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

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 Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	The Center for the Neurobiology of Language Recovery (CNLR)

Resource links provided by NLM:

MedlinePlus related topics: Aphasia

U.S. FDA Resources

Further study details as provided by Cynthia K Thompson, Northwestern University:

Primary Outcome Measures:

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).

Secondary Outcome Measures:

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
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.
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


Enrollment:	83
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 (Adult, Senior)
Sexes Eligible for Study:	All
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

Locations


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

More Information

Additional Information:

Northwestern University's Aphasia and Neurolinguistics Research Laboratory This link exits the ClinicalTrials.gov site

Boston University's Aphasia Research Laboratory This link exits the ClinicalTrials.gov site

Johns Hopkins University's CogNeuro Research Laboratory This link exits the ClinicalTrials.gov site


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 ( U.S. NIH Grant/Contract )
Study First Received:	July 29, 2013
Last Updated:	August 31, 2017

Keywords provided by Cynthia K Thompson, Northwestern University:


Aphasia Dysgraphia Anomia Agrammatism	Stroke Language Recovery Treatment Biomarkers of Recovery

Additional relevant MeSH terms:


Speech Disorders Aphasia Anomia Agraphia Aphasia, Broca Language Disorders	Communication Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms

ClinicalTrials.gov processed this record on September 21, 2017