AphasiaNCT01927302
Neurobiology of Language Recovery in Aphasia: Natural History and Treatment-Induced Recovery
A study testing Treatment Focusing on Naming Objects, Treatment Focusing on Improving Spelling Abilities and Treatment Focusing on Improving Sentence Processing in people with Aphasia and Dysgraphia, run by Northwestern University at 4 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Aphasia, Dysgraphia, Anomia
- What is being tested?
- Treatment Focusing on Naming Objects, Treatment Focusing on Improving Spelling Abilities and Treatment Focusing on Improving Sentence Processing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2013to 27 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of neurological disease, head trauma, psychiatric disorders, alcoholism, or developmental speech, language, or learning disabilities
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins University
Baltimore, Maryland, 21218
Boston University
Boston, Massachusetts, 02215
Harvard University
Cambridge, Massachusetts, 02138
Northwestern University
Chicago, Illinois, 60208
About this study
Official title: The Center for the Neurobiology of Language Recovery (CNLR)
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.
Read the 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.
- Conditions
- Aphasia, Dysgraphia, Anomia, Agrammatism, Stroke
- Being tested
- Treatment Focusing on Naming Objects, Treatment Focusing on Improving Spelling Abilities, Treatment Focusing on Improving Sentence Processing, No Treatment
- Keywords
- Aphasia, Dysgraphia, Anomia, Agrammatism, Stroke, Language Recovery, Treatment, Biomarkers of Recovery
- Medical subject headings
- Aphasia, Agraphia, Anomia, Aphasia, Broca, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment Focusing on Naming ObjectsBehavioural
Also called Language treatment
Treatment will be administered from week 0 until week 12.
Treatment Focusing on Improving Spelling AbilitiesBehavioural
Also called Language Treatment
Treatment will be administered from week 0 until week 12.
Treatment Focusing on Improving Sentence ProcessingBehavioural
Also called Language Treatment
Treatment will be administered from week 0 until week 12.
No TreatmentBehavioural
No treatment will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Naming Deficits | Experimental | 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. Receives: Behavioral: Treatment Focusing on Naming Objects; Behavioral: No Treatment |
| Spelling and/or Writing Deficits | Experimental | 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. Receives: Behavioral: Treatment Focusing on Improving Spelling Abilities; Behavioral: No Treatment |
| Sentence Processing | Experimental | 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. Receives: Behavioral: Treatment Focusing on Improving Sentence Processing; Behavioral: No Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: week 0 to week 12
Secondary outcomes (3)
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
Measured: week 0 to week 12
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.
Measured: week 12 to week 24
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
Measured: week 12 to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2013 (estimated)
- Study startApr 2013
- Primary completion27 Mar 2019
- Study completion27 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (72)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Cynthia K Thompson, PhD, Study director, Northwestern UniversityDavid Caplan, MDCM, PhD, Principal investigator, Harvard University Massachusetts General HospitalBrenda Rapp, PhD, Principal investigator, Johns Hopkins UniversitySwathi Kiran, PhD, CCC-SLP, Principal investigator, Boston UniversityTodd B Parrish, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927302
- Sponsor's protocol ID
- P50
- Other IDs
- P50DC012283
- Status last verified
- Jun 2026
- First submitted
- 29 Jul 2013
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30689268Kiran 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.
PubMed 31001187Crinion 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.
PubMed 22846659Kiran 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.
PubMed 23063559Meinzer 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.
PubMed 22387474Rapp 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.
PubMed 22974976Ditges 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.
PubMed 33918022Thompson 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.
PubMed 31756151Schuchard 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.
PubMed 23532578Wang 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. doi: 10.1016/j.jneuroling.2013.09.001.
PubMed 26379370Thompson 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.
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.
PubMed 33875733Ingo 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;3:11. doi: 10.3389/fphy.2015.00011. Epub 2015 Mar 16.
PubMed 28344972
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Center for the Neurobiology of Language Recovery (CNLR)
- ClinicalTrials.gov ID
- NCT01927302
- Acronym / sponsor ID
- P50
- Conditions
- Aphasia, Dysgraphia, Anomia, Agrammatism, Stroke
- Keywords
- Aphasia, Dysgraphia, Anomia, Agrammatism, Stroke, Language Recovery, Treatment, Biomarkers of Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH)
- Study start
- Apr 2013 (actual)
- Primary completion
- 27 Mar 2019 (actual)
- Study completion
- 27 Mar 2019 (actual)
- First posted
- 22 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Naming Deficits | Experimental | Behavioral: Treatment Focusing on Naming Objects, Behavioral: No TreatmentLanguage 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. |
| Spelling and/or Writing Deficits | Experimental | Behavioral: Treatment Focusing on Improving Spelling Abilities, Behavioral: No TreatmentLanguage 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. |
| Sentence Processing | Experimental | Behavioral: Treatment Focusing on Improving Sentence Processing, Behavioral: No TreatmentLanguage 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. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aphasia following a stroke
- Stoke was at least 1 year ago
- Medically stable
- Right-handed
- Normal or 'corrected to normal' vision and hearing
Key exclusion criteria (1 listed)
- History of neurological disease, head trauma, psychiatric disorders, alcoholism, or developmental speech, language, or learning disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment Focusing on Naming ObjectsAlso: Language treatmentTreatment will be administered from week 0 until week 12. | Behavioural | Naming Deficits |
| Treatment Focusing on Improving Spelling AbilitiesAlso: Language TreatmentTreatment will be administered from week 0 until week 12. | Behavioural | Spelling and/or Writing Deficits |
| Treatment Focusing on Improving Sentence ProcessingAlso: Language TreatmentTreatment will be administered from week 0 until week 12. | Behavioural | Sentence Processing |
| No TreatmentNo treatment will be administered. | Behavioural | Naming Deficits, Sentence Processing, Spelling and/or Writing Deficits |
Primary outcome
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).
3 secondary outcomes
Composite change in brain function as a result of treatment
Time frame: week 0 to week 12
Maintenance of language and cognitive abilities as a result of treatment
Time frame: week 12 to week 24
Maintenance of composite changes in brain function as a result of treatment
Time frame: week 12 to week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Background: PubMed 30689268Walenski 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.
- Background: PubMed 31001187Kiran 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.
- Background: PubMed 22846659Crinion 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.
- Background: PubMed 23063559Kiran 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.
- Background: PubMed 22387474Meinzer 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.
- Background: PubMed 22974976Rapp 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.
- Background: PubMed 33918022Ditges 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.
- Background: PubMed 31756151Thompson 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.
- Background: PubMed 23532578Schuchard 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.
- Background: PubMed 26379370Wang 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. doi: 10.1016/j.jneuroling.2013.09.001.
- BackgroundThompson 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.
- BackgroundThompson 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.
- Boston University's Aphasia Research LaboratoryLink provided by the sponsor.
- Johns Hopkins University's CogNeuro Research LaboratoryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia K Thompson, PhD study director
Northwestern University
David Caplan, MDCM, PhD principal investigator
Harvard University Massachusetts General Hospital
Brenda Rapp, PhD principal investigator
Johns Hopkins University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment Focusing on Naming Objects, Treatment Focusing on Improving Spelling Abilities and Treatment Focusing on Improving Sentence Processing in people with Aphasia and Dysgraphia, run by Northwestern University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in language and cognitive abilities as a result of treatment (time frame: week 0 to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01927302, which also lists 72 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.