Subcortical AphasiaNCT03668132
Language Functional Reorganization in Subcortical Infarction Patients
An observational study of Subcortical Aphasia and Ischemic Stroke, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.
Trial summary
Post stroke aphasia (PSA) is one of the most frequently happened deficiency of stoke, affecting speaking,comprehension, writing and reading of language. Generally, PSA is commonly seen in cortical damage, but in recent years it has been found that subcortical injury is also an important cause of PSA, which is called… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Subcortical Aphasia, Ischemic Stroke
- What is being tested?
- ischemic brain damage
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 19 Jan 2016to 12 Jan 2017
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The first onset, the onset time was less than 3 days, the lesion was the left and right single subcortical infarct lesion confirmed by head Magnetic Resonance Imaging(MRI).All of them are come from Neurology/Cerebrovascular Department General Hospital of Guangzhou Military Command of PLA between 2016-2017.
Who may be able to join
- The first stroke of the left single subcortical areas, within 72hours.
- Primary school or higher level,aged between 18-75, native language Chinese
- According to the commonly used eye chart examination, the corrected visual acuity is more than 1.0.
- According to the Edinburgh Handedness Questionnaire (EHQ) as the right handed.
- The language function was normal before the onset. After the onset, the language function was mildly to moderately impaired with Western Aphasia Battery (WAB) ( Aphasia Quotient (AQ) between in 60 to 88).
- The patient cooperate with the examination, they and their guardian signed the informed consent
Who cannot join
- History of organic diseases of the nervous system and history of craniocerebral trauma.
- History of epilepsy and psychosis.
- History of material dependence.
- Decompensation of important organ function.
- Hamilton Depression Scale(HAMD )>8 points.
- Hamilton Anxiety Scale(HAMA )>7 points.
Show all 9Show fewer
- The Mini-Mental State Examination (MMSE)score <20 points.
- Pregnant women and breast-feeding women.
- Contraindication of MRI scanning.
Trial locations and contacts
1 site in 1 country.
China1 site
Cerebrovascular Department of General Hospital of Guangzhou Military Command of PLA
Guangzhou, Guangdong, 510010
About this study
Official title: The Language Functional Reorganization Following Subcortical Cerebral Infarction: A Longitudinal fMRI Study
Post stroke aphasia (PSA) is one of the most frequently happened deficiency of stoke, affecting speaking,comprehension, writing and reading of language. Generally, PSA is commonly seen in cortical damage, but in recent years it has been found that subcortical injury is also an important cause of PSA, which is called subcortical aphasia. Using fMRI technology, the investigators aim to investigate the language function of patients with subcortical cerebral infarction at different stages of recovery , and explored the mechanism of post-injury language reorganization in the brain.
The investigators recruited 60 first-episode acute cerebral infarction patients with one-side lesion in subcortical white matter (40 with left injury and 20with right injury) and 20 health volunteers. All participants are right-handed, and screened with MMSE, HAMD and HAMA to exclude cases of psychosis, post-stroke dementia and depression. Each participant was arranged to have three test sessions at different stages after the infarction (T1:within 3 days after onset of the stroke ; T2:28 ±3days after onset; T3: 90±3days after onset), with fMRI and Western aphasia battery (WAB) in each session.
The purpose of this study is to explore the pathogenesis of subcortical aphasia, and to understand the dynamic reorganization of language network during the recovery of language function.
Read the detailed description
The participants were recruited from inpatients with acute ischemic stroke in Department of Cerebrovascular disease, The Guangzhou General Hospital of Guangzhou Military Command. The diagnose of ischemic stroke was made using the diagnostic criteria of the International Association of Neurological Diseases and Stroke Association in 1982. The classification criterias for ischemic stroke were based on the current international TOAST etiological classification method.
The study passed the approval of the ethics committee of General Hospital of Guangzhou Military Command , and all participants or their guardian signed informed consent. According to the location and diagnostic criteria, the participants were divided into three groups: left hemisphere infarction patients group ,right hemisphere infarction patients group and normal healthy control group. The participants performed 3 language functional behavior tests and functional magnetic resonance (fMRI) tests within3 days,28 ±3days ,90±3days after the onset of cerebral infarction. In the healthy control group, the above examination was performed only 1 times. Language functional behavioral assessments included the Chinese version of Western Aphasia Battery(WAB), spontaneous language frequency test(SLFT) and picture naming test(PNT). Examines of fMRI included task-state fMRI , resting-state fMRI and diffusion tensor imaging(DTI).
Task state function magnetic resonance design：Using the block design, each sequence uses the "baseline-stimulus-baseline-stimulus-baseline -stimulus-baseline-stimulus-baseline-stimulus-baseline-stimulus-baseline-stimulus-baseline" model. The first baseline duration is 24s. The following baseline duration and duration of stimulus are 18s, each sequence is 240s, a total of three sequences. Scan 12min. From the Snodgrass picture database, 54 animal pictures and 54 tool pictures can be accurately identified by all subjects. Repeat 6 animal chunk and 6 tool naming chunks, six pictures of each block for 18 seconds. Choose the abstract map of all the American skunk as the baseline map of the animal name, and select the simple arrow picture as the baseline map of the tool. In order to avoid repetition effect after practice, the pictures used in the design of MRI are not repeated in speech behavior assessment. At baseline, subjects were asked to identify the direction of the arrow image and the tail direction of the skunk by silently speaking "upright" or "inverted". The subjects received task familiarization training before testing to ensure that there was no meaningless picture naming in baseline tasks, but location judgment. The design of language task is based on the design of Damasio. In the task state of magnetic resonance scanning, the patient is required to read and name the silent images of the visual images. The visual information is written by the DMDX software, the picture is projected through the brain functional audio-visual stimulation system (SA-9900) to the screen, and the subjects are placed on the head line. The reflector on the circle is observed.
Resting-state fMRI：During the rest-state fMRI scan, no task instruction was given to the participates, and the participates were completely relaxing, closing their eyes, breathing calmly, keeping their head still, but could not fall asleep, tried to avoid any systematic thinking activities, scanning 8min.
Functional magnetic resonance data acquisition：Cranial scanning was performed using the HDX3.0Tesla superconducting magnetic resonance scanner of the US GE company. The 8 channel phased array head coil is the receiving coil, and the scanning sequence and parameters are as follows：
- T1 structure imaging using FSPGR BRAVO sequence. The parameters included: time of repetition, 8.86 ms; time of echo, 3.52 ms; field of view, 24×24 cm2; in-plane resolution,256×256; slice thickness, 1 mm;interslice gap, 1 mm; and number of slices, 176.
- Echo-Planar Imaging (EPI) was used to acquire task-state fMRI data.The parameters included: time of repetition, 3000ms; time of echo, 40 ms; field of view, 24×24 cm2; in-plane resolution,64×64; slice thickness, 4 mm; interslice gap, 1 mm; and number of slices, 34. Scan a sequence of 240s, a total of 12 min.
- Echo-Planar Imaging (EPI) was used to acquire rest-state fMRI data.The parameters included: time of repetition, 3000ms; time of echo, 40 ms; field of view, 24×24 cm2; in-plane resolution,64×64; slice thickness, 4 mm; interslice gap, 1 mm; and number of slices, 34. A total of 8 min.
- Conditions
- Subcortical Aphasia, Ischemic Stroke
- Being tested
- ischemic brain damage
- Keywords
- Aphasia, Functional magnetic resonance imaging, Subcortical aphasia, Post-stroke aphasia, Cortical activation
- Medical subject headings
- Ischemic Stroke, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ischemic brain damageOther
Have or not have the ischemic brain damage and the location of the damage
| Study group | Role | What they receive |
|---|---|---|
| Left damage | Have the ischemic brain damage and the location of the damage ,and in the left brain Receives: Other: ischemic brain damage | |
| Right damage | Have the ischemic brain damage and the location of the damage ,and in the right brain Receives: Other: ischemic brain damage | |
| Normal control | Not have the ischemic brain damage Receives: Other: ischemic brain damage |
What is being measured
The primary outcome is the main question the study is designed to answer.
A change of outcome measure: the Chinese version of Western Aphasia Battery(WAB)
The main outcome measure for this scale is Aphasia Quotient(AQ) which mainly tests the ability of spontaneous speech, oral comprehension, repetition, and naming, and reflects the severity of aphasia, and can be used as a reliable indicator to evaluate the improvement and deterioration of aphasia. Score fluctuation is 0-100 points, the normal value is 98.4-100 points, AQ<93.8 can be judged as language dysfunction.
Measured: This is an outcome measure to assess the improvement of language function from onset to 3 months after treatment. Thus, participates will undergo this assessment within 3 days (V1), 28±3 days (V2), and 90±3 days(V3) after randomization.
Secondary outcomes (3)
A change of outcome measure: Spontaneous Language Frequency Test(SLFT)
This test mainly assesses spontaneous speech fluency of participants. It requires participants name as many food names as possible within one minute, and each correct one to give one point. The higher the score, the better the language function.
Measured: This is an outcome measure to assess the improvement of language function from onset to 3 months after treatment. Thus, participates will undergo this assessment within 3 days (V1), 28±3 days (V2), and 90±3 days(V3) after randomization.
A change of outcome measure: Picture Naming Test(PNT)
This test mainly assesses the ability of picture name of participants. we used a program for displaying named pictures on a computer screen (60 photos in total, of which 20 were Chinese celebrity faces). Each image was displayed in 3 seconds, and 1 point was correctly named for an image. The faces of celebrities were selected from the picture database of Chinese celebrities in the State Key Laboratory of Cognitive Neuroscience and Learning at Beijing Normal University. Score fluctuation is 0-60 points, the higher the score, the better the ability of picture name.
Measured: This is an outcome measure to assess the improvement of language function from onset to 3 months after treatment. Thus, participates will undergo this assessment on the within 3 days (V1), 28±3 days (V2), and 90±3 days(V3) after randomization.
Follow-up measurement:Functional Magnetic Resonance Imaging(fMRI)
The examine included task-state fMRI and resting-state fMRI Time Frame: We will explore the mechanisms of dynamic changes in language functions. Thus, participates will undergo this examine on the first days (V1), 28±3 days (V2), and 90±3 days (V3) after randomization..
Measured: This is an outcome measure to assess the improvement of language function from onset to 3 months after treatment. Thus, participates will undergo this assessment within 3 days (V1), 28±3 days (V2), and 90±3 days(V3) after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start19 Jan 2016
- Primary completion9 Oct 2016
- Study completion12 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (63)Papers the sponsor has linked to this study.
- Other trials for Subcortical AphasiaStudies of the same condition, open and under way.
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military Command
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Liu, Guangzhou General Hospital of Guangzhou Military Command
- Investigators
- Liu Yan, PhD, Study chair, Guangzhou General Hospital of Guangzhou Military Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668132
- Sponsor's protocol ID
- LY-89514138
- Status last verified
- Oct 2018
- First submitted
- 10 Sep 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pedersen PM, Jorgensen HS, Nakayama H, Raaschou HO, Olsen TS. Aphasia in acute stroke: incidence, determinants, and recovery. Ann Neurol. 1995 Oct;38(4):659-66. doi: 10.1002/ana.410380416.
PubMed 7574464Berthier ML. Poststroke aphasia : epidemiology, pathophysiology and treatment. Drugs Aging. 2005;22(2):163-82. doi: 10.2165/00002512-200522020-00006.
PubMed 15733022Engelter ST, Gostynski M, Papa S, Frei M, Born C, Ajdacic-Gross V, Gutzwiller F, Lyrer PA. Epidemiology of aphasia attributable to first ischemic stroke: incidence, severity, fluency, etiology, and thrombolysis. Stroke. 2006 Jun;37(6):1379-84. doi: 10.1161/01.STR.0000221815.64093.8c. Epub 2006 May 11.
PubMed 16690899Pizzamiglio L, Galati G, Committeri G. The contribution of functional neuroimaging to recovery after brain damage: a review. Cortex. 2001 Feb;37(1):11-31. doi: 10.1016/s0010-9452(08)70555-0.
PubMed 11292157Fridriksson J, Holland AL, Coull BM, Plante E, Trouard TP, Beeson P. Aphasia severity: Association with cerebral perfusion and diffusion. Aphasiology. 2002 Sep 1;16(9):859-871. doi: 10.1080/02687030244000347.
PubMed 16823466Hillis 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 16885220Seitz RJ, Azari NP, Knorr U, Binkofski F, Herzog H, Freund HJ. The role of diaschisis in stroke recovery. Stroke. 1999 Sep;30(9):1844-50. doi: 10.1161/01.str.30.9.1844.
PubMed 10471434Kwakkel G, Kollen B, Lindeman E. Understanding the pattern of functional recovery after stroke: facts and theories. Restor Neurol Neurosci. 2004;22(3-5):281-99.
PubMed 15502272Warburton E, Price CJ, Swinburn K, Wise RJ. Mechanisms of recovery from aphasia: evidence from positron emission tomography studies. J Neurol Neurosurg Psychiatry. 1999 Feb;66(2):155-61. doi: 10.1136/jnnp.66.2.155.
PubMed 10071093Szaflarski JP, Allendorfer JB, Banks C, Vannest J, Holland SK. Recovered vs. not-recovered from post-stroke aphasia: the contributions from the dominant and non-dominant hemispheres. Restor Neurol Neurosci. 2013;31(4):347-60. doi: 10.3233/RNN-120267.
PubMed 23482065Heiss WD, Kessler J, Thiel A, Ghaemi M, Karbe H. Differential capacity of left and right hemispheric areas for compensation of poststroke aphasia. Ann Neurol. 1999 Apr;45(4):430-8. doi: 10.1002/1531-8249(199904)45:43.0.co;2-p.
PubMed 10211466Rosen HJ, Petersen SE, Linenweber MR, Snyder AZ, White DA, Chapman L, Dromerick AW, Fiez JA, Corbetta MD. Neural correlates of recovery from aphasia after damage to left inferior frontal cortex. Neurology. 2000 Dec 26;55(12):1883-94. doi: 10.1212/wnl.55.12.1883.
PubMed 11134389Meinzer M, Flaisch T, Breitenstein C, Wienbruch C, Elbert T, Rockstroh B. Functional re-recruitment of dysfunctional brain areas predicts language recovery in chronic aphasia. Neuroimage. 2008 Feb 15;39(4):2038-46. doi: 10.1016/j.neuroimage.2007.10.008. Epub 2007 Oct 18.
PubMed 18096407Calvert GA, Brammer MJ, Morris RG, Williams SC, King N, Matthews PM. Using fMRI to study recovery from acquired dysphasia. Brain Lang. 2000 Feb 15;71(3):391-9. doi: 10.1006/brln.1999.2272.
PubMed 10716869Lazar RM, Marshall RS, Pile-Spellman J, Duong HC, Mohr JP, Young WL, Solomon RL, Perera GM, DeLaPaz RL. Interhemispheric transfer of language in patients with left frontal cerebral arteriovenous malformation. Neuropsychologia. 2000;38(10):1325-32. doi: 10.1016/s0028-3932(00)00054-3.
PubMed 10869575
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Language Functional Reorganization Following Subcortical Cerebral Infarction: A Longitudinal fMRI Study
- ClinicalTrials.gov ID
- NCT03668132
- Acronym / sponsor ID
- LY-89514138
- Conditions
- Subcortical Aphasia, Ischemic Stroke
- Keywords
- Aphasia, Functional magnetic resonance imaging, Subcortical aphasia, Post-stroke aphasia, Cortical activation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military CommandUniversity, hospital or other
- Study start
- 19 Jan 2016 (actual)
- Primary completion
- 9 Oct 2016 (actual)
- Study completion
- 12 Jan 2017 (actual)
- First posted
- 12 Sep 2018 (actual)
- 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.
Post stroke aphasia (PSA) is one of the most frequently happened deficiency of stoke, affecting speaking,comprehension, writing and reading of language. Generally, PSA is commonly seen in cortical damage, but in recent years it has been found that subcortical injury is also an important cause of PSA, which is called subcortical aphasia. Using fMRI technology, the investigators aim to investigate the language function of patients with subcortical cerebral infarction at different stages of recovery , and explored the mechanism of post-injury language reorganization in the brain.
The investigators recruited 60 first-episode acute cerebral infarction patients with one-side lesion in subcortical white matter (40 with left injury and 20with right injury) and 20 health volunteers. All participants are right-handed, and screened with MMSE, HAMD and HAMA to exclude cases of psychosis, post-stroke dementia and depression. Each participant was arranged to have three test sessions at different stages after the infarction (T1:within 3 days after onset of the stroke ; T2:28 ±3days after onset; T3: 90±3days after onset), with fMRI and Western aphasia battery (WAB) in each session.
The purpose of this study is to explore the pathogenesis of subcortical aphasia, and to understand the dynamic reorganization of language network during the recovery of language function.
Detailed description
The participants were recruited from inpatients with acute ischemic stroke in Department of Cerebrovascular disease, The Guangzhou General Hospital of Guangzhou Military Command. The diagnose of ischemic stroke was made using the diagnostic criteria of the International Association of Neurological Diseases and Stroke Association in 1982. The classification criterias for ischemic stroke were based on the current international TOAST etiological classification method.
The study passed the approval of the ethics committee of General Hospital of Guangzhou Military Command , and all participants or their guardian signed informed consent. According to the location and diagnostic criteria, the participants were divided into three groups: left hemisphere infarction patients group ,right hemisphere infarction patients group and normal healthy control group. The participants performed 3 language functional behavior tests and functional magnetic resonance (fMRI) tests within3 days,28 ±3days ,90±3days after the onset of cerebral infarction. In the healthy control group, the above examination was performed only 1 times. Language functional behavioral assessments included the Chinese version of Western Aphasia Battery(WAB), spontaneous language frequency test(SLFT) and picture naming test(PNT). Examines of fMRI included task-state fMRI , resting-state fMRI and diffusion tensor imaging(DTI).
Task state function magnetic resonance design：Using the block design, each sequence uses the "baseline-stimulus-baseline-stimulus-baseline -stimulus-baseline-stimulus-baseline-stimulus-baseline-stimulus-baseline-stimulus-baseline" model. The first baseline duration is 24s. The following baseline duration and duration of stimulus are 18s, each sequence is 240s, a total of three sequences. Scan 12min. From the Snodgrass picture database, 54 animal pictures and 54 tool pictures can be accurately identified by all subjects. Repeat 6 animal chunk and 6 tool naming chunks, six pictures of each block for 18 seconds. Choose the abstract map of all the American skunk as the baseline map of the animal name, and select the simple arrow picture as the baseline map of the tool. In order to avoid repetition effect after practice, the pictures used in the design of MRI are not repeated in speech behavior assessment. At baseline, subjects were asked to identify the direction of the arrow image and the tail direction of the skunk by silently speaking "upright" or "inverted". The subjects received task familiarization training before testing to ensure that there was no meaningless picture naming in baseline tasks, but location judgment. The design of language task is based on the design of Damasio. In the task state of magnetic resonance scanning, the patient is required to read and name the silent images of the visual images. The visual information is written by the DMDX software, the picture is projected through the brain functional audio-visual stimulation system (SA-9900) to the screen, and the subjects are placed on the head line. The reflector on the circle is observed.
Resting-state fMRI：During the rest-state fMRI scan, no task instruction was given to the participates, and the participates were completely relaxing, closing their eyes, breathing calmly, keeping their head still, but could not fall asleep, tried to avoid any systematic thinking activities, scanning 8min.
Functional magnetic resonance data acquisition：Cranial scanning was performed using the HDX3.0Tesla superconducting magnetic resonance scanner of the US GE company. The 8 channel phased array head coil is the receiving coil, and the scanning sequence and parameters are as follows：
- T1 structure imaging using FSPGR BRAVO sequence. The parameters included: time of repetition, 8.86 ms; time of echo, 3.52 ms; field of view, 24×24 cm2; in-plane resolution,256×256; slice thickness, 1 mm;interslice gap, 1 mm; and number of slices, 176.
- Echo-Planar Imaging (EPI) was used to acquire task-state fMRI data.The parameters included: time of repetition, 3000ms; time of echo, 40 ms; field of view, 24×24 cm2; in-plane resolution,64×64; slice thickness, 4 mm; interslice gap, 1 mm; and number of slices, 34. Scan a sequence of 240s, a total of 12 min.
- Echo-Planar Imaging (EPI) was used to acquire rest-state fMRI data.The parameters included: time of repetition, 3000ms; time of echo, 40 ms; field of view, 24×24 cm2; in-plane resolution,64×64; slice thickness, 4 mm; interslice gap, 1 mm; and number of slices, 34. A total of 8 min.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Left damage | – | Other: ischemic brain damageHave the ischemic brain damage and the location of the damage ,and in the left brain |
| Right damage | – | Other: ischemic brain damageHave the ischemic brain damage and the location of the damage ,and in the right brain |
| Normal control | – | Other: ischemic brain damageNot have the ischemic brain damage |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The first onset, the onset time was less than 3 days, the lesion was the left and right single subcortical infarct lesion confirmed by head Magnetic Resonance Imaging(MRI).All of them are come from Neurology/Cerebrovascular Department General Hospital of Guangzhou Military Command of PLA between 2016-2017.
Key inclusion criteria (6 listed)
- The first stroke of the left single subcortical areas, within 72hours.
- Primary school or higher level,aged between 18-75, native language Chinese
- According to the commonly used eye chart examination, the corrected visual acuity is more than 1.0.
- According to the Edinburgh Handedness Questionnaire (EHQ) as the right handed.
- The language function was normal before the onset. After the onset, the language function was mildly to moderately impaired with Western Aphasia Battery (WAB) ( Aphasia Quotient (AQ) between in 60 to 88).
Key exclusion criteria (9 listed)
- History of organic diseases of the nervous system and history of craniocerebral trauma.
- History of epilepsy and psychosis.
- History of material dependence.
- Decompensation of important organ function.
- Hamilton Depression Scale(HAMD )>8 points.
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 |
|---|---|---|
| ischemic brain damageHave or not have the ischemic brain damage and the location of the damage | Other | Left damage, Normal control, Right damage |
Primary outcome
A change of outcome measure: the Chinese version of Western Aphasia Battery(WAB)
Time frame: This is an outcome measure to assess the improvement of language function from onset to 3 months after treatment. Thus, participates will undergo this assessment within 3 days (V1), 28±3 days (V2), and 90±3 days(V3) after randomization.
The main outcome measure for this scale is Aphasia Quotient(AQ) which mainly tests the ability of spontaneous speech, oral comprehension, repetition, and naming, and reflects the severity of aphasia, and can be used as a reliable indicator to evaluate the improvement and deterioration of aphasia. Score fluctuation is 0-100 points, the normal value is 98.4-100 points, AQ<93.8 can be judged as language dysfunction.
3 secondary outcomes
A change of outcome measure: Spontaneous Language Frequency Test(SLFT)
Time frame: This is an outcome measure to assess the improvement of language function from onset to 3 months after treatment. Thus, participates will undergo this assessment within 3 days (V1), 28±3 days (V2), and 90±3 days(V3) after randomization.
A change of outcome measure: Picture Naming Test(PNT)
Time frame: This is an outcome measure to assess the improvement of language function from onset to 3 months after treatment. Thus, participates will undergo this assessment on the within 3 days (V1), 28±3 days (V2), and 90±3 days(V3) after randomization.
Follow-up measurement:Functional Magnetic Resonance Imaging(fMRI)
Time frame: This is an outcome measure to assess the improvement of language function from onset to 3 months after treatment. Thus, participates will undergo this assessment within 3 days (V1), 28±3 days (V2), and 90±3 days(V3) after randomization.
