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

Sponsor

Northwestern University (Other)

Overall Status

Completed

CT.gov ID

NCT01927302

Collaborator

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

Enrollment

Locations

Arms

71.8

Actual Duration (Months)

22.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

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	N/A

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

Study Type:

Interventional

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)

Actual Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Mar 27, 2019

Actual Study Completion Date :

Mar 27, 2019

Arms and Interventions

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: Treatment Focusing on Improving Spelling Abilities Treatment will be administered from week 0 until week 12. Other Names: 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 Names: Language Treatment Behavioral: No Treatment No treatment will be administered.

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: Treatment Focusing on Improving Spelling Abilities

Treatment will be administered from week 0 until week 12.

Other Names:

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 Names:

Language Treatment

Behavioral: No Treatment

No treatment will be administered.

Outcome Measures

Primary Outcome Measures

Change in language and cognitive abilities as a result of treatment [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

Composite change in brain function as a result of treatment [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
Maintenance of language and cognitive abilities as a result of treatment [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.
Maintenance of composite changes in brain function as a result of treatment [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

Criteria

Ages Eligible for Study:

35 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60208
2	Johns Hopkins University	Baltimore	Maryland	United States	21218
3	Boston University	Boston	Massachusetts	United States	02215
4	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