Neurobiology of Language Recovery in Aphasia: Natural History and Treatment-Induced Recovery

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purpose of this study is to investigate the effects of treatment for specific language deficits in people with aphasia. In addition to language and cognitive measures, changes in brain function will also be gathered before and after the treatment is administered in order to track any changes resulting from receiving treatment.

Condition or disease	Intervention/treatment	Phase
Aphasia; Dysgraphia; Anomia; Agrammatism; Stroke	Behavioral: Treatment Focusing on Naming Objects; Behavioral: Treatment Focusing on Improving Spelling Abilities; Behavioral: Treatment Focusing on Improving Sentence Processing; Behavioral: No Treatment	Not Applicable

Detailed Description:

Naming Impairments (Anomia):

The labs of Dr. Swathi Kiran (Boston University) and Dr. David Caplan (Harvard University, Massachusetts General Hospital) will be studying language recovery in adults with anomia (naming impairments) following a stroke. Participants will receive treatment focusing on the semantic features of common objects (e.g., that birds can fly). The study will examine how naming and other language abilities change in response to treatment, as well as how the brain changes, as measured by magnetic resonance imaging (MRI) and other techniques.

Spelling/Writing Impairments (Dysgraphia):

At Johns Hopkins University, the lab of Dr. Brenda Rapp will investigate the neurobiology of language recovery in individuals with dysgraphia (spelling/writing impairments) resulting from a stroke. In this study, treatment will focus on improving spelling ability. The study will examine how spelling and other language abilities change in response to treatment, as well as how the brain changes, as measured by magnetic resonance imaging (MRI) and other techniques.

Deficits in Sentence Comprehension & Production:

Dr. Cynthia Thompson's lab at Northwestern University will investigate language recovery in individuals with deficits in sentence production and comprehension. Treatment focuses on production and comprehension of complex sentences. At baseline (week 0) and after the treatment period (at week 12), participants take part in language, eye-tracking, and MRI testing, in order to learn how the processing of language, as well as brain function, changes as a result of treatment.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	90 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	The Center for the Neurobiology of Language Recovery (CNLR)
Study Start Date :	April 2013
Estimated Primary Completion Date :	March 2018
Estimated Study Completion Date :	March 2019

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Naming Deficits; Language treatment will focus on improving naming deficits in people who have aphasia. An experimental group will receive treatment focusing on naming objects and a control/natural history group will receive no treatment. Both groups will be assessed at baseline (week 0), at week 12, and at week 24.	Behavioral: Treatment Focusing on Naming Objects; Treatment will be administered from week 0 until week 12.; Other Name: Language treatment Behavioral: No Treatment; No treatment will be administered.
Experimental: Spelling and/or Writing Deficits; Language treatment will focus on improving writing and/or spelling deficits in people who have aphasia. An experimental group will receive treatment focusing on improving spelling abilities and a control/natural history group will receive no treatment. Both groups will be assessed at baseline (week 0), at week 12, and at week 24.	Behavioral: Treatment Focusing on Improving Spelling Abilities; Treatment will be administered from week 0 until week 12.; Other Name: Language Treatment Behavioral: No Treatment; No treatment will be administered.
Experimental: Sentence Processing; Language treatment will focus on improving sentence comprehension and production deficits in people who have aphasia. An experimental group will receive treatment focusing on improving sentence processing and a control/natural history group will receive no treatment. Both groups will be assessed at baseline (week 0), at week 12, and at week 24.	Behavioral: Treatment Focusing on Improving Sentence Processing; Treatment will be administered from week 0 until week 12.; Other Name: Language Treatment Behavioral: No Treatment; No treatment will be administered.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Change in language and cognitive abilities as a result of treatment [ Time Frame: week 0 to week 12 ]
   Standard and non-standard measures of language and cognitive abilities will be gathered at baseline (week 0) to see if language deficits improve after treatment is administered (week 12).

Secondary Outcome Measures :

1. Composite change in brain function as a result of treatment [ Time Frame: week 0 to week 12 ]

   Neural correlates of treatment effects will be examined using:

   • Functional Magnetic Resonance Imaging (fMRI)
   • Diffusion Tensor Imaging (DTI)
   • Perfusion Imaging
   • Functional Connectivity
   • Rest state Connectivity
2. Maintenance of language and cognitive abilities as a result of treatment [ Time Frame: week 12 to week 24 ]
   Standard and non-standard measures of language and cognitive abilities administered at week 12 will be compared to those administered at week 24 to see if improvement in language abilities as a result of treatment is maintained.
3. Maintenance of composite changes in brain function as a result of treatment [ Time Frame: week 12 to week 24 ]

   Neural correlates of treatment effects that are maintained for 12 weeks after treatment ends (week 12 to week 24) will be examined using:

   • Functional Magnetic Resonance Imaging (fMRI)
   • Diffusion Tensor Imaging (DTI)
   • Perfusion Imaging
   • Functional Connectivity
   • Rest state Connectivity

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	35 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Aphasia following a stroke
• Stoke was at least 1 year ago
• Medically stable
• Right-handed
• Normal or 'corrected to normal' vision and hearing
• English as primary language
• At least a high school education

Exclusion Criteria:

• History of neurological disease, head trauma, psychiatric disorders, alcoholism, or developmental speech, language, or learning disabilities

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60208
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21218
United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02215
Harvard University
Cambridge, Massachusetts, United States, 02138

Sponsors and Collaborators

Northwestern University

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institutes of Health (NIH)

Investigators

Study Director:	Cynthia K Thompson, PhD	Northwestern University
Principal Investigator:	David Caplan, MDCM, PhD	Harvard University, Massachusetts General Hospital
Principal Investigator:	Brenda Rapp, PhD	Johns Hopkins University
Principal Investigator:	Swathi Kiran, PhD, CCC-SLP	Boston University
Principal Investigator:	Todd B Parrish, PhD	Northwestern University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Northwestern University's Aphasia and Neurolinguistics Research Laboratory 

Boston University's Aphasia Research Laboratory 

Responsible Party:	Cynthia K Thompson, Ralph and Jean Sundin Professor of Communication Sciences, Northwestern University
ClinicalTrials.gov Identifier:	NCT01927302 History of Changes
Other Study ID Numbers:	P50; P50DC012283 ( U.S. NIH Grant/Contract )
First Posted:	August 22, 2013
Last Update Posted:	December 15, 2017
Last Verified:	December 2017

Keywords provided by Cynthia K Thompson, Northwestern University:

Aphasia; Dysgraphia; Anomia; Agrammatism	Stroke; Language Recovery; Treatment; Biomarkers of Recovery

Additional relevant MeSH terms:

Speech Disorders; Aphasia; Anomia; Agraphia; Aphasia, Broca; Language Disorders	Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms