Ischemic StrokeNCT04794673
Cortex Motor Function Reorganization in Stroke Patients
An observational study of Ischemic Stroke, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.
Trial summary
In China, stroke is among the highest morbidity and mortality, especially in senile population. Most of those patients had survived with various degrees of cerebral dysfunction; among them about 50% were motor deficit. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- brain damage
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2020to 30 Aug 2020
- 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: We plan to recruite first-episode acute cerebral infarction patients with single lesion on middle cerebral artery supply area and age and sex matched healthy volunteers.
Who may be able to join
- The first onset, the lesion was the single lesion of infarction or hemorrhage confirmed by head Magnetic Resonance Imaging(MRI) or Computed Tomography(CT).
- Hemiplegic hand muscle strength above grade 3, and was able to cooperate with the stimulation task of f MRI examination.
- According to the Edinburgh Handedness Questionnaire (EHQ) as the right hand.
- According to the commonly used eye chart examination, the naked eye vision >4.9.
- There is no central nervous system organic disease and other motor diseases that can affect hand function.
- No previous long-term alcoholism and long-term use of central nervous system activity and other drugs treatment.
- No contraindication to MRI scan.
- The patient cooperated with the examination and the patient or their guardian signed an informed consent.
Who cannot join
- Previous diseases of the central nervous system and peripheral nervous system that significantly affected the motor function of limbs.
- Significant cognitive impairment, MMSE≤27.
- Subjects was engaged in professional music playing or keyboard operation before illness.
- The level of consciousness drops after the illness.
- Significant anxiety and depression status (Hamilton anxiety scale ≥14 points, Hamilton depression scale ≥13 points) and other mental illness and history.
- Aphasia and neglect.
Show all 11Show fewer
- History of epilepsy
- History of drug dependence
- Liver dysfunction, renal dysfunction, heart failure or other important organ function loss compensation
- Contraindication to MRI scan.
- Refuse to provide written consent or fail to cooperate with inspection for other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of Southern Theatre Command,PLA
Guangzhou, Guangdong, 510010
About this study
Official title: Cortex Motor Function Reorganization in Stroke Patients: A Longitudinal fMRI Study
In China, stroke is among the highest morbidity and mortality, especially in senile population. Most of those patients had survived with various degrees of cerebral dysfunction; among them about 50% were motor deficit. Previous in vitro studies indicated that recovery of motor function after stroke were related not only to axonal regeneration or synapse reformation, but also functional reorganization of adjacent areas and other functional associated areas. The previous fMRI studies shown that the cerebral motor cortex possess the natural ability of self compensation and self reorganization in the situation of brain damage. It was characterized by equally bilateral activation in acute stage to partial ipsilateral activation and major contralateral activation in subacute stage to contralateral activation in chronic stage.
We plan to recruit first-episode acute cerebral infarction patients with single lesion on middle cerebral artery supply area and age and sex matched healthy volunteers. All the patients are going to assess in three different sessions (V1, 3 days after the onset of complaint, V2,30 days after onset of complaint; V3, 90 days after onset of the complaint ) with both clinical check as well as fMRI scan. The clinical assessment including dynamometer and finger tapping test to evaluate the strength and the flexibility of each upper legs and it also included the corresponding scales to exclude poststroke dementia and moderate and serious poststroke depression. The fMRI is scanned by using bilateral arm motor tasks. Motor cortex activation regions, activation of voxel between healthy controls and patients in different checkpoint are collected.
The purpose of this study is to investigate the dynamic process of motor cortical functional reorganization after cerebral stoke using functional magnetic resonance imaging combined with the behavior assessment. Meanwhile，we also studied the differences of motor function recovery and motor cortex compensation between dominant hemisphere and non-dominant hemisphere after stroke. Therefore, we could provide a theoretical basis and build up a useful evaluation system for rehabilitation after stroke and other arious cerebral injury.
