AphasiaNCT00076479
Role of the Right Brain in Recovery of Language Function in Chronic Stroke
An observational study of Aphasia and Cerebrovascular Accident, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will examine in healthy individuals and in patients with aphasia (a language disturbance that is usually caused by stroke, brain disease, or injury) which parts of the brain are involved in naming everyday objects. In most people, language and speech originate in the left side of the brain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aphasia, Cerebrovascular Accident
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Jan 2006
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- We will include patients with thromboembolic non-hemorrhagic hemispheric lesions and with hemorrhagic hemispheric lesions (as documented by CT or MRI) at least 12 months after the stroke.
- We will choose subjects with chronic stable aphasia, that initially presented with severe aphasia and have partially recovered.
- Assessment of the initial functional state will be taken either from patient report or medical records. All of the aphasic patients are already known to the investigators from the NIDCD.
Who cannot join
- Unable to perform the task (naming of everyday objects in less than 10 s).
- History of alcohol or drug abuse or psychiatric illness like depression.
- Epilepsy.
- Are less than 18 years of age.
- Pregnant or breast feeding a child.
- Unable to perform the task (naming of everyday objects in less than 10 s).
Show all 14Show fewer
- History of alcohol or drug abuse or psychiatric illness like depression.
- Epilepsy.
- Are less than 18 years of age.
- Pregnant or breast feeding a child.
- Patients with cerebellar or brainstem lesions.
- Patients or subjects with severe uncontrolled medical problems (e.g. cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease).
- Patients or subjects with increased intracranial pressure as evaluated by clinical means.
- Individuals receiving drugs acting primarily on the central nervous system.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
This study will examine in healthy individuals and in patients with aphasia (a language disturbance that is usually caused by stroke, brain disease, or injury) which parts of the brain are involved in naming everyday objects. In most people, language and speech originate in the left side of the brain. When this side of the brain is damaged, language function is often impaired. Often, however, function partly recovers, possibly because the right half of the brain takes over some language functions when the left half is injured.
Healthy volunteers and patients with aphasia due to stroke may be eligible for this study. All candidates must be 18 years of age and older. Patients' aphasia must have occurred as the result of a stroke that occurred more than 12 months before entering the study. In addition, their stroke must not have affected the brainstem or cerebellum. Candidates will be screened with a medical history, brief physical examination, and questionnaire about handedness. Participants will undergo the following tests and procedures:
Read more
Session 1: Magnetic resonance scanning (MRI)
MRI is a diagnostic and research tool that uses a strong magnetic field and radio waves to obtain images of body organs and tissues, including the brain. The subject lies in a cylindrical machine for up to 60 minutes. Loud thumping noises occur when the radiofrequency circuits are switched; this noise can be muffled by the use of earplugs.
Sessions 2 and 3: Picture naming during transcranial magnetic stimulation (TMS)
For transcranial magnetic stimulation, a wire coil is held on the subject's scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The subject hears a click and feels a pulling sensation on the skin under the coil. There may also be a twitch in the muscles of the arm or leg. During the TMS, subjects are asked to name pictures of common everyday objects that appear on a computer screen. They are asked to name them as fast and as accurately as possible. Their voice is recorded to determine the accuracy of their answers and the time it takes to answer. Subjects may also be asked to tense certain muscles slightly or perform other simple actions during the TMS to position the coil properly.
Read the detailed description
Background: Aphasia, a language impairment usually induced by stroke, is typically the result of damage to the left hemisphere. Severity of this disorder can vary across patients, as well as the degree of impairment at various levels of linguistic processes. However, one consistent symptom of aphasia is anomia (or dysnomia) which is a word finding deficit. Given the reliable presence of anomia, picture naming is a common task used both clinically and experimentally to probe linguistic processing.
Functional imaging studies have suggested that the right hemisphere may be recruited to compensate for loss of left hemispheric language regions. However, they could not assess the functional significance of the observed activations. In a previous experiment (NIDCD protocol 92-DC-0178), we have identified the areas activated in association with language function (picture naming) in patients with chronic stroke that have partially recovered from an initially severe aphasia and in healthy, age- and gender-matched controls. The preliminary outcome is increased involvement of the right hemisphere for picture naming in recovered aphasics.
Objectives: In the present protocol, we plan to test the hypothesis that right hemispheric homologues of traditional left hemispheric anterior and posterior language areas are the neural substrate mediating recovery of language functions in patients with chronic stroke. This investigation is important because it can provide novel evidence on plasticity of language functions in chronic stroke.
