AphasiaNCT00843427
fMRI of Language Recovery Following Stroke in Adults
A study testing CIAT in people with Aphasia and Stroke, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to test the effectiveness of constraint-induced aphasia therapy. Read more about this study
- Who is it for?
- Ages 19 years and older
- What is being tested?
- CIAT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Aug 2015
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MCA stroke as indicated by the presence of aphasia and MRI lesion in the LMCA distribution
- Moderate aphasia (Token Test score between 40th and 90th percentile)
- Written informed consent by the patient or the next of kin
Who cannot join
- Underlying degenerative or metabolic disorder or supervening medical illness
- Severe depression or other psychiatric disorder
- Pregnancy
- Any contraindication to an MRI procedure (i.e., metal implants, claustrophobia)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
The purpose of this study is to test the effectiveness of constraint-induced aphasia therapy.
Read the detailed description
Aphasia (difficulty speaking) is one of the most dreaded consequences of stroke. It is associated with high mortality and severe motor, social, and cognitive disability. During the past decade, therapies administered by stroke teams have made great strides in limiting the damage due to a stroke. Unfortunately, progress in aphasia rehabilitation has not experienced the same rapid advancement. Evidence suggests that the brain may have untapped potential for recovery of aphasia after stroke.
Using functional magnetic resonance imaging (fMRI), researchers now are able to examine the areas of the brain that are responsible for language recovery after stroke. Such data may explain how the brain recovers after stroke, and may lead to new therapies to help individuals who have suffered an aphasia-causing stroke.
In this study, researchers will examine the changes the brain undergoes while recovering from an aphasia-causing stroke and the mechanisms that underlie such recovery, and test the effectiveness of a new and promising method of aphasia rehabilitation called constraint-induced aphasia therapy (CIAT). The scientists will perform fMRI studies of brain activation in people who have suffered an aphasia-causing stroke in order to better understand the underlying mechanisms of recovery from aphasia. Specifically the researchers will compare language activation between adults with stroke and children with perinatal and postnatal stroke (from previous studies); map changes in language activation, characterize the patterns of language reorganization that occur following stroke; and use the fMRI measures to assess recovery using CIAT.
The study will last one year, during this time participants will have language testing to evaluate the degree of aphasia and its recovery; and five fMRI scans scheduled at 2 weeks, 6 weeks, 12 weeks, 26 weeks, and 56 weeks. Participants with remaining moderate aphasia will be offered a chance to participate in an extension treatment study that will last up to 3 months (STUDY).
A better understanding of brain changes during recovery from aphasia may help develop new methods to improve recovery.
- Being tested
- CIAT
- Keywords
- aphasia, stroke, functional magnetic resonance imaging, fMRI, language recovery after stroke, constraint-induced aphasia therapy, CIAT
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIATBehavioural
Also called CILT
Patients are to receive constraint-induced aphasia therapy for 2 weeks at 4 hours per day. Detailed description of this intervention is in Szaflarski et al., 2015 Medical Science Monitor.
| Study group | Role | What they receive |
|---|---|---|
| Aphasia - CIAT | Experimental | Patients with aphasia >1 year after left MCA stroke who will be randomized to receive CIAT Receives: Behavioral: CIAT |
| Aphasia - observation | No intervention | Patients with aphasia >1 year after left MCA stroke who will be randomized to no intervention (observation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure is aphasia improvement.
The Token Test was used only for primary screening and study qualification. All participants received NAT which included: (1) the Boston Naming Test (BNT) (Kaplan, Goodglass et al. 1983), (2) the Controlled Oral Word Association Test (Lezak 1995), (3) the Semantic Fluency Test (SFT) (Kozora and Cullum 1995, Lezak 1995), (4) the Complex Ideation subtest from the Boston Diagnostic Aphasia Examination (BDAE) (Goodglass and Kaplan 1972), (5) the Peabody Picture Vocabulary Test III (PPVT III) (Dunn and Dunn 1997), and (6) the Mini-Communicative Activities Log (Mini-CAL) which is a subjective measure of communicative abilities (Pulvermuller, Neininger et al. 2001, Szaflarski, Ball et al. 2008).
