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

Primary Purpose

Aphasia, Dysgraphia, Anomia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment Focusing on Naming Objects
Treatment Focusing on Improving Spelling Abilities
Treatment Focusing on Improving Sentence Processing
No Treatment
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia focused on measuring Aphasia, Dysgraphia, Anomia, Agrammatism, Stroke, Language Recovery, Treatment, Biomarkers of Recovery

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern University
  • Johns Hopkins University
  • Boston University
  • Harvard University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Naming Deficits

Spelling and/or Writing Deficits

Sentence Processing

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in language and cognitive abilities as a result of treatment
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
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
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
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

Full Information

First Posted
July 29, 2013
Last Updated
August 9, 2021
Sponsor
Northwestern University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01927302
Brief Title
Neurobiology of Language Recovery in Aphasia: Natural History and Treatment-Induced Recovery
Official Title
The Center for the Neurobiology of Language Recovery (CNLR)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
March 27, 2019 (Actual)
Study Completion Date
March 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Dysgraphia, Anomia, Agrammatism, Stroke
Keywords
Aphasia, Dysgraphia, Anomia, Agrammatism, Stroke, Language Recovery, Treatment, Biomarkers of Recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Naming Deficits
Arm Type
Experimental
Arm Description
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.
Arm Title
Spelling and/or Writing Deficits
Arm Type
Experimental
Arm Description
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.
Arm Title
Sentence Processing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment Focusing on Naming Objects
Other Intervention Name(s)
Language treatment
Intervention Description
Treatment will be administered from week 0 until week 12.
Intervention Type
Behavioral
Intervention Name(s)
Treatment Focusing on Improving Spelling Abilities
Other Intervention Name(s)
Language Treatment
Intervention Description
Treatment will be administered from week 0 until week 12.
Intervention Type
Behavioral
Intervention Name(s)
Treatment Focusing on Improving Sentence Processing
Other Intervention Name(s)
Language Treatment
Intervention Description
Treatment will be administered from week 0 until week 12.
Intervention Type
Behavioral
Intervention Name(s)
No Treatment
Intervention Description
No treatment will be administered.
Primary Outcome Measure Information:
Title
Change in language and cognitive abilities as a result of treatment
Description
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).
Time Frame
week 0 to week 12
Secondary Outcome Measure Information:
Title
Composite change in brain function as a result of treatment
Description
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
Time Frame
week 0 to week 12
Title
Maintenance of language and cognitive abilities as a result of treatment
Description
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.
Time Frame
week 12 to week 24
Title
Maintenance of composite changes in brain function as a result of treatment
Description
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
Time Frame
week 12 to week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia K Thompson, PhD
Organizational Affiliation
Northwestern University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David Caplan, MDCM, PhD
Organizational Affiliation
Harvard University Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brenda Rapp, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Swathi Kiran, PhD, CCC-SLP
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Todd B Parrish, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Harvard University
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States