Read the detailed description
The cases derive from patients with acute ischemic stroke hospitalized in Neurology Department General Hospital of Guangzhou Military Command of PLA. The diagnosis of ischemic stroke is diagnosed using the diagnostic criteria of the International Association of Neurological Diseases and Stroke Association in 1982. The classification criteria for ischemic stroke are 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 of PLA, and all patients or their guardian sign informed consent. According to the location and diagnostic criteria, the patients are divided into three groups: left hemisphere infarction patients group, right hemisphere infarction patients group and normal healthy control group. The subjects performed index finger tapping test, the maximum hand grip strength test of both hands, National Institute of Health stroke scale(NIHSS), Barthel Index(BI), Hamilton Anxiety Scale(HAMA), Hamilton Anxiety Scale(HAMA) and functional magnetic resonance (fMRI) tests at 3 days (V1), 30 days (V2) and 90 days (V3 phase) after the onset of cerebral infarction. In the healthy control group, the above examination is performed only 1 times. All subjects are assessed for clinical behavior by an independent third party.
Task-state function magnetic resonance design: Using the block design. There are two sequences. One sequence is in the way of rest and left hand movement, then repeat 5 times, ending at rest. The other is in the way of rest and right hand movement, then repeat 5 times, ending at rest. Each sequence lasted 220s, and the total duration of all tests was 440s. At the hand movement stage, each participant is at 1HZ Rhythm for the clenched fist movement with maximum strength, keep their whole body relaxed at the resting phase, with wrist and fingers not moving. participants use visual information to strictly control time and frequency of movement. Visual information is written by DMDX software, and accept the work instruction then sent to a transparent screen via a computer projector. Participants observed the information through a reflector mounted on a head coil.
Magnetic resonance data acquisition: 1.5 Tesla superconducting magnetic resonance scanner of Siemens Sonata company is applied. The standard phased array head coil is the radio frequency coil. Gradient field is 40m T/m, and switching rate is 200m T/m/ms. The scanning sequence and parameters are as follows:(1) T1 WI scan, obtaining whole brain structure image data: repeat time is 683ms, echo time is 11ms, layer thickness is 4mm, layer spacing is 1mm, matrix is 192x144, field of vision is 230mmx230mm, a total of 28 layers, range including whole brain. (2) The blood oxygen level dependent signal of the motor task state and resting state functional magnetic resonance imaging: using gradient echo combined with single excitation echo plane Imaging technology, the parameters are as follows: repeat time is 2000ms, echo time is 49ms, layer thickness is 4mm, layer spacing is 1mm, matrix is 64x64, field of vision is 210mmx210mm, a total of 28 layers.
- Conditions
- Ischemic Stroke
- Being tested
- brain damage
- Keywords
- motor cortex reorganization, Ischemic Stroke, fMRI, BOLD
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brain damageOther
Have or not have the brain damage and the location of the damage
| Study group | Role | What they receive |
|---|---|---|
| Left damage | Have the brain damage and the location of the damage in the left brain Receives: Other: brain damage | |
| Right damage | Have the brain damage and the location of the damage in the right brain Receives: Other: brain damage | |
| Nomal control | Not have the brain damage Receives: Other: brain damage |
What is being measured
The primary outcome is the main question the study is designed to answer.
A change of outcome measure: Index finger tapping test
The primary measure is the number of clicks that one index finger makes on the mouse as quickly as possible in 10 seconds.The subject took a sitting position and tapped the mouse with his index finger to record the fastest number of taps within 10 seconds.
Measured: This is an outcome measure to assess the improvement of motor function from onset to 3 months after treatment. Thus, participates will undergo this assessment on the 3 days (V1), 30 days (V2), and 90 days (V3) after randomization.
A change of outcome measure: The maximum hand grip strength test
Grip dynamometer(Beijing xintong sport equipment co. LTD, WCS-99.9 digital display electric the child dynamometer), in kilograms. To facilitate the maximum grip strength of one hand, the patient may place the arm in any position during the measurement, no body contact, elbows may be flexed or extended.
