed post-home practice program (approx. 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: March 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02012374

Contacts
Contact: Jacquie Kurland, Ph.D. (413) 545-4007 jkurland@comdis.umass.edu
Contact: Polly Stokes, M.S. (413) 545-4008 pestokes@comdis.umass.edu

Locations
United States, Massachusetts
University of Massachusetts Amherst Recruiting
Amherst, Massachusetts, United States, 01003
Contact: Jacquie Kurland, Ph.D.    413-545-4007    jkurland@comdis.umass.edu   
Contact: Polly Stokes, M.S.    (413) 545-4008    pestokes@comdis.umass.edu   
Principal Investigator: Jacquie Kurland, Ph.D.         
Sponsors and Collaborators
University of Massachusetts, Amherst
Investigators
Principal Investigator: Jacquie Kurland, Ph.D. UMass Amherst
  More Information

No publications provided

Responsible Party: University of Massachusetts, Amherst
ClinicalTrials.gov Identifier: NCT02012374     History of Changes
Other Study ID Numbers: 2011-1065
Study First Received: February 12, 2013
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Massachusetts, Amherst:
aphasia
anomia
speech therapy
rehabilitation
neuroplasticity
fMRI
quality of life

Additional relevant MeSH terms:
Aphasia
Stroke
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014