12. IPD Sharing Statement

Citations:
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31419597
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Barbieri E, Mack J, Chiappetta B, Europa E, Thompson CK. Recovery of offline and online sentence processing in aphasia: Language and domain-general network neuroplasticity. Cortex. 2019 Nov;120:394-418. doi: 10.1016/j.cortex.2019.06.015. Epub 2019 Jul 13.
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28357141
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Thompson CK, Walenski M, Chen Y, Caplan D, Kiran S, Rapp B, Grunewald K, Nunez M, Zinbarg R, Parrish TB. Intrahemispheric Perfusion in Chronic Stroke-Induced Aphasia. Neural Plast. 2017;2017:2361691. doi: 10.1155/2017/2361691. Epub 2017 Mar 5.
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Lukic S, Barbieri E, Wang X, Caplan D, Kiran S, Rapp B, Parrish TB, Thompson CK. Right Hemisphere Grey Matter Volume and Language Functions in Stroke Aphasia. Neural Plast. 2017;2017:5601509. doi: 10.1155/2017/5601509. Epub 2017 May 9.
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Lukic S, Thompson CK, Barbieri E, Chiappetta B, Bonakdarpour B, Kiran S, Rapp B, Parrish TB, Caplan D. Common and distinct neural substrates of sentence production and comprehension. Neuroimage. 2021 Jan 1;224:117374. doi: 10.1016/j.neuroimage.2020.117374. Epub 2020 Sep 17.
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Higgins J, Barbieri E, Wang X, Mack J, Caplan D, Kiran S, Rapp B, Thompson C, Zinbarg R, Parrish T. Reliability of BOLD signals in chronic stroke-induced aphasia. Eur J Neurosci. 2020 Oct;52(8):3963-3978. doi: 10.1111/ejn.14739. Epub 2020 Apr 28.
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Europa E, Gitelman DR, Kiran S, Thompson CK. Neural Connectivity in Syntactic Movement Processing. Front Hum Neurosci. 2019 Feb 13;13:27. doi: 10.3389/fnhum.2019.00027. eCollection 2019.
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PubMed Identifier
31103888
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Lukic S, Meltzer-Asscher A, Higgins J, Parrish TB, Thompson CK. Neurocognitive correlates of category ambiguous verb processing: The single versus dual lexical entry hypotheses. Brain Lang. 2019 Jul;194:65-76. doi: 10.1016/j.bandl.2019.04.005. Epub 2019 May 16.
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Hsu CJ, Thompson CK. Manual Versus Automated Narrative Analysis of Agrammatic Production Patterns: The Northwestern Narrative Language Analysis and Computerized Language Analysis. J Speech Lang Hear Res. 2018 Feb 15;61(2):373-385. doi: 10.1044/2017_JSLHR-L-17-0185.
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Thompson CK. Single subject controlled experiments in aphasia: the science and the state of the science. J Commun Disord. 2006 Jul-Aug;39(4):266-91. doi: 10.1016/j.jcomdis.2006.02.003. Epub 2006 Apr 25.
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24961525
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Mack JE, Meltzer-Asscher A, Barbieri E, Thompson CK. Neural correlates of processing passive sentences. Brain Sci. 2013 Aug 2;3(3):1198-214. doi: 10.3390/brainsci3031198.
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25658635
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Meltzer-Asscher A, Mack JE, Barbieri E, Thompson CK. How the brain processes different dimensions of argument structure complexity: evidence from fMRI. Brain Lang. 2015 Mar;142:65-75. doi: 10.1016/j.bandl.2014.12.005. Epub 2015 Feb 4.
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Schuchard J, Nerantzini M, Thompson CK. Implicit learning and implicit treatment outcomes in individuals with aphasia. Aphasiology. 2017;31(1):25-48. doi: 10.1080/02687038.2016.1147526. Epub 2016 Feb 19.
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Mack JE, Wei AZ, Gutierrez S, Thompson CK. Tracking sentence comprehension: Test-retest reliability in people with aphasia and unimpaired adults. J Neurolinguistics. 2016 Nov;40:98-111. doi: 10.1016/j.jneuroling.2016.06.001. Epub 2016 Jun 24.
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28690782
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Schuchard J, Thompson CK. Sequential learning in individuals with agrammatic aphasia: evidence from artificial grammar learning. J Cogn Psychol (Hove). 2017;29(5):521-534. doi: 10.1080/20445911.2017.1293065. Epub 2017 Feb 17.
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Johnson JP, Meier EL, Pan Y, Kiran S. Treatment-related changes in neural activation vary according to treatment response and extent of spared tissue in patients with chronic aphasia. Cortex. 2019 Dec;121:147-168. doi: 10.1016/j.cortex.2019.08.016. Epub 2019 Sep 19.
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Links:
URL
http://www.bu.edu/aphasiaresearch/
Description
Boston University's Aphasia Research Laboratory
URL
http://sites.krieger.jhu.edu/cogneuro-lab/
Description
Johns Hopkins University's CogNeuro Research Laboratory

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

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