Measured: 1 week and 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startSep 2008
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jerzy P Szaflarski, University of Alabama at Birmingham
- Investigators
- Jerzy P. Szaflarski, MD, PhD, Principal investigator, University of Alabama at Birmingham, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843427
- Sponsor's protocol ID
- R01NS048281
- Other IDs
- 1R01NS048281-01A2
- Status last verified
- May 2018
- First submitted
- 12 Feb 2009
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Binder JR, Rao SM, Hammeke TA, Frost JA, Bandettini PA, Jesmanowicz A, Hyde JS. Lateralized human brain language systems demonstrated by task subtraction functional magnetic resonance imaging. Arch Neurol. 1995 Jun;52(6):593-601. doi: 10.1001/archneur.1995.00540300067015.
PubMed 7763208Booth JR, MacWhinney B, Thulborn KR, Sacco K, Voyvodic JT, Feldman HM. Developmental and lesion effects in brain activation during sentence comprehension and mental rotation. Dev Neuropsychol. 2000;18(2):139-69. doi: 10.1207/S15326942DN1802_1.
PubMed 11280962Borod JC, Carper M, Naeser M, Goodglass H. Left-handed and right-handed aphasics with left hemisphere lesions compared on nonverbal performance measures. Cortex. 1985 Mar;21(1):81-90. doi: 10.1016/s0010-9452(85)80017-4.
PubMed 3987313Breier JI, Hasan KM, Zhang W, Men D, Papanicolaou AC. Language dysfunction after stroke and damage to white matter tracts evaluated using diffusion tensor imaging. AJNR Am J Neuroradiol. 2008 Mar;29(3):483-7. doi: 10.3174/ajnr.A0846. Epub 2007 Nov 26.
PubMed 18039757Cao Y, Vikingstad EM, George KP, Johnson AF, Welch KM. Cortical language activation in stroke patients recovering from aphasia with functional MRI. Stroke. 1999 Nov;30(11):2331-40. doi: 10.1161/01.str.30.11.2331.
PubMed 10548667Carlomagno S, Pandolfi M, Labruna L, Colombo A, Razzano C. Recovery from moderate aphasia in the first year poststroke: effect of type of therapy. Arch Phys Med Rehabil. 2001 Aug;82(8):1073-80. doi: 10.1053/apmr.2001.25155.
PubMed 11494187Geschwind N, Galaburda AM. Cerebral lateralization. Biological mechanisms, associations, and pathology: I. A hypothesis and a program for research. Arch Neurol. 1985 May;42(5):428-59. doi: 10.1001/archneur.1985.04060050026008. No abstract available.
PubMed 3994562Hillis AE, Kleinman JT, Newhart M, Heidler-Gary J, Gottesman R, Barker PB, Aldrich E, Llinas R, Wityk R, Chaudhry P. Restoring cerebral blood flow reveals neural regions critical for naming. J Neurosci. 2006 Aug 2;26(31):8069-73. doi: 10.1523/JNEUROSCI.2088-06.2006.
PubMed 16885220Jacola LM, Schapiro MB, Schmithorst VJ, Byars AW, Strawsburg RH, Szaflarski JP, Plante E, Holland SK. Functional magnetic resonance imaging reveals atypical language organization in children following perinatal left middle cerebral artery stroke. Neuropediatrics. 2006 Feb;37(1):46-52. doi: 10.1055/s-2006-923934.
PubMed 16541368Lee RG, van Donkelaar P. Mechanisms underlying functional recovery following stroke. Can J Neurol Sci. 1995 Nov;22(4):257-63. doi: 10.1017/s0317167100039445.
PubMed 8599767Meinzer M, Djundja D, Barthel G, Elbert T, Rockstroh B. Long-term stability of improved language functions in chronic aphasia after constraint-induced aphasia therapy. Stroke. 2005 Jul;36(7):1462-6. doi: 10.1161/01.STR.0000169941.29831.2a. Epub 2005 Jun 9.
PubMed 15947279Meinzer M, Elbert T, Wienbruch C, Djundja D, Barthel G, Rockstroh B. Intensive language training enhances brain plasticity in chronic aphasia. BMC Biol. 2004 Aug 25;2:20. doi: 10.1186/1741-7007-2-20.
PubMed 15331014Muller RA, Rothermel RD, Behen ME, Muzik O, Chakraborty PK, Chugani HT. Language organization in patients with early and late left-hemisphere lesion: a PET study. Neuropsychologia. 1999 May;37(5):545-57. doi: 10.1016/s0028-3932(98)00109-2.
PubMed 10340314Muller RA, Rothermel RD, Behen ME, Muzik O, Mangner TJ, Chugani HT. Differential patterns of language and motor reorganization following early left hemisphere lesion: a PET study. Arch Neurol. 1998 Aug;55(8):1113-9. doi: 10.1001/archneur.55.8.1113.
