Trial Outcomes & Findings for Neurobiological Principles Applied to the Rehabilitation of Stroke Patients (NCT NCT00715520)
NCT ID: NCT00715520
Last Updated: 2017-10-16
Results Overview
Motor evoked potential (MEP) amplitudes were measured prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2), and 60 minutes after the treatment (post-training 3).The MEP is elicited by transcranial magnetic stimulation (TMS) at increased intensity. Its amplitude is measured from peak to peak and expressed in millivolts (mV). Measured MEP amplitudes were plotted against the intensity to create a stimulus response curve (SRC). SRCs were modeled by a 3- parameter sigmoid function and MEPmax was extracted. Long-lasting increases in MEP amplitude indicate increases in motor cortex excitability and are associated with motor learning.
COMPLETED
NA
33 participants
Baseline, Post-Training 1 (Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)
2017-10-16
Participant Flow
Participants were recruited between April 2007 and August 2013.
Participant milestones
| Measure |
Aim 1
Healthy adult female and male subjects received study drugs and TMS to measure M1 excitability.
|
Aim 2
Healthy adult female and male subjects received TMS prior to measuring wrist extension movements.
|
Aim 3
Female and male subjects who have experienced a cerebral ischemic infarction will receive study drugs and TMS to measure M1 excitability.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
10
|
3
|
|
Overall Study
COMPLETED
|
10
|
9
|
1
|
|
Overall Study
NOT COMPLETED
|
10
|
1
|
2
|
Reasons for withdrawal
| Measure |
Aim 1
Healthy adult female and male subjects received study drugs and TMS to measure M1 excitability.
|
Aim 2
Healthy adult female and male subjects received TMS prior to measuring wrist extension movements.
|
Aim 3
Female and male subjects who have experienced a cerebral ischemic infarction will receive study drugs and TMS to measure M1 excitability.
|
|---|---|---|---|
|
Overall Study
Screen failure
|
8
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Aim 1
n=10 Participants
Healthy adult female and male subjects received study drugs and TMS to measure M1 excitability.
|
Aim 2
n=9 Participants
Healthy adult female and male subjects received TMS prior to measuring wrist extension movements.
|
Aim 3
n=1 Participants
Female and male subjects who have experienced a cerebral ischemic infarction will receive study drugs and TMS to measure M1 excitability.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=10 Participants
|
7 Participants
n=9 Participants
|
1 Participants
n=1 Participants
|
15 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=10 Participants
|
2 Participants
n=9 Participants
|
0 Participants
n=1 Participants
|
5 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=10 Participants
|
6 Participants
n=9 Participants
|
1 Participants
n=1 Participants
|
12 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=10 Participants
|
3 Participants
n=9 Participants
|
0 Participants
n=1 Participants
|
8 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 Participants
n=10 Participants
|
9 Participants
n=9 Participants
|
1 Participants
n=1 Participants
|
20 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Baseline, Post-Training 1 (Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)Population: Analysis was completed in Aim 1 participants per protocol for the placebo condition. One subject was not included in the analysis due to corrupt data.
Motor evoked potential (MEP) amplitudes were measured prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2), and 60 minutes after the treatment (post-training 3).The MEP is elicited by transcranial magnetic stimulation (TMS) at increased intensity. Its amplitude is measured from peak to peak and expressed in millivolts (mV). Measured MEP amplitudes were plotted against the intensity to create a stimulus response curve (SRC). SRCs were modeled by a 3- parameter sigmoid function and MEPmax was extracted. Long-lasting increases in MEP amplitude indicate increases in motor cortex excitability and are associated with motor learning.
Outcome measures
| Measure |
Aim 1
n=9 Participants
Healthy adult female and male subjects received study drugs and TMS to measure M1 excitability.
|
|---|---|
|
Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC)
Baseline Placebo - MEPmax
|
1.01 mV
Standard Error .13
|
|
Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC)
Post-Training 1 Placebo - MEPmax
|
1.63 mV
Standard Error .33
|
|
Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC)
Post-Training 2 Placebo - MEPmax
|
1.29 mV
Standard Error .05
|
|
Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC)
Baseline - Amphetamine Sulfate - MEPmax
|
.73 mV
Standard Error .10
|
|
Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC)
Post-Training 1 Ampletamine Sulfate - MEPmax
|
1.22 mV
Standard Error .26
|
|
Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC)
Post-Training 2 Amphetamine Sulfate - MEPmax
|
1.08 mV
Standard Error .04
|
|
Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC)
Baseline Methylphenidate - MEPmax
|
1.04 mV
Standard Error .13
|
|
Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC)
Post-Training 1 Methylphenidate - MEPmax
|
1.10 mV
Standard Error .12
|
|
Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC)
Post-Training 2 Methylphenidate - MEPmax
|
1.22 mV
Standard Error .06
|
|
Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC)
Baseline Carbidopa-Levodopa - MEPmax
|
1.81 mV
Standard Error .62
|
|
Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC)
Post-Training 1 Carbidopa-Levodopa - MEPmax
|
1.41 mV
Standard Error .26
|
|
Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC)
Post-Training 2 Carbidopa-Levodopa - MEPmax
|
1.53 mV
Standard Error .13
|
PRIMARY outcome
Timeframe: Baseline, Post-Training 1 (Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)Population: Analysis was completed in Aim 1 participants per protocol. One subject was not included in the analysis due to corrupt data.
Mean peak acceleration was measured across study drug conditions prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface.
Outcome measures
| Measure |
Aim 1
n=9 Participants
Healthy adult female and male subjects received study drugs and TMS to measure M1 excitability.
|
|---|---|
|
Aim 1: Mean Peak Acceleration of Wrist Extension Movements
Baseline - Placebo
|
1.32 g
Standard Deviation .35
|
|
Aim 1: Mean Peak Acceleration of Wrist Extension Movements
Post-Training 1 - Placebo
|
1.33 g
Standard Deviation .21
|
|
Aim 1: Mean Peak Acceleration of Wrist Extension Movements
Post-Training 2 - Placebo
|
1.24 g
Standard Deviation .30
|
|
Aim 1: Mean Peak Acceleration of Wrist Extension Movements
Baseline - Amphetamine Sulfate
|
1.24 g
Standard Deviation .33
|
|
Aim 1: Mean Peak Acceleration of Wrist Extension Movements
Post-Training 1 - Amphetamine Sulfate
|
1.28 g
Standard Deviation .31
|
|
Aim 1: Mean Peak Acceleration of Wrist Extension Movements
Post-Training 2 - Amphetamine Sulfate
|
1.29 g
Standard Deviation .39
|
|
Aim 1: Mean Peak Acceleration of Wrist Extension Movements
Baseline - Methylphenidate
|
1.35 g
Standard Deviation .30
|
|
Aim 1: Mean Peak Acceleration of Wrist Extension Movements
Post-Training 1 - Methylphenidate
|
1.27 g
Standard Deviation .16
|
|
Aim 1: Mean Peak Acceleration of Wrist Extension Movements
Post-Training 2 - Methylphenidate
|
1.22 g
Standard Deviation .25
|
|
Aim 1: Mean Peak Acceleration of Wrist Extension Movements
Baseline - Carbidopa-Levodopa
|
1.22 g
Standard Deviation .39
|
|
Aim 1: Mean Peak Acceleration of Wrist Extension Movements
Post-Training 1 - Carbidopa-Levodopa
|
1.23 g
Standard Deviation .27
|
|
Aim 1: Mean Peak Acceleration of Wrist Extension Movements
Post-Training 2 - Carbidopa-Levodopa
|
1.37 g
Standard Deviation .38
|
SECONDARY outcome
Timeframe: Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)Population: Analysis was completed in Aim 2 participants per protocol.
Mean sum of normalized MEP for repeated TMS (rTMS) conditions with respect to the pulse (-100, +300, placebo, zero) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Its amplitude is measured from peak to peak and expressed in mV. Long- lasting increases in MEP amplitude indicate increases in motor cortex excitability and are associated with motor learning.
Outcome measures
| Measure |
Aim 1
n=9 Participants
Healthy adult female and male subjects received study drugs and TMS to measure M1 excitability.
