Trial Outcomes & Findings for Cerebral Reorganization of Stroke Patients After Repetitive Transcranial Magnetic Stimulation by Neuroimaging Analysis (NCT NCT03163758)

Last Updated: 2020-06-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

52 participants

Primary outcome timeframe

Change from Baseline NIHSS at 1 month after real rTMS/sham rTMS

Results posted on

2020-06-30

Participant Flow

Acute ischemic stroke inpatients from the department of Neurology in Peking Union Medical College Hospital were enrolled.

Ten participants were excluded from the study because they didn't meet the inclusion criteria.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	21	21
Overall Study COMPLETED	13	14
Overall Study NOT COMPLETED	8	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cerebral Reorganization of Stroke Patients After Repetitive Transcranial Magnetic Stimulation by Neuroimaging Analysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	rTMS Treatment Group n=21 Participants 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.	Sham Group n=21 Participants 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.	Total n=42 Participants Total of all reporting groups
Age, Continuous	59.7 years STANDARD_DEVIATION 6.8 • n=5 Participants	57.4 years STANDARD_DEVIATION 14.0 • n=7 Participants	58.5 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment China	21 participants n=5 Participants	21 participants n=7 Participants	42 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	rTMS Treatment Group n=19 Participants 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.	Sham Group n=18 Participants 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.
National Institutes of Health Stroke Scale (NIHSS)	3.8 score on a scale Standard Deviation 1.8	2.7 score on a scale Standard Deviation 0.6

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	rTMS Treatment Group n=19 Participants 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.	Sham Group n=18 Participants 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.
Barthel Index (BI)	22.6 score on a scale Standard Deviation 6.5	17.8 score on a scale Standard Deviation 6.9

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	rTMS Treatment Group n=19 Participants 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.	Sham Group n=18 Participants 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.
Fugl-Meyer Assessment Upper Limb (FMA-UL)	14.9 score on a scale Standard Deviation 4.4	11.1 score on a scale Standard Deviation 3.8

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

rTMS Treatment Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Sham Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	rTMS Treatment Group n=21 participants at risk 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.	Sham Group n=21 participants at risk 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.
Nervous system disorders headache	4.8% 1/21 • Number of events 1 • one month after real/sham rTMS treatment The common adverse events of rTMS are headache, dizzy, scalp discomfort at the site of stimulation, tingling, spasms or twitching of facial muscles and lightheadedness. The uncommon side effects of rTMS include seizures, mania, and hearing loss.	4.8% 1/21 • Number of events 1 • one month after real/sham rTMS treatment The common adverse events of rTMS are headache, dizzy, scalp discomfort at the site of stimulation, tingling, spasms or twitching of facial muscles and lightheadedness. The uncommon side effects of rTMS include seizures, mania, and hearing loss.
Nervous system disorders dizzy	4.8% 1/21 • Number of events 1 • one month after real/sham rTMS treatment The common adverse events of rTMS are headache, dizzy, scalp discomfort at the site of stimulation, tingling, spasms or twitching of facial muscles and lightheadedness. The uncommon side effects of rTMS include seizures, mania, and hearing loss.	4.8% 1/21 • Number of events 1 • one month after real/sham rTMS treatment The common adverse events of rTMS are headache, dizzy, scalp discomfort at the site of stimulation, tingling, spasms or twitching of facial muscles and lightheadedness. The uncommon side effects of rTMS include seizures, mania, and hearing loss.

Additional Information

Dr. Weihong Zhang

Peking Union Medical College Hospital

Phone: 01069159581

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place