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

August 9, 2021 updated by: Cynthia K Thompson, Northwestern University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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: No Treatment
No treatment will be administered.
Behavioral: Treatment Focusing on Improving Spelling Abilities
Treatment will be administered from week 0 until week 12.
Other Names:
  • Language 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.
Behavioral: No Treatment
No treatment will be administered.
Behavioral: Treatment Focusing on Improving Sentence Processing
Treatment will be administered from week 0 until week 12.
Other Names:
  • Language Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
week 0 to week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
week 0 to week 12
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.
week 12 to week 24
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
week 12 to week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

National Institutes of Health (NIH)
National Institute on Deafness and Other Communication Disorders (NIDCD)

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Actual)

March 27, 2019

Study Completion (Actual)

March 27, 2019

Study Registration Dates

First Submitted

July 29, 2013

First Submitted That Met QC Criteria

August 19, 2013

First Posted (Estimate)

August 22, 2013

Study Record Updates

Last Update Posted (Actual)

August 11, 2021

Last Update Submitted That Met QC Criteria

August 9, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P50
  • P50DC012283 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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