PubMed 9708962Naeser MA, Borod JC. Aphasia in left-handers: lesion site, lesion side, and hemispheric asymmetries on CT. Neurology. 1986 Apr;36(4):471-88. doi: 10.1212/wnl.36.4.471.
PubMed 3960321
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- fMRI of Language Recovery Following Stroke in Adults
- ClinicalTrials.gov ID
- NCT00843427
- Acronym / sponsor ID
- R01NS048281
- Keywords
- aphasia, stroke, functional magnetic resonance imaging, fMRI, language recovery after stroke, constraint-induced aphasia therapy, CIAT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Sep 2008
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 13 Feb 2009 (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 test the effectiveness of constraint-induced aphasia therapy.
Detailed description
Aphasia (difficulty speaking) is one of the most dreaded consequences of stroke. It is associated with high mortality and severe motor, social, and cognitive disability. During the past decade, therapies administered by stroke teams have made great strides in limiting the damage due to a stroke. Unfortunately, progress in aphasia rehabilitation has not experienced the same rapid advancement. Evidence suggests that the brain may have untapped potential for recovery of aphasia after stroke.
Using functional magnetic resonance imaging (fMRI), researchers now are able to examine the areas of the brain that are responsible for language recovery after stroke. Such data may explain how the brain recovers after stroke, and may lead to new therapies to help individuals who have suffered an aphasia-causing stroke.
In this study, researchers will examine the changes the brain undergoes while recovering from an aphasia-causing stroke and the mechanisms that underlie such recovery, and test the effectiveness of a new and promising method of aphasia rehabilitation called constraint-induced aphasia therapy (CIAT). The scientists will perform fMRI studies of brain activation in people who have suffered an aphasia-causing stroke in order to better understand the underlying mechanisms of recovery from aphasia. Specifically the researchers will compare language activation between adults with stroke and children with perinatal and postnatal stroke (from previous studies); map changes in language activation, characterize the patterns of language reorganization that occur following stroke; and use the fMRI measures to assess recovery using CIAT.
The study will last one year, during this time participants will have language testing to evaluate the degree of aphasia and its recovery; and five fMRI scans scheduled at 2 weeks, 6 weeks, 12 weeks, 26 weeks, and 56 weeks. Participants with remaining moderate aphasia will be offered a chance to participate in an extension treatment study that will last up to 3 months (STUDY).
A better understanding of brain changes during recovery from aphasia may help develop new methods to improve recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aphasia - CIAT | Experimental | Behavioral: CIATPatients with aphasia >1 year after left MCA stroke who will be randomized to receive CIAT |
| Aphasia - observation | No intervention | –Patients with aphasia >1 year after left MCA stroke who will be randomized to no intervention (observation) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- MCA stroke as indicated by the presence of aphasia and MRI lesion in the LMCA distribution
- Moderate aphasia (Token Test score between 40th and 90th percentile)
- Written informed consent by the patient or the next of kin
Key exclusion criteria (4 listed)
- Underlying degenerative or metabolic disorder or supervening medical illness
- Severe depression or other psychiatric disorder
- Pregnancy
- Any contraindication to an MRI procedure (i.e., metal implants, claustrophobia)
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 |
|---|---|---|
| CIATAlso: CILTPatients are to receive constraint-induced aphasia therapy for 2 weeks at 4 hours per day. Detailed description of this intervention is in Szaflarski et al., 2015 Medical Science Monitor. | Behavioural | Aphasia - CIAT |
Primary outcome
Primary outcome measure is aphasia improvement.
Time frame: 1 week and 3 months after intervention
The Token Test was used only for primary screening and study qualification. All participants received NAT which included: (1) the Boston Naming Test (BNT) (Kaplan, Goodglass et al. 1983), (2) the Controlled Oral Word Association Test (Lezak 1995), (3) the Semantic Fluency Test (SFT) (Kozora and Cullum 1995, Lezak 1995), (4) the Complex Ideation subtest from the Boston Diagnostic Aphasia Examination (BDAE) (Goodglass and Kaplan 1972), (5) the Peabody Picture Vocabulary Test III (PPVT III) (Dunn and Dunn 1997), and (6) the Mini-Communicative Activities Log (Mini-CAL) which is a subjective measure of communicative abilities (Pulvermuller, Neininger et al. 2001, Szaflarski, Ball et al. 2008).
