Trial Outcomes & Findings for Repetitive Transcranial Magnetic Stimulation Use in Acute Stroke (NCT NCT01922986)
NCT ID: NCT01922986
Last Updated: 2017-05-25
Results Overview
This test quantifies the time it takes for the subject to do the following standardized functional tasks with the hand: stack three checkers, turn over cards, turn over empty cans, turn over fluid-filled cans, pick up and place small items like a paper clip, etc into a can, and use a spoon to scoop up a bean and drop the bean into a can. The unit of measure is time and changes that are negative signify reduced time at posttest compared to pretest, which would be an improvement. Total score = sum of times for each subtests
COMPLETED
NA
4 participants
Measured at pretest (day before treatments begin) and posttest (day following last treatment). Thus, 7 days of participation (1 pretest, 5 treatments, 1 posttest).
2017-05-25
Participant Flow
Participant milestones
| Measure |
Active rTMS With Conventional Therapy
20 minutes of active rTMS followed by conventional stroke therapy
active rTMS: 10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).
conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training
|
Sham rTMS With Conventional Therapy
20 minutes of sham rTMS stimulation followed by conventional stroke therapy
sham rTMS: 20 minutes of sham rTMS stimulation
conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Repetitive Transcranial Magnetic Stimulation Use in Acute Stroke
Baseline characteristics by cohort
| Measure |
Active rTMS With Conventional Therapy
n=2 Participants
20 minutes of active rTMS followed by conventional stroke therapy
active rTMS: 10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).
conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training
|
Sham rTMS With Conventional Therapy
n=2 Participants
20 minutes of sham rTMS stimulation followed by conventional stroke therapy
sham rTMS: 20 minutes of sham rTMS stimulation
conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
73.5 years
STANDARD_DEVIATION 19.1 • n=5 Participants
|
52.5 years
STANDARD_DEVIATION 23.3 • n=7 Participants
|
63.0 years
STANDARD_DEVIATION 21.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 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
United States
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at pretest (day before treatments begin) and posttest (day following last treatment). Thus, 7 days of participation (1 pretest, 5 treatments, 1 posttest).This test quantifies the time it takes for the subject to do the following standardized functional tasks with the hand: stack three checkers, turn over cards, turn over empty cans, turn over fluid-filled cans, pick up and place small items like a paper clip, etc into a can, and use a spoon to scoop up a bean and drop the bean into a can. The unit of measure is time and changes that are negative signify reduced time at posttest compared to pretest, which would be an improvement. Total score = sum of times for each subtests
Outcome measures
| Measure |
Active rTMS With Conventional Therapy
n=2 Participants
20 minutes of active rTMS followed by conventional stroke therapy
active rTMS: 10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).
conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training
|
Sham rTMS With Conventional Therapy
n=2 Participants
20 minutes of sham rTMS stimulation followed by conventional stroke therapy
sham rTMS: 20 minutes of sham rTMS stimulation
conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training
|
|---|---|---|
|
Percent Change From Baseline in Jebsen Taylor Hand Function Test Scores
|
-23.0 percentage of change from baseline
Standard Deviation 32.5
|
0 percentage of change from baseline
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Measured at pretest (day before treatments begin) and posttest (day following last treatment). Thus, 7 days of participation (1 pretest, 5 treatments, 1 posttest).This test involves placing a device on the hand that shows the changing angle of the finger joint on a computer screen as the joint is moved. The computer screen also shows a target line, such as a sine wave. At the start of the test, the computer screen cursor moves horizontally across the target and the subject moves the finger joint into extension or flexion to adjust the vertical position of the cursor to that it traces the target line as accurately as possible. The performance is quantified by calculating the root-mean-square error between the target line and the response line. This is converted into an Accuracy Index, which has a maximum value of 100% (perfect score). Negative values can occur and reach a value of -100%, signifying very poor performance. Typical scores for healthy range from 50-80%. Typical values in stroke range from -100 to +40%. Changes that are positive signify increased tracking accuracy at posttest compared to pretest, which would be an improvement.
Outcome measures
| Measure |
Active rTMS With Conventional Therapy
n=2 Participants
20 minutes of active rTMS followed by conventional stroke therapy
active rTMS: 10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).
conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training
|
Sham rTMS With Conventional Therapy
n=2 Participants
20 minutes of sham rTMS stimulation followed by conventional stroke therapy
sham rTMS: 20 minutes of sham rTMS stimulation
conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training
|
|---|---|---|
|
Change in Finger Tracking Test
|
24.5 units on a scale
Standard Deviation 25.2
|
-13.8 units on a scale
Standard Deviation 41.8
|
SECONDARY outcome
Timeframe: Measured at pretest (day before treatments begin) and posttest (day following last treatment). Thus, 7 days of participation (1 pretest, 5 treatments, 1 posttest).Measures strength in finger pinch, elbow flexion and arm abduction. 0 No pinch movement. 11 Slight movement of finger or thumb. 19 Able to grip the cube, but not hold it against gravity. 22 Able to grip and hold the cube against gravity, but not against a weak pull by examiner. The weighted score based on the ordinal 6 point scale 26 Able to grip and hold the cube against a weak pull, but weaker than the other side. 33 Normal pinch grip. For shoulder and elbow scoring is: 0 No movement. 9 Palpable contraction in muscle, but no movement. 14 Visible movement, but not full range and not against gravity. 19 Full range of movement against gravity but not against resistance. 25 Full movement against resistance, but weaker than the other side. 33 Normal power. Maximum total score is 99, minimum is 0. Changes that are positive signify improved strength at postte
Outcome measures
| Measure |
Active rTMS With Conventional Therapy
n=2 Participants
20 minutes of active rTMS followed by conventional stroke therapy
active rTMS: 10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).
conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training
|
Sham rTMS With Conventional Therapy
n=2 Participants
20 minutes of sham rTMS stimulation followed by conventional stroke therapy
sham rTMS: 20 minutes of sham rTMS stimulation
conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training
|
|---|---|---|
|
Change in Motricity Index
|
4 units on a scale
Standard Deviation 5.7
|
11 units on a scale
Standard Deviation 0
|
Adverse Events
Active rTMS With Conventional Therapy
Sham rTMS With Conventional Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place