Study Population: We plan to include chronic stroke patients that suffer from aphasia, and healthy, age- and gender-matched controls.
Design: We will test if inhibitory transcranial magnetic stimulation (TMS) of right-hemispheric cortical areas (inferior frontal gyrus - IFG, superior temporal gyrus - STG, middle temporal gyrus - MTG) that are activated during picture naming will result in a decrease in task performance (picture naming latency) in chronic stroke patients, in comparison to stimulation of left hemispheric areas in aphasics, and right-hemispheric homologue areas in healthy controls. The TMS experiment is necessary to identify a cause-effect link between right hemispheric activation and recovery of language functions after chronic stroke. Stereotactic applications of TMS during the picture naming task will be implemented over six cortical sites in both groups: left IFG, left STG, left MTG, and right IFG, right STG, and right MTG.
Outcome Measures: The outcome measure will be performance on the picture naming task (primary outcome measure reaction time) during TMS as a function of subject group and stimulation site.
- Conditions
- Aphasia, Cerebrovascular Accident
- Keywords
- Aphasia, Rehabilitation, Neuroplasticity, Picture Naming, Transcranial Magnetic, Stroke, Healthy Volunteer, HV
- Medical subject headings
- Aphasia, Stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2004 (estimated)
- Study startJan 2004
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The 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
- Observational
- Enrolment
- 40 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00076479
- Sponsor's protocol ID
- 040100
- Other IDs
- 04-N-0100
- Status last verified
- Jan 2006
- First submitted
- 22 Jan 2004
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Abrahams S, Goldstein LH, Simmons A, Brammer MJ, Williams SC, Giampietro VP, Andrew CM, Leigh PN. Functional magnetic resonance imaging of verbal fluency and confrontation naming using compressed image acquisition to permit overt responses. Hum Brain Mapp. 2003 Sep;20(1):29-40. doi: 10.1002/hbm.10126.
PubMed 12953304Amassian VE, Maccabee PJ, Cracco RQ, Cracco JB, Somasundaram M, Rothwell JC, Eberle L, Henry K, Rudell AP. The polarity of the induced electric field influences magnetic coil inhibition of human visual cortex: implications for the site of excitation. Electroencephalogr Clin Neurophysiol. 1994 Feb;93(1):21-6. doi: 10.1016/0168-5597(94)90087-6.
PubMed 7511518Basso A, Gardelli M, Grassi MP, Mariotti M. The role of the right hemisphere in recovery from aphasia. Two case studies. Cortex. 1989 Dec;25(4):555-66. doi: 10.1016/s0010-9452(89)80017-6.
PubMed 2612175
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Right Brain in Recovery of Language Function in Chronic Stroke
- ClinicalTrials.gov ID
- NCT00076479
- Acronym / sponsor ID
- 040100
- Conditions
- Aphasia, Cerebrovascular Accident
- Keywords
- Aphasia, Rehabilitation, Neuroplasticity, Picture Naming, Transcranial Magnetic, Stroke, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Jan 2004
- Study completion
- Jan 2006
- First posted
- 23 Jan 2004 (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.
This study will examine in healthy individuals and in patients with aphasia (a language disturbance that is usually caused by stroke, brain disease, or injury) which parts of the brain are involved in naming everyday objects. In most people, language and speech originate in the left side of the brain. When this side of the brain is damaged, language function is often impaired. Often, however, function partly recovers, possibly because the right half of the brain takes over some language functions when the left half is injured.
Healthy volunteers and patients with aphasia due to stroke may be eligible for this study. All candidates must be 18 years of age and older. Patients' aphasia must have occurred as the result of a stroke that occurred more than 12 months before entering the study. In addition, their stroke must not have affected the brainstem or cerebellum. Candidates will be screened with a medical history, brief physical examination, and questionnaire about handedness. Participants will undergo the following tests and procedures:
Session 1: Magnetic resonance scanning (MRI)
MRI is a diagnostic and research tool that uses a strong magnetic field and radio waves to obtain images of body organs and tissues, including the brain. The subject lies in a cylindrical machine for up to 60 minutes. Loud thumping noises occur when the radiofrequency circuits are switched; this noise can be muffled by the use of earplugs.
