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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01927302
Other study ID # P50
Secondary ID P50DC012283
Status Completed
Phase N/A
First received
Last updated
Start date April 2013
Est. completion date March 27, 2019

Study information

Verified date August 2021
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date March 27, 2019
Est. primary completion date March 27, 2019
Accepts healthy volunteers No
Gender All
Age group 35 Years to 80 Years
Eligibility 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 Design


Intervention

Behavioral:
Treatment Focusing on Naming Objects
Treatment will be administered from week 0 until week 12.
Treatment Focusing on Improving Spelling Abilities
Treatment will be administered from week 0 until week 12.
Treatment Focusing on Improving Sentence Processing
Treatment will be administered from week 0 until week 12.
No Treatment
No treatment will be administered.

Locations

Country Name City State
United States Johns Hopkins University Baltimore Maryland
United States Boston University Boston Massachusetts
United States Harvard University Cambridge Massachusetts
United States Northwestern University Chicago Illinois

Sponsors (3)

Lead Sponsor Collaborator
Northwestern University National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (71)

Alpert K, Kogan A, Parrish T, Marcus D, Wang L. The Northwestern University Neuroimaging Data Archive (NUNDA). Neuroimage. 2016 Jan 1;124(Pt B):1131-1136. doi: 10.1016/j.neuroimage.2015.05.060. Epub 2015 May 30. — View Citation

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. — View Citation

Breining B, Nozari N, Rapp B. Does segmental overlap help or hurt? Evidence from blocked cyclic naming in spoken and written production. Psychon Bull Rev. 2016 Apr;23(2):500-6. doi: 10.3758/s13423-015-0900-x. — View Citation

Breining B, Rapp B. Investigating the mechanisms of written word production: Insights from the written blocked cyclic naming paradigm. Read Writ. 2019 Jan;32(1):65-94. doi: 10.1007/s11145-017-9742-4. Epub 2017 Apr 12. — View 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. — View 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. Review. — View Citation

Ditges R, Barbieri E, Thompson CK, Weintraub S, Weiller C, Mesulam MM, Kümmerer D, Schröter 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). pii: 474. doi: 10.3390/brainsci11040474. — View Citation

Dufor O, Rapp B. Letter representations in writing: an fMRI adaptation approach. Front Psychol. 2013 Oct 28;4:781. doi: 10.3389/fpsyg.2013.00781. eCollection 2013. — View Citation

Ellenblum G, Purcell JJ, Song X, Rapp B. High-level Integrative Networks: A Resting-state fMRI Investigation of Reading and Spelling. J Cogn Neurosci. 2019 Jul;31(7):961-977. doi: 10.1162/jocn_a_01405. Epub 2019 Apr 2. — View Citation

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. — View Citation

Fischer-Baum S, Rapp B. The analysis of perseverations in acquired dysgraphia reveals the internal structure of orthographic representations. Cogn Neuropsychol. 2014;31(3):237-65. doi: 10.1080/02643294.2014.880676. Epub 2014 Feb 5. — View Citation

Gilmore N, Meier EL, Johnson JP, Kiran S. Nonlinguistic Cognitive Factors Predict Treatment-Induced Recovery in Chronic Poststroke Aphasia. Arch Phys Med Rehabil. 2019 Jul;100(7):1251-1258. doi: 10.1016/j.apmr.2018.12.024. Epub 2019 Jan 9. — View Citation

Gilmore N, Meier EL, Johnson JP, Kiran S. Typicality-based semantic treatment for anomia results in multiple levels of generalisation. Neuropsychol Rehabil. 2020 Jun;30(5):802-828. doi: 10.1080/09602011.2018.1499533. Epub 2018 Jul 20. — View Citation

Hepner C, McCloskey M, Rapp B. Do reading and spelling share orthographic representations? Evidence from developmental dysgraphia. Cogn Neuropsychol. 2017 May - Jun;34(3-4):119-143. doi: 10.1080/02643294.2017.1375904. Epub 2017 Sep 21. — View Citation

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. — View 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- — View Citation

Ingo C, Magin RL, Parrish TB. New Insights into the Fractional Order Diffusion Equation Using Entropy and Kurtosis. Entropy (Basel). 2014 Nov;16(11):5838-5852. doi: 10.3390/e16115838. Epub 2014 Nov 6. — View Citation

Ingo C, Sui Y, Chen Y, Parrish TB, Webb AG, Ronen I. Parsimonious continuous time random walk models and kurtosis for diffusion in magnetic resonance of biological tissue. Front Phys. 2015 Mar;3. pii: 11. doi: 10.3389/fphy.2015.00011. Epub 2015 Mar 16. — View Citation

Iorga M, Higgins J, Caplan D, Zinbarg R, Kiran S, Thompson CK, Rapp B, Parrish TB. Predicting language recovery in post-stroke aphasia using behavior and functional MRI. Sci Rep. 2021 Apr 19;11(1):8419. doi: 10.1038/s41598-021-88022-z. — View 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. Review. — View Citation