Measured: This is an outcome measure to assess the improvement of motor function from onset to 3 months after treatment. Thus, participates will undergo this assessment on the 3 days (V1), 30days (V2), and 90 days (V3) after randomization.
Secondary outcomes (5)
A change of outcome measure: 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 3days (V1), 30 days (V2), and 90days (V3) after randomization.
Measured: We must determine that the participant is not in moderate or more cognitive impairment at each follow-up. Thus, participates will undergo this assessment on the 3 days (V1), 30 days (V2), and 90 days (V3) after randomization.
National Institute of Health stroke scale(NIHSS )
The National Institutes of Health Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.NIHSS Scoring Instructions:0=No stroke symptoms, 1-4=Minor stroke, 5-15=Moderate stroke, 16-20=Moderate to severe stroke, 21-42=Severe stroke(i.e., The higher the score, the more severe the stroke).
Measured: In order to ensure that participants can cooperate with our study, this assessment will be performed before randomization.
Follow-up measurement: Hamilton Depression Rating Scale (HAMD)
The Hamilton Depression Rating Scale (HAMD) has proven useful for many years as a way of determining a patient's level of depression before, during, and after treatment. It generally takes 15-20 minutes to complete the interview and score the results. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine items are scored from 0-2. HAMD Scoring Instructions:0-7=Normal, 8-13 = Mild Depression, 14-18 = Moderate Depression, 19-22 = Severe Depression, ≥ 23 = Very Severe Depression(i.e.,the higher the score, the greater the likelihood of depression).
Measured: We must determine that the participant is not in depression at each follow-up. Thus, participates will undergo this assessment on the 3 days (V1), 30 days (V2), and 90 days (V3) after randomization.
Follow-up measurement: Hamilton Anxiety Rating Scale (HAMA)
The Hamilton Anxiety Rating Scale (HAMA) is a widely used and well-validated tool for measuring the severity of a patient's anxiety. The HAMA is composed of 14 items and takes 15-20 minutes to complete the interview and score the results. Each item is scored on a 5-point scale, ranging from 0=not present to 4=severe.HAMA Scoring Instructions:0-8=Normal, 8-13= Possible Anxiety, 14-17 = Mild Anxiety, 18-24 = Moderate Anxiety, 25-30 = Severe Anxiety(i.e.,the higher the score, the greater the likelihood of anxiety).
Measured: We must determine that the participant is not in anxiety at each follow-up. Thus, participates will undergo this assessment on the 3 days (V1), 30 days (V2), and 90 days (V3) after randomization.
Follow-up measurement: Mini-Mental State Examination (MMSE)
The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Administration of the test takes between 5 and 10 minutes. The MMSE test includes simple questions and problems in a number of areas: the time and place of the test, repeating lists of words, arithmetic such as the serial sevens, language use and comprehension, and basic motor skills. Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.The raw score may also need to be corrected for educational attainment and age.
Measured: We must determine that the participant is not in moderate or more cognitive impairment at each follow-up. Thus, participates will undergo this assessment on the 3 days (V1), 30 days (V2), and 90 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 Mar 2021
- Study start12 Jan 2020
- Primary completion12 Aug 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies 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
- Other
- Enrolment
- 36 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
- Yan LIU, PhD, Study chair, Guangzhou General of Guangzhou Military Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794673
- Sponsor's protocol ID
- LY-81825105
- Status last verified
- Mar 2020
- First submitted
- 9 Mar 2021
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Brown DL, Lisabeth LD, Garcia NM, Smith MA, Morgenstern LB. Emergency department evaluation of ischemic stroke and TIA: the BASIC Project. Neurology. 2004 Dec 28;63(12):2250-4. doi: 10.1212/01.wnl.0000147292.64051.9b.
PubMed 15623682Kokotilo KJ, Eng JJ, McKeown MJ, Boyd LA. Greater activation of secondary motor areas is related to less arm use after stroke. Neurorehabil Neural Repair. 2010 Jan;24(1):78-87. doi: 10.1177/1545968309345269. Epub 2009 Sep 8.
PubMed 19737873Swayne OB, Rothwell JC, Ward NS, Greenwood RJ. Stages of motor output reorganization after hemispheric stroke suggested by longitudinal studies of cortical physiology. Cereb Cortex. 2008 Aug;18(8):1909-22. doi: 10.1093/cercor/bhm218. Epub 2008 Jan 29.
PubMed 18234688O'Shea J, Johansen-Berg H, Trief D, Gobel S, Rushworth MF. Functionally specific reorganization in human premotor cortex. Neuron. 2007 May 3;54(3):479-90. doi: 10.1016/j.neuron.2007.04.021.
PubMed 17481399Lotze M, Markert J, Sauseng P, Hoppe J, Plewnia C, Gerloff C. The role of multiple contralesional motor areas for complex hand movements after internal capsular lesion. J Neurosci. 2006 May 31;26(22):6096-102. doi: 10.1523/JNEUROSCI.4564-05.2006.
PubMed 16738254Cramer SC, Nelles G, Benson RR, Kaplan JD, Parker RA, Kwong KK, Kennedy DN, Finklestein SP, Rosen BR. A functional MRI study of subjects recovered from hemiparetic stroke. Stroke. 1997 Dec;28(12):2518-27. doi: 10.1161/01.str.28.12.2518.
PubMed 9412643Rossini PM, Dal Forno G. Integrated technology for evaluation of brain function and neural plasticity. Phys Med Rehabil Clin N Am. 2004 Feb;15(1):263-306. doi: 10.1016/s1047-9651(03)00124-4.
PubMed 15029909Nelles G, Spiekramann G, Jueptner M, Leonhardt G, Muller S, Gerhard H, Diener HC. Evolution of functional reorganization in hemiplegic stroke: a serial positron emission tomographic activation study. Ann Neurol. 1999 Dec;46(6):901-9. doi: 10.1002/1531-8249(199912)46:63.0.co;2-7.
PubMed 10589543Calautti C, Leroy F, Guincestre JY, Baron JC. Dynamics of motor network overactivation after striatocapsular stroke: a longitudinal PET study using a fixed-performance paradigm. Stroke. 2001 Nov;32(11):2534-42. doi: 10.1161/hs1101.097401.
PubMed 11692013Marshall RS, Perera GM, Lazar RM, Krakauer JW, Constantine RC, DeLaPaz RL. Evolution of cortical activation during recovery from corticospinal tract infarction. Stroke. 2000 Mar;31(3):656-61. doi: 10.1161/01.str.31.3.656.
PubMed 10700500Taub E, Miller NE, Novack TA, Cook EW 3rd, Fleming WC, Nepomuceno CS, Connell JS, Crago JE. Technique to improve chronic motor deficit after stroke. Arch Phys Med Rehabil. 1993 Apr;74(4):347-54.
PubMed 8466415Liepert J, Bauder H, Wolfgang HR, Miltner WH, Taub E, Weiller C. Treatment-induced cortical reorganization after stroke in humans. Stroke. 2000 Jun;31(6):1210-6. doi: 10.1161/01.str.31.6.1210.
PubMed 10835434Rouiller EM, Yu XH, Moret V, Tempini A, Wiesendanger M, Liang F. Dexterity in adult monkeys following early lesion of the motor cortical hand area: the role of cortex adjacent to the lesion. Eur J Neurosci. 1998 Feb;10(2):729-40. doi: 10.1046/j.1460-9568.1998.00075.x.
PubMed 9749734Nudo RJ, Milliken GW. Reorganization of movement representations in primary motor cortex following focal ischemic infarcts in adult squirrel monkeys. J Neurophysiol. 1996 May;75(5):2144-9. doi: 10.1152/jn.1996.75.5.2144.
PubMed 8734610Brasil-Neto JP, Valls-Sole J, Pascual-Leone A, Cammarota A, Amassian VE, Cracco R, Maccabee P, Cracco J, Hallett M, Cohen LG. Rapid modulation of human cortical motor outputs following ischaemic nerve block. Brain. 1993 Jun;116 ( Pt 3):511-25. doi: 10.1093/brain/116.3.511.
PubMed 8513390
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortex Motor Function Reorganization in Stroke Patients: A Longitudinal fMRI Study
- ClinicalTrials.gov ID
- NCT04794673
- Acronym / sponsor ID
- LY-81825105
- Conditions
- Ischemic Stroke
- Keywords
- motor cortex reorganization, Ischemic Stroke, fMRI, BOLD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military CommandUniversity, hospital or other
- Study start
- 12 Jan 2020 (actual)
- Primary completion
- 12 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 12 Mar 2021 (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.
In China, stroke is among the highest morbidity and mortality, especially in senile population. Most of those patients had survived with various degrees of cerebral dysfunction; among them about 50% were motor deficit. Previous in vitro studies indicated that recovery of motor function after stroke were related not only to axonal regeneration or synapse reformation, but also functional reorganization of adjacent areas and other functional associated areas. The previous fMRI studies shown that the cerebral motor cortex possess the natural ability of self compensation and self reorganization in the situation of brain damage. It was characterized by equally bilateral activation in acute stage to partial ipsilateral activation and major contralateral activation in subacute stage to contralateral activation in chronic stage.
We plan to recruit first-episode acute cerebral infarction patients with single lesion on middle cerebral artery supply area and age and sex matched healthy volunteers. All the patients are going to assess in three different sessions (V1, 3 days after the onset of complaint, V2,30 days after onset of complaint; V3, 90 days after onset of the complaint ) with both clinical check as well as fMRI scan. The clinical assessment including dynamometer and finger tapping test to evaluate the strength and the flexibility of each upper legs and it also included the corresponding scales to exclude poststroke dementia and moderate and serious poststroke depression. The fMRI is scanned by using bilateral arm motor tasks. Motor cortex activation regions, activation of voxel between healthy controls and patients in different checkpoint are collected.
The purpose of this study is to investigate the dynamic process of motor cortical functional reorganization after cerebral stoke using functional magnetic resonance imaging combined with the behavior assessment. Meanwhile，we also studied the differences of motor function recovery and motor cortex compensation between dominant hemisphere and non-dominant hemisphere after stroke. Therefore, we could provide a theoretical basis and build up a useful evaluation system for rehabilitation after stroke and other arious cerebral injury.
Detailed description
The cases derive from patients with acute ischemic stroke hospitalized in Neurology Department General Hospital of Guangzhou Military Command of PLA. The diagnosis of ischemic stroke is diagnosed using the diagnostic criteria of the International Association of Neurological Diseases and Stroke Association in 1982. The classification criteria for ischemic stroke are 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 of PLA, and all patients or their guardian sign informed consent. According to the location and diagnostic criteria, the patients are divided into three groups: left hemisphere infarction patients group, right hemisphere infarction patients group and normal healthy control group. The subjects performed index finger tapping test, the maximum hand grip strength test of both hands, National Institute of Health stroke scale(NIHSS), Barthel Index(BI), Hamilton Anxiety Scale(HAMA), Hamilton Anxiety Scale(HAMA) and functional magnetic resonance (fMRI) tests at 3 days (V1), 30 days (V2) and 90 days (V3 phase) after the onset of cerebral infarction. In the healthy control group, the above examination is performed only 1 times. All subjects are assessed for clinical behavior by an independent third party.
Task-state function magnetic resonance design: Using the block design. There are two sequences. One sequence is in the way of rest and left hand movement, then repeat 5 times, ending at rest. The other is in the way of rest and right hand movement, then repeat 5 times, ending at rest. Each sequence lasted 220s, and the total duration of all tests was 440s. At the hand movement stage, each participant is at 1HZ Rhythm for the clenched fist movement with maximum strength, keep their whole body relaxed at the resting phase, with wrist and fingers not moving. participants use visual information to strictly control time and frequency of movement. Visual information is written by DMDX software, and accept the work instruction then sent to a transparent screen via a computer projector. Participants observed the information through a reflector mounted on a head coil.
