Stroke
Conditions
Keywords
Ischemic stroke, Functional magnetic resonance imaging (fMRI), Repetitive transcranial magnetic stimulation (rTMS), Brain Reorganization
Brief summary
The study aimed to figure out brain structural and functional reorganization evidence after repetitive transcranial magnetic stimulation through the method of neuroimaging brain network analysis, such as resting-state functional magnetic resonance imaging and diffusion tensor imaging.
Interventions
The rTMS treatments were performed using a Medtronic MagPro type magnetic stimulation device (Medtronic, Minneapolis, MN, USA) and a figure-of-eight coil (MC-B70, Medtronic). Coils were placed tangent to the scalp. The stimulation protocol involved 50 trains of 20 pulses applied over the ipsilesional M1 at a frequency of 5 HZ, with the stimulus intensity set at 120% of the resting motor threshold of the unaffected extremity.
DEVICEsham Repetitive Transcranial Magnetic Stimulation
The sham rTMS was performed on the same site as the rTMS treatment group but without any true stimulations. Coils were placed perpendicular to the scalp.
Sponsors
Chinese Academy of Sciences
University of Pennsylvania
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. stroke patients within 1 week after onset with unilateral cerebral subcortex lesion in the middle cerebral artery territory detected by diffusion weighted image, 2. right-handed, 3. without memory loss or intelligence disorder, 4. never suffered stroke before.
Exclusion criteria
1. direct damage to the cerebral cortex, 2. a history of cerebral vessel disease, 3. tendency to hemorrhage or existed brain hemorrhage, 4. epilepsy or other mental disorders, 5. any MRI contraindications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| National Institutes of Health Stroke Scale (NIHSS) | Change from Baseline NIHSS at 1 month after real rTMS/sham rTMS | The investigators use National Institutes of Health Stroke Scale (NIHSS) to evaluate the participants' neural deficit after 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. Higher NIHSS scores mean a worse outcome. |
| Barthel Index (BI) | Change from Baseline BI at 1 month after real rTMS/sham rTMS | The investigators use Barthel Index (BI) to evaluate the participants' activities of daily living after stroke. The BI consists of 10 questions that relate to degree of independence with activities of daily living, including toileting, bathing, eating, dressing, continence, transfers, and ambulation. The BI score is calculated by summing the response value to each of the 10 questions. The BI score ranges from 0 to 100. A patient scoring 0 points would be dependent in all assessed activities of daily living, whereas a score of 100 would reflect independence in these activities. A higher score is associated with a better outcome. |
| Fugl-Meyer Assessment Upper Limb (FMA-UL) | Change from Baseline FMA at 1 month after real rTMS/sham rTMS | The investigators use Fugl-Meyer assessment Upper Limb (FMA-UL) to evaluate the participants' motor function of upper limb. The FMA-UL is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. The maximum score of FMA-UL is 66 and the minimum score is 0. Higher scores mean a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Connectivity Map (FC Map) | Change from Baseline z-FC maps at 1 month after real rTMS/sham rTMS | Functional Connectivity was examined using a seed-based voxel-wise correlation approach. The ipsilesional primary motor cortex (M1) was defined as the region of interest. Pearson's correlation analysis between the time course of the ipsilesional M1 and that of every voxel in the whole brain was computed for a map of correlation coefficients, which were Fisher's z-transformed and called as z-FC maps. |
Countries
China
Participant flow
Recruitment details
Acute ischemic stroke inpatients from the department of Neurology in Peking Union Medical College Hospital were enrolled.
Pre-assignment details
Ten participants were excluded from the study because they didn't meet the inclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| rTMS Treatment Group The rTMS treatment group received a 10-day real repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.
real Repetitive Transcranial Magnetic Stimulation: The rTMS treatments were performed using a Medtronic MagPro type magnetic stimulation device (Medtronic, Minneapolis, MN, USA) and a figure-of-eight coil (MC-B70, Medtronic). Coils were placed tangent to the scalp. The stimulation protocol involved 50 trains of 20 pulses applied over the ipsilesional M1 at a frequency of 5 HZ, with the stimulus intensity set at 120% of the resting motor threshold of the unaffected extremity. | 21 |
| Sham Group The sham group received a 10-day sham repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.