Kiran S, Meier EL, Kapse KJ, Glynn PA. Changes in task-based effective connectivity in language networks following rehabilitation in post-stroke patients with aphasia. Front Hum Neurosci. 2015 Jun 9;9:316. doi: 10.3389/fnhum.2015.00316. eCollection 2015. — View 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. Review. — View Citation

Lee J, Yoshida M, Thompson CK. Grammatical Planning Units During Real-Time Sentence Production in Speakers With Agrammatic Aphasia and Healthy Speakers. J Speech Lang Hear Res. 2015 Aug;58(4):1182-94. doi: 10.1044/2015_JSLHR-L-14-0250. Erratum in: J Speech Lang Hear Res. 2015 Dec;58(6):1780. — View 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. — View Citation

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 M — View 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 — View Citation

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. — View Citation

Mack JE, Nerantzini M, Thompson CK. Recovery of Sentence Production Processes Following Language Treatment in Aphasia: Evidence from Eyetracking. Front Hum Neurosci. 2017 Mar 13;11:101. doi: 10.3389/fnhum.2017.00101. eCollection 2017. — View 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. — View 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. Epub 2016 Jun 24. — View Citation

McCloskey M, Rapp B. Developmental dysgraphia: An overview and framework for research. Cogn Neuropsychol. 2017 May - Jun;34(3-4):65-82. doi: 10.1080/02643294.2017.1369016. Epub 2017 Sep 14. — View Citation

Meier EL, Johnson JP, Kiran S. Left frontotemporal effective connectivity during semantic feature judgments in patients with chronic aphasia and age-matched healthy controls. Cortex. 2018 Nov;108:173-192. doi: 10.1016/j.cortex.2018.08.006. Epub 2018 Aug 27. — View Citation

Meier EL, Johnson JP, Pan Y, Kiran S. The utility of lesion classification in predicting language and treatment outcomes in chronic stroke-induced aphasia. Brain Imaging Behav. 2019 Dec;13(6):1510-1525. doi: 10.1007/s11682-019-00118-3. — View Citation

Meier EL, Johnson JP, Villard S, Kiran S. Does Naming Therapy Make Ordering in a Restaurant Easier? Dynamics of Co-Occurring Change in Cognitive-Linguistic and Functional Communication Skills in Aphasia. Am J Speech Lang Pathol. 2017 May 17;26(2):266-280. doi: 10.1044/2016_AJSLP-16-0028. — View Citation

Meier EL, Kapse KJ, Kiran S. The Relationship between Frontotemporal Effective Connectivity during Picture Naming, Behavior, and Preserved Cortical Tissue in Chronic Aphasia. Front Hum Neurosci. 2016 Mar 16;10:109. doi: 10.3389/fnhum.2016.00109. eCollection 2016. — View Citation

Meier EL, Lo M, Kiran S. Understanding semantic and phonological processing deficits in adults with aphasia: Effects of category and typicality. Aphasiology. 2016;30(6):719-749. Epub 2015 Sep 12. — View 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. Review. Erratum in: Neuroimage. 2013 Nov 1;81:507. Neuroimage. 2013 Nov 1;81:507. — View Citation

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. — View Citation

Nickels L, Kohnen S, Rapp B. (Eds.). (2018). Treatment as a tool for investigating cognition. Psychology Press.

Nickels L, Rapp B, Kohnen S. Challenges in the use of treatment to investigate cognition. Cogn Neuropsychol. 2015;32(3-4):91-103. doi: 10.1080/02643294.2015.1056652. — View Citation

Nozari N, Freund M, Breining B, Rapp B, Gordon B. Cognitive control during selection and repair in word production. Lang Cogn Neurosci. 2016;31(7):886-903. doi: 10.1080/23273798.2016.1157194. Epub 2016 Apr 14. — View Citation

Purcell JJ, Rapp B. Identifying functional reorganization of spelling networks: an individual peak probability comparison approach. Front Psychol. 2013 Dec 25;4:964. doi: 10.3389/fpsyg.2013.00964. eCollection 2013. — View Citation

Purcell JJ, Rapp B. Local response heterogeneity indexes experience-based neural differentiation in reading. Neuroimage. 2018 Dec;183:200-211. doi: 10.1016/j.neuroimage.2018.07.063. Epub 2018 Aug 1. — View Citation

Purcell JJ, Shea J, Rapp B. Beyond the visual word form area: the orthography-semantics interface in spelling and reading. Cogn Neuropsychol. 2014;31(5-6):482-510. doi: 10.1080/02643294.2014.909399. Epub 2014 May 16. — View 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. Review. — View Citation

Rapp B, Damian M. (2018). From thought to action: Producing written language. In, Rueschemeyer, S.A & Gaskell, G. (Eds.) Oxford Handbook of Psycholinguistics. Oxford University Press.

Rapp B, Fischer-Baum S, Miozzo M. Modality and morphology: what we write may not be what we say. Psychol Sci. 2015 Jun;26(6):892-902. doi: 10.1177/0956797615573520. Epub 2015 Apr 29. — View Citation

Rapp B, Fischer-Baum S. (2014). Representation of orthographic knowledge. In Ferreira, Goldrick and Miozzo (Eds.) Oxford Handbook on Language Production. Oxford University Press.