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 11 May 2018.
- Background: PubMed 7763208Binder JR, Rao SM, Hammeke TA, Frost JA, Bandettini PA, Jesmanowicz A, Hyde JS. Lateralized human brain language systems demonstrated by task subtraction functional magnetic resonance imaging. Arch Neurol. 1995 Jun;52(6):593-601. doi: 10.1001/archneur.1995.00540300067015.
- Background: PubMed 11280962Booth JR, MacWhinney B, Thulborn KR, Sacco K, Voyvodic JT, Feldman HM. Developmental and lesion effects in brain activation during sentence comprehension and mental rotation. Dev Neuropsychol. 2000;18(2):139-69. doi: 10.1207/S15326942DN1802_1.
- Background: PubMed 3987313Borod JC, Carper M, Naeser M, Goodglass H. Left-handed and right-handed aphasics with left hemisphere lesions compared on nonverbal performance measures. Cortex. 1985 Mar;21(1):81-90. doi: 10.1016/s0010-9452(85)80017-4.
- Background: PubMed 18039757Breier JI, Hasan KM, Zhang W, Men D, Papanicolaou AC. Language dysfunction after stroke and damage to white matter tracts evaluated using diffusion tensor imaging. AJNR Am J Neuroradiol. 2008 Mar;29(3):483-7. doi: 10.3174/ajnr.A0846. Epub 2007 Nov 26.
- Background: PubMed 10548667Cao Y, Vikingstad EM, George KP, Johnson AF, Welch KM. Cortical language activation in stroke patients recovering from aphasia with functional MRI. Stroke. 1999 Nov;30(11):2331-40. doi: 10.1161/01.str.30.11.2331.
- Background: PubMed 11494187Carlomagno S, Pandolfi M, Labruna L, Colombo A, Razzano C. Recovery from moderate aphasia in the first year poststroke: effect of type of therapy. Arch Phys Med Rehabil. 2001 Aug;82(8):1073-80. doi: 10.1053/apmr.2001.25155.
- Background: PubMed 3994562Geschwind N, Galaburda AM. Cerebral lateralization. Biological mechanisms, associations, and pathology: I. A hypothesis and a program for research. Arch Neurol. 1985 May;42(5):428-59. doi: 10.1001/archneur.1985.04060050026008. No abstract available.
- Background: PubMed 16885220Hillis AE, Kleinman JT, Newhart M, Heidler-Gary J, Gottesman R, Barker PB, Aldrich E, Llinas R, Wityk R, Chaudhry P. Restoring cerebral blood flow reveals neural regions critical for naming. J Neurosci. 2006 Aug 2;26(31):8069-73. doi: 10.1523/JNEUROSCI.2088-06.2006.
- Background: PubMed 16541368Jacola LM, Schapiro MB, Schmithorst VJ, Byars AW, Strawsburg RH, Szaflarski JP, Plante E, Holland SK. Functional magnetic resonance imaging reveals atypical language organization in children following perinatal left middle cerebral artery stroke. Neuropediatrics. 2006 Feb;37(1):46-52. doi: 10.1055/s-2006-923934.
- Background: PubMed 8599767Lee RG, van Donkelaar P. Mechanisms underlying functional recovery following stroke. Can J Neurol Sci. 1995 Nov;22(4):257-63. doi: 10.1017/s0317167100039445.
- Background: PubMed 15947279Meinzer M, Djundja D, Barthel G, Elbert T, Rockstroh B. Long-term stability of improved language functions in chronic aphasia after constraint-induced aphasia therapy. Stroke. 2005 Jul;36(7):1462-6. doi: 10.1161/01.STR.0000169941.29831.2a. Epub 2005 Jun 9.
- Background: PubMed 15331014Meinzer M, Elbert T, Wienbruch C, Djundja D, Barthel G, Rockstroh B. Intensive language training enhances brain plasticity in chronic aphasia. BMC Biol. 2004 Aug 25;2:20. doi: 10.1186/1741-7007-2-20.
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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.
Jerzy P. Szaflarski, MD, PhD principal investigator
University of Alabama at Birmingham, Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CIAT in people with Aphasia and Stroke, run by University of Alabama at Birmingham at 1 site 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 3 inclusion and 4 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 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Primary outcome measure is aphasia improvement. (time frame: 1 week and 3 months after intervention). 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 NCT00843427, which also lists 23 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 11 May 2018.