sham Repetitive Transcranial Magnetic Stimulation: The sham rTMS was performed on the same site as the rTMS treatment group but without any true stimulations. Coils were placed perpendicular to the scalp. | 21 |
| Total | 42 |
Baseline characteristics
| Characteristic | rTMS Treatment Group | Total | Sham Group |
|---|---|---|---|
| Age, Continuous | 59.7 years STANDARD_DEVIATION 6.8 | 58.5 years STANDARD_DEVIATION 11.1 | 57.4 years STANDARD_DEVIATION 14 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 21 Participants | 42 Participants | 21 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 21 participants | 42 participants | 21 participants |
| Sex: Female, Male Female | 5 Participants | 12 Participants | 7 Participants |
| Sex: Female, Male Male | 16 Participants | 30 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 21 |
| other Total, other adverse events | 2 / 21 | 2 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 |
Outcome results
Primary
Barthel Index (BI)
The investigators use Barthel Index (BI) to evaluate the participants' activities of daily living after stroke. The BI consists of 10 questions that relate to degree of independence with activities of daily living, including toileting, bathing, eating, dressing, continence, transfers, and ambulation. The BI score is calculated by summing the response value to each of the 10 questions. The BI score ranges from 0 to 100. A patient scoring 0 points would be dependent in all assessed activities of daily living, whereas a score of 100 would reflect independence in these activities. A higher score is associated with a better outcome.
Time frame: Change from Baseline BI at 1 month after real rTMS/sham rTMS
Population: Two patients lost in the follow-up of the rTMS treatment group. And three patients lost in the follow-up of the sham group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rTMS Treatment Group | Barthel Index (BI) | 22.6 score on a scale | Standard Deviation 6.5 |
| Sham Group | Barthel Index (BI) | 17.8 score on a scale | Standard Deviation 6.9 |
Primary
Fugl-Meyer Assessment Upper Limb (FMA-UL)
The investigators use Fugl-Meyer assessment Upper Limb (FMA-UL) to evaluate the participants' motor function of upper limb. The FMA-UL is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. The maximum score of FMA-UL is 66 and the minimum score is 0. Higher scores mean a better outcome.
Time frame: Change from Baseline FMA at 1 month after real rTMS/sham rTMS
Population: Two patients lost in the follow-up of the rTMS treatment group. And three patients lost in the follow-up of the sham group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rTMS Treatment Group | Fugl-Meyer Assessment Upper Limb (FMA-UL) | 14.9 score on a scale | Standard Deviation 4.4 |
| Sham Group | Fugl-Meyer Assessment Upper Limb (FMA-UL) | 11.1 score on a scale | Standard Deviation 3.8 |
Primary
National Institutes of Health Stroke Scale (NIHSS)
The investigators use National Institutes of Health Stroke Scale (NIHSS) to evaluate the participants' neural deficit after 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. Higher NIHSS scores mean a worse outcome.
Time frame: Change from Baseline NIHSS at 1 month after real rTMS/sham rTMS
Population: Two patients lost in the follow-up of the rTMS treatment group. And three patients lost in the follow-up of the sham group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rTMS Treatment Group | National Institutes of Health Stroke Scale (NIHSS) | 3.8 score on a scale | Standard Deviation 1.8 |
| Sham Group | National Institutes of Health Stroke Scale (NIHSS) | 2.7 score on a scale | Standard Deviation 0.6 |
Secondary
Functional Connectivity Map (FC Map)
Functional Connectivity was examined using a seed-based voxel-wise correlation approach. The ipsilesional primary motor cortex (M1) was defined as the region of interest. Pearson's correlation analysis between the time course of the ipsilesional M1 and that of every voxel in the whole brain was computed for a map of correlation coefficients, which were Fisher's z-transformed and called as z-FC maps.
Time frame: Change from Baseline z-FC maps at 1 month after real rTMS/sham rTMS
Population: This outcome measurement, the z-FC map, is not numeric data. Z-FC map is a radiographic imaging measurement. The study compared the difference of the z-FC map between the rTMS treatment group and the sham group.