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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Northwestern University
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Cynthia K Thompson, Northwestern University
ClinicalTrials.gov Identifier:
NCT01927302
First received: July 29, 2013
Last updated: June 3, 2014
Last verified: June 2014

July 29, 2013
June 3, 2014
April 2013
March 2018   (final data collection date for primary outcome measure)
Change in language and cognitive abilities as a result of treatment [ Time Frame: week 0 to week 12 ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01927302 on ClinicalTrials.gov Archive Site
  • Composite change in brain function as a result of treatment [ Time Frame: week 0 to week 12 ] [ Designated as safety issue: No ]

    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
  • Maintenance of language and cognitive abilities as a result of treatment [ Time Frame: week 12 to week 24 ] [ Designated as safety issue: No ]
    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.
  • Maintenance of composite changes in brain function as a result of treatment [ Time Frame: week 12 to week 24 ] [ Designated as safety issue: No ]

    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
Same as current
Not Provided
Not Provided
 
Neurobiology of Language Recovery in Aphasia: Natural History and Treatment-Induced Recovery
The Center for the Neurobiology of Language Recovery (CNLR)

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Aphasia
  • Dysgraphia
  • Anomia
  • Agrammatism
  • Stroke
  • Behavioral: Treatment Focusing on Naming Objects
    Treatment will be administered from week 0 until week 12.
    Other Name: Language treatment
  • Behavioral: Treatment Focusing on Improving Spelling Abilities
    Treatment will be administered from week 0 until week 12.
    Other Name: Language Treatment
  • 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.
  • 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.
    Interventions:
    • Behavioral: Treatment Focusing on Naming Objects
    • Behavioral: No Treatment
  • 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.
    Interventions:
    • Behavioral: Treatment Focusing on Improving Spelling Abilities
    • Behavioral: No Treatment
  • 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.
    Interventions:
    • Behavioral: Treatment Focusing on Improving Sentence Processing
    • Behavioral: No Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
March 2019
March 2018   (final data collection date for primary outcome measure)

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
Both
35 Years to 80 Years
No
Contact: Brianne M Dougherty, B.S. (847) 467 - 7591 CNLR@northwestern.edu
Contact: Mary Cosic (847) 491 - 2469 m-cosic@northwestern.edu
United States
 
NCT01927302
P50, P50DC012283
No
Cynthia K Thompson, Northwestern University
Northwestern University
  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • National Institutes of Health (NIH)
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
Northwestern University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP