Motor NeuropathyEEG-fMRINCT05427422
Stroke Recovery Research Based on EEG-fMRI
An observational study of Motor Neuropathy, run by Xi'an Jiaotong University at 1 site in China.
Trial summary
This study is aimed to investigate the post-stroke motor recovery of patients with ischemic stroke based on their neural features extracted from EEG-fMRI data. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Neuropathy
- What is being tested?
- MRI recording and EEG recording
- Type of treatment
- Injection or infusion
- How many people
- 147 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2022to 30 Jan 2024
- 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: AA population with motor impairment induced by first-ever stroke in a specific duration (7-14 days after stroke attack, i.e., early subacute stage) would be enrolled to investigate the mechanisms of post-stroke recovery of motor function.
Who may be able to join
- Age above 18 and below 75 years
- Motor impairment in National Institutes of Health Stroke Scale
- 7-14 days since stroke attack
- First-ever ischemic stroke
Who cannot join
- Motor impairment induced by non-stroke aetiology
- Claustrophobia; recognition disorder
- History of other severe central nervous system diseases
- Any signs unfit for MRI/EEG scan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motor Recovery of Stroke Patients Based on Electroencephalogram-functional Magnetic Resonance Imaging
This study is aimed to investigate the post-stroke motor recovery of patients with ischemic stroke based on their neural features extracted from EEG-fMRI data.
Read the detailed description
A group of patients with ischemic stroke and age/gender matched healthy controls would be enrolled in this study. Their features of neural activities based on EEG-fMRI fusion scan would be extracted to investigate the mechanisms of motor recovery after stroke. Particularly, the correlations of their features of neural networks or local activities to their motor function (defined as their Fugl-Meyer scores) at enrollment and their recovery time courses consisted of Fugl-Meyer scores in follow-up time points. Data of T1 structural, DSI fiber image and pure EEG (without MRI) would also be collected along with EEG-fMRI fusion data.
- Conditions
- Motor Neuropathy
- Being tested
- MRI recording, EEG recording
- Keywords
- motor function recovery, ischemic stroke, EEG-fMRI, neural plasticity
- Medical subject headings
- Neuritis, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI recordingDiagnostic test
MRI imaging was performed using a 3 Tesla Siemens Prisma system with a 64-channel head/neck coil (Siemens Medical Systems, Erlangen, Germany). The MRI protocols included as follows: (i) Magnetization-Prepared 2 Rapid Acquisition Gradient Echoes: TR/TE/ TI1/TI2 = 5000/2.98/700/2500 ms, voxel size = 1.0 × 1.0 × 1.0 mm3, FOV = 256 × 240 × 176 mm3; (ii)Gradient-echo EPI: TR 720 ms, TE 33.1 ms, flip angle 52 deg, FOV 208x180 mm, Matrix 104x90, Slice thickness 2.0 mm; 72 slices; 2.0 mm isotropic voxels, Multiband factor 8, Echo spacing 0.58 ms, BW 2290 Hz/Px; (iii) DSI : TR/TE = 3300/73 ms, FOV = 220 × 220 × 60 mm3, voxel size = 2 × 2 × 2 mm3, 128 diffusion direction, b-max = 3000 sec/mm2, AT = 7:22 min); (iv) T2-weighted fluid-attenuated inversion recovery: TR/TE = 9000/84 ms, FOV = 270 × 320 × 22 mm2, voxel size = 0.72 × 0.72 × 6.6 mm3.
EEG recordingDiagnostic test
EEG was performed using a BrainAmp MR 32 amplifier (BrainProducts GmbH, München, Germany). The EEG protocols included as follows: (i) EEG-fMRI fusion: Sampling rate: 5000 Hz, low cut off-high cut off: DC-1000Hz;(2) EEG-fMRI fusion: Sampling rate: 1000 Hz, low cut off-high cut off: DC-1000Hz.
In (i) an ECG channel would be used to collect artifact of pulse and not used in (ii).
| Study group | Role | What they receive |
|---|---|---|
| High Recovery | Effective recovery rate defined as difference between Fugl-meyer scores in the 6 weeks after stroke onset (eF) and in the enrollment (sF) normalized by (total score-sf) would be used to indicate the recovery Level of a patients, i.e., (eF-sF)/ (total score-sf). A previously reported recovery rate, i.e., proportional recovery((eF-sF)/(total score-sf)=0.7) was chosen as a standard of a high recovery. Patients with effective recovery rate higher than 0.7 at the T1 time point (6 weeks after stroke onset) would be assigned to group with high recovery rate Receives: Diagnostic Test: MRI recording; Diagnostic Test: EEG recording | |
| Low Recovery | The Low Recovery group indicates that patients with effective recovery rate lower than 0.7 Receives: Diagnostic Test: MRI recording; Diagnostic Test: EEG recording | |
| Healthy Control | Age/sex matched healthy subjects enrolled to compare with group of patients. Receives: Diagnostic Test: MRI recording; Diagnostic Test: EEG recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer scores (T0)
a scale widely used to evaluate one's motor impairment
Measured: 7-14 days since stroke
Fugl-Meyer scores (T1)
a scale widely used to evaluate one's motor impairment
Measured: 6 weeks since stroke
Fugl-Meyer scores (T2)
a scale widely used to evaluate one's motor impairment
Measured: 12 weeks since stroke
Fugl-Meyer scores (T3)
a scale widely used to evaluate one's motor impairment
Measured: 72 weeks since stroke
Secondary outcomes (4)
Neuroimage features based on EEG-fMRI (T0)
Neuroimage features extracted from EEG-fMRI data
Measured: 7-14 days since stroke
Neuroimage features based on EEG-fMRI (T1)
Neuroimage features extracted from EEG-fMRI data
Measured: 6 weeks since stroke
Neuroimage features based on EEG-fMRI (T2)
Neuroimage features extracted from EEG-fMRI data
Measured: 12 weeks since stroke
Neuroimage features based on EEG-fMRI (T3)
Neuroimage features extracted from EEG-fMRI data
Measured: 72 weeks since stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start30 Jun 2022
- Primary completion30 Dec 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor NeuropathyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Collaborators
- Xian Daxing Hospital
- Responsible party
- Principal investigator, Wentao Zeng, Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427422
- Sponsor's protocol ID
- Stroke01
- Acronym
- EEG-fMRI
- Status last verified
- Sep 2024
- First submitted
- 14 Jun 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Recovery of Stroke Patients Based on Electroencephalogram-functional Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT05427422
- Acronym / sponsor ID
- EEG-fMRI / Stroke01
- Conditions
- Motor Neuropathy
- Keywords
- motor function recovery, ischemic stroke, EEG-fMRI, neural plasticity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Xian Daxing Hospital
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 22 Jun 2022 (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.
This study is aimed to investigate the post-stroke motor recovery of patients with ischemic stroke based on their neural features extracted from EEG-fMRI data.
Detailed description
A group of patients with ischemic stroke and age/gender matched healthy controls would be enrolled in this study. Their features of neural activities based on EEG-fMRI fusion scan would be extracted to investigate the mechanisms of motor recovery after stroke. Particularly, the correlations of their features of neural networks or local activities to their motor function (defined as their Fugl-Meyer scores) at enrollment and their recovery time courses consisted of Fugl-Meyer scores in follow-up time points. Data of T1 structural, DSI fiber image and pure EEG (without MRI) would also be collected along with EEG-fMRI fusion data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Recovery | – | Diagnostic Test: MRI recording, Diagnostic Test: EEG recordingEffective recovery rate defined as difference between Fugl-meyer scores in the 6 weeks after stroke onset (eF) and in the enrollment (sF) normalized by (total score-sf) would be used to indicate the recovery Level of a patients, i.e., (eF-sF)/ (total score-sf). A previously reported recovery rate, i.e., proportional recovery((eF-sF)/(total score-sf)=0.7) was chosen as a standard of a high recovery. Patients with effective recovery rate higher than 0.7 at the T1 time point (6 weeks after stroke onset) would be assigned to group with high recovery rate |
| Low Recovery | – | Diagnostic Test: MRI recording, Diagnostic Test: EEG recordingThe Low Recovery group indicates that patients with effective recovery rate lower than 0.7 |
| Healthy Control | – | Diagnostic Test: MRI recording, Diagnostic Test: EEG recordingAge/sex matched healthy subjects enrolled to compare with group of patients. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- AA population with motor impairment induced by first-ever stroke in a specific duration (7-14 days after stroke attack, i.e., early subacute stage) would be enrolled to investigate the mechanisms of post-stroke recovery of motor function.
Key inclusion criteria (4 listed)
- Age above 18 and below 75 years
- Motor impairment in National Institutes of Health Stroke Scale
- 7-14 days since stroke attack
- First-ever ischemic stroke
Key exclusion criteria (4 listed)
- Motor impairment induced by non-stroke aetiology
- Claustrophobia; recognition disorder
- History of other severe central nervous system diseases
- Any signs unfit for MRI/EEG scan
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 |
|---|---|---|
| MRI recordingMRI imaging was performed using a 3 Tesla Siemens Prisma system with a 64-channel head/neck coil (Siemens Medical Systems, Erlangen, Germany). The MRI protocols included as follows: (i) Magnetization-Prepared 2 Rapid Acquisition Gradient Echoes: TR/TE/ TI1/TI2 = 5000/2.98/700/2500 ms, voxel size = 1.0 × 1.0 × 1.0 mm3, FOV = 256 × 240 × 176 mm3; (ii)Gradient-echo EPI: TR 720 ms, TE 33.1 ms, flip angle 52 deg, FOV 208x180 mm, Matrix 104x90, Slice thickness 2.0 mm; 72 slices; 2.0 mm isotropic voxels, Multiband factor 8, Echo spacing 0.58 ms, BW 2290 Hz/Px; (iii) DSI : TR/TE = 3300/73 ms, FOV = 220 × 220 × 60 mm3, voxel size = 2 × 2 × 2 mm3, 128 diffusion direction, b-max = 3000 sec/mm2, AT = 7:22 min); (iv) T2-weighted fluid-attenuated inversion recovery: TR/TE = 9000/84 ms, FOV = 270 × 320 × 22 mm2, voxel size = 0.72 × 0.72 × 6.6 mm3. | Diagnostic test | Healthy Control, High Recovery, Low Recovery |
| EEG recordingEEG was performed using a BrainAmp MR 32 amplifier (BrainProducts GmbH, München, Germany). The EEG protocols included as follows: (i) EEG-fMRI fusion: Sampling rate: 5000 Hz, low cut off-high cut off: DC-1000Hz;(2) EEG-fMRI fusion: Sampling rate: 1000 Hz, low cut off-high cut off: DC-1000Hz. In (i) an ECG channel would be used to collect artifact of pulse and not used in (ii). | Diagnostic test | Healthy Control, High Recovery, Low Recovery |
Primary outcome
Fugl-Meyer scores (T0)
Time frame: 7-14 days since stroke
a scale widely used to evaluate one's motor impairment
Fugl-Meyer scores (T1)
Time frame: 6 weeks since stroke
a scale widely used to evaluate one's motor impairment
Fugl-Meyer scores (T2)
Time frame: 12 weeks since stroke
a scale widely used to evaluate one's motor impairment
Fugl-Meyer scores (T3)
Time frame: 72 weeks since stroke
a scale widely used to evaluate one's motor impairment
4 secondary outcomes
Neuroimage features based on EEG-fMRI (T0)
Time frame: 7-14 days since stroke
Neuroimage features based on EEG-fMRI (T1)
Time frame: 6 weeks since stroke
Neuroimage features based on EEG-fMRI (T2)
Time frame: 12 weeks since stroke
Neuroimage features based on EEG-fMRI (T3)
Time frame: 72 weeks since stroke
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 19 Sep 2024.
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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 Motor Neuropathy, run by Xi'an Jiaotong University 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 4 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 19 Sep 2024. 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?
Fugl-Meyer scores (T0) (time frame: 7-14 days since stroke). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.