Sessions 2 and 3: Picture naming during transcranial magnetic stimulation (TMS)
For transcranial magnetic stimulation, a wire coil is held on the subject's scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The subject hears a click and feels a pulling sensation on the skin under the coil. There may also be a twitch in the muscles of the arm or leg. During the TMS, subjects are asked to name pictures of common everyday objects that appear on a computer screen. They are asked to name them as fast and as accurately as possible. Their voice is recorded to determine the accuracy of their answers and the time it takes to answer. Subjects may also be asked to tense certain muscles slightly or perform other simple actions during the TMS to position the coil properly.
Detailed description
Background: Aphasia, a language impairment usually induced by stroke, is typically the result of damage to the left hemisphere. Severity of this disorder can vary across patients, as well as the degree of impairment at various levels of linguistic processes. However, one consistent symptom of aphasia is anomia (or dysnomia) which is a word finding deficit. Given the reliable presence of anomia, picture naming is a common task used both clinically and experimentally to probe linguistic processing.
Functional imaging studies have suggested that the right hemisphere may be recruited to compensate for loss of left hemispheric language regions. However, they could not assess the functional significance of the observed activations. In a previous experiment (NIDCD protocol 92-DC-0178), we have identified the areas activated in association with language function (picture naming) in patients with chronic stroke that have partially recovered from an initially severe aphasia and in healthy, age- and gender-matched controls. The preliminary outcome is increased involvement of the right hemisphere for picture naming in recovered aphasics.
Objectives: In the present protocol, we plan to test the hypothesis that right hemispheric homologues of traditional left hemispheric anterior and posterior language areas are the neural substrate mediating recovery of language functions in patients with chronic stroke. This investigation is important because it can provide novel evidence on plasticity of language functions in chronic stroke.
Study Population: We plan to include chronic stroke patients that suffer from aphasia, and healthy, age- and gender-matched controls.
Design: We will test if inhibitory transcranial magnetic stimulation (TMS) of right-hemispheric cortical areas (inferior frontal gyrus - IFG, superior temporal gyrus - STG, middle temporal gyrus - MTG) that are activated during picture naming will result in a decrease in task performance (picture naming latency) in chronic stroke patients, in comparison to stimulation of left hemispheric areas in aphasics, and right-hemispheric homologue areas in healthy controls. The TMS experiment is necessary to identify a cause-effect link between right hemispheric activation and recovery of language functions after chronic stroke. Stereotactic applications of TMS during the picture naming task will be implemented over six cortical sites in both groups: left IFG, left STG, left MTG, and right IFG, right STG, and right MTG.
Outcome Measures: The outcome measure will be performance on the picture naming task (primary outcome measure reaction time) during TMS as a function of subject group and stimulation site.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- We will include patients with thromboembolic non-hemorrhagic hemispheric lesions and with hemorrhagic hemispheric lesions (as documented by CT or MRI) at least 12 months after the stroke.
- We will choose subjects with chronic stable aphasia, that initially presented with severe aphasia and have partially recovered.
- Assessment of the initial functional state will be taken either from patient report or medical records. All of the aphasic patients are already known to the investigators from the NIDCD.
Key exclusion criteria (14 listed)
- Unable to perform the task (naming of everyday objects in less than 10 s).
- History of alcohol or drug abuse or psychiatric illness like depression.
- Epilepsy.
- Are less than 18 years of age.
- Pregnant or breast feeding a child.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 12953304Abrahams S, Goldstein LH, Simmons A, Brammer MJ, Williams SC, Giampietro VP, Andrew CM, Leigh PN. Functional magnetic resonance imaging of verbal fluency and confrontation naming using compressed image acquisition to permit overt responses. Hum Brain Mapp. 2003 Sep;20(1):29-40. doi: 10.1002/hbm.10126.
- Background: PubMed 7511518Amassian VE, Maccabee PJ, Cracco RQ, Cracco JB, Somasundaram M, Rothwell JC, Eberle L, Henry K, Rudell AP. The polarity of the induced electric field influences magnetic coil inhibition of human visual cortex: implications for the site of excitation. Electroencephalogr Clin Neurophysiol. 1994 Feb;93(1):21-6. doi: 10.1016/0168-5597(94)90087-6.
- Background: PubMed 2612175Basso A, Gardelli M, Grassi MP, Mariotti M. The role of the right hemisphere in recovery from aphasia. Two case studies. Cortex. 1989 Dec;25(4):555-66. doi: 10.1016/s0010-9452(89)80017-6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aphasia and Cerebrovascular Accident, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 14 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 4 Mar 2008. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00076479, which also lists 3 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 4 Mar 2008.