Rapp B, Purcell J, Hillis AE, Capasso R, Miceli G. Neural bases of orthographic long-term memory and working memory in dysgraphia. Brain. 2016 Feb;139(Pt 2):588-604. doi: 10.1093/brain/awv348. Epub 2015 Dec 17. — View Citation

Rapp B, Purcell J. (2017). Understanding how we produce written words: Lessons from the brain. In, De Zubicaray, G. and Schiller, N.O. (Eds.) Oxford Handbook of Neurolinguistics. Oxford University Press.

Rapp B, Wiley RW. Re-learning and remembering in the lesioned brain. Neuropsychologia. 2019 Sep;132:107126. doi: 10.1016/j.neuropsychologia.2019.107126. Epub 2019 Jun 19. — View Citation

Riley EA, Thompson CK. Training Pseudoword Reading in Acquired Dyslexia: A Phonological Complexity Approach. Aphasiology. 2015 Feb 1;29(2):129-150. — View Citation

Rothlein D, Rapp B. The role of allograph representations in font-invariant letter identification. J Exp Psychol Hum Percept Perform. 2017 Jul;43(7):1411-1429. doi: 10.1037/xhp0000384. Epub 2017 Apr 3. — View Citation

Rothlein D, Rapp B. The similarity structure of distributed neural responses reveals the multiple representations of letters. Neuroimage. 2014 Apr 1;89:331-44. doi: 10.1016/j.neuroimage.2013.11.054. Epub 2013 Dec 7. — View Citation

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. — View Citation

Schuchard J, Thompson CK. Implicit and explicit learning in individuals with agrammatic aphasia. J Psycholinguist Res. 2014 Jun;43(3):209-24. doi: 10.1007/s10936-013-9248-4. — View Citation

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. — View Citation

Tainturier MJ, Bosse ML, Roberts DJ, Valdois S, Rapp B. Lexical neighborhood effects in pseudoword spelling. Front Psychol. 2013 Nov 28;4:862. doi: 10.3389/fpsyg.2013.00862. eCollection 2013. — View Citation

Tao Y, Rapp B. The effects of lesion and treatment-related recovery on functional network modularity in post-stroke dysgraphia. Neuroimage Clin. 2019;23:101865. doi: 10.1016/j.nicl.2019.101865. Epub 2019 May 22. — View Citation

Thompson CK, Faroqi-Shah Y, & Lee J. (2015). Models of sentence production. In: A. Hillis (Ed.). The handbook of adult language disorders: Integrating cognitive neuropsychology, neurology, and rehabilitation. Second Edition (pp. 328-354). New York: Psychology Press.

Thompson CK, Kielar A. (2014). Neural bases of sentence processing: evidence from neurolinguistic and neuroimaging studies. In M. Goldrick, V. Ferreira, & M. Miozzo (Eds.) The Oxford Handbook of Language Production (pp. 47-69). New York: Oxford University Press.

Thompson CK, Meltzer-Asscher, A. (2014). Neurocognitive mechanisms of verb argument structure processing. In Asaf Bachrach, Isabelle Roy and Linaea Stockall (Eds.) Structuring the Argument: Multidisciplinary research on verb argument structure (pp. 141-168). John Benjamins.

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. — View Citation

Thompson CK. Neurocognitive Recovery of Sentence Processing in Aphasia. J Speech Lang Hear Res. 2019 Nov 22;62(11):3947-3972. doi: 10.1044/2019_JSLHR-L-RSNP-19-0219. Epub 2019 Nov 22. Review. — View Citation

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. Epub 2006 Apr 25. Review. — View Citation

Vallila-Rohter S, Kiran S. (2015). Diagnosis and Treatment of Semantic Impairments. In A. Hillis (Ed.) Handbook on Adult Language Disorders. Taylor & Francis/Psychology Press of 711 Third Avenue, 8th Floor, New York, NY 10017.

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. — View Citation

Wang H, Thompson CK. Assessing Syntactic Deficits in Chinese Broca's aphasia using the Northwestern Assessment of Verbs and Sentences-Chinese (NAVS-C). Aphasiology. 2016;30(7):815-840. Epub 2015 Nov 16. — View Citation

Wang H, Yoshida M, Thompson CK. Parallel functional category deficits in clauses and nominal phrases: The case of English agrammatism. J Neurolinguistics. 2014 Jan;27(1):75-102. — View Citation

Wiley RW, Rapp B. From complexity to distinctiveness: The effect of expertise on letter perception. Psychon Bull Rev. 2019 Jun;26(3):974-984. doi: 10.3758/s13423-018-1550-6. — View Citation

Wiley RW, Wilson C, Rapp B. The effects of alphabet and expertise on letter perception. J Exp Psychol Hum Percept Perform. 2016 Aug;42(8):1186-203. doi: 10.1037/xhp0000213. Epub 2016 Feb 25. — View Citation

* Note: There are 71 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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). week 0 to week 12
Secondary 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
week 0 to week 12
Secondary 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. week 12 to week 24
Secondary 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
week 12 to week 24
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