Clinical trial NCT01927302: 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
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Dysgraphia
Anomia
Agrammatism
Stroke
Keywords: Aphasia
Dysgraphia
Anomia
Agrammatism
Stroke
Language Recovery
Treatment
Biomarkers of Recovery
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: National Institutes of Health (NIH)
First posted: 2013-08-22
Enrollment: 90
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in language and cognitive abilities as a result of treatment
timeFrame: week 0 to week 12
Secondary outcomes:
measure: Composite change in brain function as a result of treatment
timeFrame: week 0 to week 12
measure: Maintenance of language and cognitive abilities as a result of treatment
timeFrame: week 12 to week 24
measure: Maintenance of composite changes in brain function as a result of treatment
timeFrame: week 12 to week 24
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Boston University
state: Massachusetts
city: Cambridge
country: United States
facility: Harvard University
state: Massachusetts
Study officials:
affiliation: Northwestern University
name: Cynthia K Thompson, PhD
role: STUDY_DIRECTOR
affiliation: Harvard University Massachusetts General Hospital
name: David Caplan, MDCM, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Brenda Rapp, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston University
name: Swathi Kiran, PhD, CCC-SLP
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Todd B Parrish, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walenski M, Europa E, Caplan D, Thompson CK. Neural networks for sentence comprehension and production: An ALE-based meta-analysis of neuroimaging studies. Hum Brain Mapp. 2019 Jun 1;40(8):2275-2304. doi: 10.1002/hbm.24523. Epub 2019 Jan 28.
citation: Kiran S, Thompson CK. Neuroplasticity of Language Networks in Aphasia: Advances, Updates, and Future Challenges. Front Neurol. 2019 Apr 2;10:295. doi: 10.3389/fneur.2019.00295. eCollection 2019.
citation: Crinion J, Holland AL, Copland DA, Thompson CK, Hillis AE. Neuroimaging in aphasia treatment research: quantifying brain lesions after stroke. Neuroimage. 2013 Jun;73:208-14. doi: 10.1016/j.neuroimage.2012.07.044. Epub 2012 Jul 27.
citation: Kiran S, Ansaldo A, Bastiaanse R, Cherney LR, Howard D, Faroqi-Shah Y, Meinzer M, Thompson CK. Neuroimaging in aphasia treatment research: standards for establishing the effects of treatment. Neuroimage. 2013 Aug 1;76:428-35. doi: 10.1016/j.neuroimage.2012.10.011. Epub 2012 Oct 9.
citation: Meinzer M, Beeson PM, Cappa S, Crinion J, Kiran S, Saur D, Parrish T, Crosson B, Thompson CK; Neuroimaging in Aphasia Treatment Research Workshop. Neuroimaging in aphasia treatment research: consensus and practical guidelines for data analysis. Neuroimage. 2013 Jun;73:215-24. doi: 10.1016/j.neuroimage.2012.02.058. Epub 2012 Feb 24.
citation: Rapp B, Caplan D, Edwards S, Visch-Brink E, Thompson CK. Neuroimaging in aphasia treatment research: issues of experimental design for relating cognitive to neural changes. Neuroimage. 2013 Jun;73:200-7. doi: 10.1016/j.neuroimage.2012.09.007. Epub 2012 Sep 10.
citation: Ditges R, Barbieri E, Thompson CK, Weintraub S, Weiller C, Mesulam MM, Kummerer D, Schroter N, Musso M. German Language Adaptation of the NAVS (NAVS-G) and of the NAT (NAT-G): Testing Grammar in Aphasia. Brain Sci. 2021 Apr 8;11(4):474. doi: 10.3390/brainsci11040474.
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citation: Cho-Reyes S, Mack JE, Thompson CK. Grammatical Encoding and Learning in Agrammatic Aphasia: Evidence from Structural Priming. J Mem Lang. 2016 Dec;91:202-218. doi: 10.1016/j.jml.2016.02.004. Epub 2016 Mar 21.
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citation: Mack JE, Thompson CK. Recovery of Online Sentence Processing in Aphasia: Eye Movement Changes Resulting From Treatment of Underlying Forms. J Speech Lang Hear Res. 2017 May 24;60(5):1299-1315. doi: 10.1044/2016_JSLHR-L-16-0108.
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citation: 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.
citation: 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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citation: 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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citation: 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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citation: 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.