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 9 Oct 2018.
- Background: PubMed 7574464Pedersen PM, Jorgensen HS, Nakayama H, Raaschou HO, Olsen TS. Aphasia in acute stroke: incidence, determinants, and recovery. Ann Neurol. 1995 Oct;38(4):659-66. doi: 10.1002/ana.410380416.
- Background: PubMed 15733022Berthier ML. Poststroke aphasia : epidemiology, pathophysiology and treatment. Drugs Aging. 2005;22(2):163-82. doi: 10.2165/00002512-200522020-00006.
- Background: PubMed 16690899Engelter ST, Gostynski M, Papa S, Frei M, Born C, Ajdacic-Gross V, Gutzwiller F, Lyrer PA. Epidemiology of aphasia attributable to first ischemic stroke: incidence, severity, fluency, etiology, and thrombolysis. Stroke. 2006 Jun;37(6):1379-84. doi: 10.1161/01.STR.0000221815.64093.8c. Epub 2006 May 11.
- Background: PubMed 11292157Pizzamiglio L, Galati G, Committeri G. The contribution of functional neuroimaging to recovery after brain damage: a review. Cortex. 2001 Feb;37(1):11-31. doi: 10.1016/s0010-9452(08)70555-0.
- Background: PubMed 16823466Fridriksson J, Holland AL, Coull BM, Plante E, Trouard TP, Beeson P. Aphasia severity: Association with cerebral perfusion and diffusion. Aphasiology. 2002 Sep 1;16(9):859-871. doi: 10.1080/02687030244000347.
- 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 10471434Seitz RJ, Azari NP, Knorr U, Binkofski F, Herzog H, Freund HJ. The role of diaschisis in stroke recovery. Stroke. 1999 Sep;30(9):1844-50. doi: 10.1161/01.str.30.9.1844.
- Background: PubMed 15502272Kwakkel G, Kollen B, Lindeman E. Understanding the pattern of functional recovery after stroke: facts and theories. Restor Neurol Neurosci. 2004;22(3-5):281-99.
- Background: PubMed 10071093Warburton E, Price CJ, Swinburn K, Wise RJ. Mechanisms of recovery from aphasia: evidence from positron emission tomography studies. J Neurol Neurosurg Psychiatry. 1999 Feb;66(2):155-61. doi: 10.1136/jnnp.66.2.155.
- Background: PubMed 23482065Szaflarski JP, Allendorfer JB, Banks C, Vannest J, Holland SK. Recovered vs. not-recovered from post-stroke aphasia: the contributions from the dominant and non-dominant hemispheres. Restor Neurol Neurosci. 2013;31(4):347-60. doi: 10.3233/RNN-120267.
- Background: PubMed 10211466Heiss WD, Kessler J, Thiel A, Ghaemi M, Karbe H. Differential capacity of left and right hemispheric areas for compensation of poststroke aphasia. Ann Neurol. 1999 Apr;45(4):430-8. doi: 10.1002/1531-8249(199904)45:43.0.co;2-p.
- Background: PubMed 11134389Rosen HJ, Petersen SE, Linenweber MR, Snyder AZ, White DA, Chapman L, Dromerick AW, Fiez JA, Corbetta MD. Neural correlates of recovery from aphasia after damage to left inferior frontal cortex. Neurology. 2000 Dec 26;55(12):1883-94. doi: 10.1212/wnl.55.12.1883.
- Individual participant dataSharing planned: Undecided
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.
Liu Yan, PhD study chair
Guangzhou General Hospital of Guangzhou Military Command
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 Subcortical Aphasia and Ischemic Stroke, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.
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 6 inclusion and 9 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 9 Oct 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 China. 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?
A change of outcome measure: the Chinese version of Western Aphasia Battery(WAB) (time frame: This is an outcome measure to assess the improvement of language function from onset to 3 months after treatment. Thus, participates will undergo this assessment within 3 days (V1), 28±3 days (V2), and 90±3 days(V3) after randomization.). 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 NCT03668132, which also lists 63 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 9 Oct 2018.