Magnetic resonance data acquisition: 1.5 Tesla superconducting magnetic resonance scanner of Siemens Sonata company is applied. The standard phased array head coil is the radio frequency coil. Gradient field is 40m T/m, and switching rate is 200m T/m/ms. The scanning sequence and parameters are as follows:(1) T1 WI scan, obtaining whole brain structure image data: repeat time is 683ms, echo time is 11ms, layer thickness is 4mm, layer spacing is 1mm, matrix is 192x144, field of vision is 230mmx230mm, a total of 28 layers, range including whole brain. (2) The blood oxygen level dependent signal of the motor task state and resting state functional magnetic resonance imaging: using gradient echo combined with single excitation echo plane Imaging technology, the parameters are as follows: repeat time is 2000ms, echo time is 49ms, layer thickness is 4mm, layer spacing is 1mm, matrix is 64x64, field of vision is 210mmx210mm, a total of 28 layers.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Left damage | – | Other: brain damageHave the brain damage and the location of the damage in the left brain |
| Right damage | – | Other: brain damageHave the brain damage and the location of the damage in the right brain |
| Nomal control | – | Other: brain damageNot have the brain damage |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We plan to recruite first-episode acute cerebral infarction patients with single lesion on middle cerebral artery supply area and age and sex matched healthy volunteers.
Key inclusion criteria (8 listed)
- The first onset, the lesion was the single lesion of infarction or hemorrhage confirmed by head Magnetic Resonance Imaging(MRI) or Computed Tomography(CT).
- Hemiplegic hand muscle strength above grade 3, and was able to cooperate with the stimulation task of f MRI examination.
- According to the Edinburgh Handedness Questionnaire (EHQ) as the right hand.
- According to the commonly used eye chart examination, the naked eye vision >4.9.
- There is no central nervous system organic disease and other motor diseases that can affect hand function.
Key exclusion criteria (11 listed)
- Previous diseases of the central nervous system and peripheral nervous system that significantly affected the motor function of limbs.
- Significant cognitive impairment, MMSE≤27.
- Subjects was engaged in professional music playing or keyboard operation before illness.
- The level of consciousness drops after the illness.
- Significant anxiety and depression status (Hamilton anxiety scale ≥14 points, Hamilton depression scale ≥13 points) and other mental illness and history.
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 |
|---|---|---|
| brain damageHave or not have the brain damage and the location of the damage | Other | Left damage, Nomal control, Right damage |
Primary outcome
A change of outcome measure: Index finger tapping test
Time frame: This is an outcome measure to assess the improvement of motor function from onset to 3 months after treatment. Thus, participates will undergo this assessment on the 3 days (V1), 30 days (V2), and 90 days (V3) after randomization.
The primary measure is the number of clicks that one index finger makes on the mouse as quickly as possible in 10 seconds.The subject took a sitting position and tapped the mouse with his index finger to record the fastest number of taps within 10 seconds.
A change of outcome measure: The maximum hand grip strength test
Time frame: This is an outcome measure to assess the improvement of motor function from onset to 3 months after treatment. Thus, participates will undergo this assessment on the 3 days (V1), 30days (V2), and 90 days (V3) after randomization.
Grip dynamometer(Beijing xintong sport equipment co. LTD, WCS-99.9 digital display electric the child dynamometer), in kilograms. To facilitate the maximum grip strength of one hand, the patient may place the arm in any position during the measurement, no body contact, elbows may be flexed or extended.
5 secondary outcomes
A change of outcome measure: Functional Magnetic Resonance Imaging(fMRI)
Time frame: We must determine that the participant is not in moderate or more cognitive impairment at each follow-up. Thus, participates will undergo this assessment on the 3 days (V1), 30 days (V2), and 90 days (V3) after randomization.
National Institute of Health stroke scale(NIHSS )
Time frame: In order to ensure that participants can cooperate with our study, this assessment will be performed before randomization.
