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
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Center for the Neurobiology of Language Recovery (CNLR)

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 200
Study Start Date: April 2013
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
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
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: NCT01927302

Contacts
Contact: Brianne M Dougherty, B.S. (847) 467 - 7591 CNLR@northwestern.edu
Contact: Mary Cosic (847) 491 - 2469 m-cosic@northwestern.edu

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60208
Contact: Brianne M Dougherty, B.S.    847-467-7591    brianne.dougherty@northwestern.edu   
Principal Investigator: Cynthia K Thompson, PhD         
Principal Investigator: Todd B Parrish, PhD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21218
Contact: Jennifer Shea    410-516-5250    shea@cogsci.jhu.edu   
Principal Investigator: Brenda Rapp, PhD         
United States, Massachusetts
Boston University Recruiting
Boston, Massachusetts, United States, 02215
Contact: Sarah N Villard, MS, MA    617-353-2706    sarah.n.villard@gmail.com   
Principal Investigator: Swathi Kiran, PhD, CCC-SLP         
Harvard University Recruiting
Cambridge, Massachusetts, United States, 02138
Contact: Jennifer Michaud       jmichaud1@partners.org   
Principal Investigator: David Caplan, MDCM, PhD         
Sponsors and Collaborators
Northwestern University
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

Additional Information:
No publications provided

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
Study First Received: July 29, 2013
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Aphasia
Dysgraphia
Anomia
Agrammatism
Stroke
Language Recovery
Treatment
Biomarkers of Recovery

Additional relevant MeSH terms:
Aphasia
Communication Disorders
Language Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Speech Disorders

ClinicalTrials.gov processed this record on October 29, 2014