Follow-up measurement: Hamilton Depression Rating Scale (HAMD)
Time frame: We must determine that the participant is not in depression at each follow-up. Thus, participates will undergo this assessment on the 3 days (V1), 30 days (V2), and 90 days (V3) after randomization.
Follow-up measurement: Hamilton Anxiety Rating Scale (HAMA)
Time frame: We must determine that the participant is not in anxiety at each follow-up. Thus, participates will undergo this assessment on the 3 days (V1), 30 days (V2), and 90 days (V3) after randomization.
Follow-up measurement: Mini-Mental State Examination (MMSE)
Time frame: We must determine that the participant is not in moderate or more cognitive impairment at each follow-up. Thus, participates will undergo this assessment on the 3 days (V1), 30 days (V2), and 90 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 12 Mar 2021.
- Background: PubMed 15623682Brown DL, Lisabeth LD, Garcia NM, Smith MA, Morgenstern LB. Emergency department evaluation of ischemic stroke and TIA: the BASIC Project. Neurology. 2004 Dec 28;63(12):2250-4. doi: 10.1212/01.wnl.0000147292.64051.9b.
- Background: PubMed 19737873Kokotilo KJ, Eng JJ, McKeown MJ, Boyd LA. Greater activation of secondary motor areas is related to less arm use after stroke. Neurorehabil Neural Repair. 2010 Jan;24(1):78-87. doi: 10.1177/1545968309345269. Epub 2009 Sep 8.
- Background: PubMed 18234688Swayne OB, Rothwell JC, Ward NS, Greenwood RJ. Stages of motor output reorganization after hemispheric stroke suggested by longitudinal studies of cortical physiology. Cereb Cortex. 2008 Aug;18(8):1909-22. doi: 10.1093/cercor/bhm218. Epub 2008 Jan 29.
- Background: PubMed 17481399O'Shea J, Johansen-Berg H, Trief D, Gobel S, Rushworth MF. Functionally specific reorganization in human premotor cortex. Neuron. 2007 May 3;54(3):479-90. doi: 10.1016/j.neuron.2007.04.021.
- Background: PubMed 16738254Lotze M, Markert J, Sauseng P, Hoppe J, Plewnia C, Gerloff C. The role of multiple contralesional motor areas for complex hand movements after internal capsular lesion. J Neurosci. 2006 May 31;26(22):6096-102. doi: 10.1523/JNEUROSCI.4564-05.2006.
- Background: PubMed 9412643Cramer SC, Nelles G, Benson RR, Kaplan JD, Parker RA, Kwong KK, Kennedy DN, Finklestein SP, Rosen BR. A functional MRI study of subjects recovered from hemiparetic stroke. Stroke. 1997 Dec;28(12):2518-27. doi: 10.1161/01.str.28.12.2518.
- Background: PubMed 15029909Rossini PM, Dal Forno G. Integrated technology for evaluation of brain function and neural plasticity. Phys Med Rehabil Clin N Am. 2004 Feb;15(1):263-306. doi: 10.1016/s1047-9651(03)00124-4.
- Background: PubMed 10589543Nelles G, Spiekramann G, Jueptner M, Leonhardt G, Muller S, Gerhard H, Diener HC. Evolution of functional reorganization in hemiplegic stroke: a serial positron emission tomographic activation study. Ann Neurol. 1999 Dec;46(6):901-9. doi: 10.1002/1531-8249(199912)46:63.0.co;2-7.
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- Individual participant dataSharing planned: Undecided
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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.
Yan LIU, PhD study chair
Guangzhou General 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 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 8 inclusion and 11 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 12 Mar 2021. 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: Index finger tapping test (time frame: This is an outcome measure to assess the improvement of motor function from onset to 3 months after treatment. Thus, participates will undergo this assessment on the 3 days (V1), 30 days (V2), and 90 days (V3) after randomization.). The study lists 2 primary outcomes in all. 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 NCT04794673, which also lists 31 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 12 Mar 2021.