|
|---|---|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) With Respect to Pulse
Baseline - Pulse (+300)
|
.38 millivolts
Standard Deviation .38
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) With Respect to Pulse
Post-Training 1 - Pulse (+300)
|
.54 millivolts
Standard Deviation .51
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) With Respect to Pulse
Baseline - Pulse (zero)
|
.39 millivolts
Standard Deviation .36
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) With Respect to Pulse
Post-Training 1 - Pulse (zero)
|
.66 millivolts
Standard Deviation .74
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) With Respect to Pulse
Post-Training 2 - Pulse (zero)
|
.63 millivolts
Standard Deviation .63
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) With Respect to Pulse
Post-Training 3 - Pulse (zero)
|
.69 millivolts
Standard Deviation .76
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) With Respect to Pulse
Baseline - Pulse (placebo)
|
.40 millivolts
Standard Deviation .38
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) With Respect to Pulse
Post-Training 1 - Pulse (placebo)
|
.54 millivolts
Standard Deviation .57
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) With Respect to Pulse
Post-Training 2 - Pulse (placebo)
|
.51 millivolts
Standard Deviation .59
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) With Respect to Pulse
Post-Training 3 - Pulse (placebo)
|
.52 millivolts
Standard Deviation .59
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) With Respect to Pulse
Baseline - Pulse (-100)
|
.39 millivolts
Standard Deviation .37
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) With Respect to Pulse
Post-Training 1 - Pulse (-100)
|
.56 millivolts
Standard Deviation .54
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) With Respect to Pulse
Post-Training 2 - Pulse (-100)
|
.60 millivolts
Standard Deviation .67
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) With Respect to Pulse
Post-Training 3 - Pulse (-100)
|
.61 millivolts
Standard Deviation .63
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) With Respect to Pulse
Post-Training 2 - Pulse (+300)
|
.48 millivolts
Standard Deviation .45
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) With Respect to Pulse
Post-Training 3 - Pulse (+300)
|
.51 millivolts
Standard Deviation .50
|
SECONDARY outcome
Timeframe: Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)Population: Analysis was completed in Aim 2 participants per protocol.
Mean peak acceleration of wrist movements for repeated TMS (rTMS) conditions with respect of the TMS pulse (-100, +300, placebo, zero) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface.
Outcome measures
| Measure |
Aim 1
n=9 Participants
Healthy adult female and male subjects received study drugs and TMS to measure M1 excitability.
|
|---|---|
|
Aim 2: Mean Peak Acceleration of Wrist Extension Movements With Respect to Pulse
Baseline - Pulse (zero)
|
1.33 g
Standard Deviation .31
|
|
Aim 2: Mean Peak Acceleration of Wrist Extension Movements With Respect to Pulse
Post-Training 1 - Pulse (zero)
|
1.43 g
Standard Deviation .30
|
|
Aim 2: Mean Peak Acceleration of Wrist Extension Movements With Respect to Pulse
Post-Training 2 - Pulse (zero)
|
1.51 g
Standard Deviation .34
|
|
Aim 2: Mean Peak Acceleration of Wrist Extension Movements With Respect to Pulse
Post-Training 3 - Pulse (zero)
|
1.53 g
Standard Deviation .37
|
|
Aim 2: Mean Peak Acceleration of Wrist Extension Movements With Respect to Pulse
Baseline - Pulse (placebo)
|
1.44 g
Standard Deviation .25
|
|
Aim 2: Mean Peak Acceleration of Wrist Extension Movements With Respect to Pulse
Post-Training 1 - Pulse (placebo)
|
1.36 g
Standard Deviation .24
|
|
Aim 2: Mean Peak Acceleration of Wrist Extension Movements With Respect to Pulse
Post-Training 2 - Pulse (placebo)
|
1.35 g
Standard Deviation .24
|
|
Aim 2: Mean Peak Acceleration of Wrist Extension Movements With Respect to Pulse
Post-Training 3 - Pulse (placebo)
|
1.33 g
Standard Deviation .30
|
|
Aim 2: Mean Peak Acceleration of Wrist Extension Movements With Respect to Pulse
Baseline - Pulse (-100)
|
1.51 g
Standard Deviation .34
|
|
Aim 2: Mean Peak Acceleration of Wrist Extension Movements With Respect to Pulse
Post-Training 1 - Pulse (-100)
|
1.5 g
Standard Deviation .30
|
|
Aim 2: Mean Peak Acceleration of Wrist Extension Movements With Respect to Pulse
Post-Training 2 - Pulse (-100)
|
1.46 g
Standard Deviation .34
|
|
Aim 2: Mean Peak Acceleration of Wrist Extension Movements With Respect to Pulse
Post-Training 3 - Pulse (-100)
|
1.47 g
Standard Deviation .27
|
|
Aim 2: Mean Peak Acceleration of Wrist Extension Movements With Respect to Pulse
Baseline - Pulse (+300)
|
1.40 g
Standard Deviation .34
|
|
Aim 2: Mean Peak Acceleration of Wrist Extension Movements With Respect to Pulse
Post-Training 1 - Pulse (+300)
|
1.32 g
Standard Deviation .35
|
|
Aim 2: Mean Peak Acceleration of Wrist Extension Movements With Respect to Pulse
Post-Training 2 - Pulse (+300)
|
1.38 g
Standard Deviation .40
|
|
Aim 2: Mean Peak Acceleration of Wrist Extension Movements With Respect to Pulse
Post-Training 3 - Pulse (+300)
|
1.40 g
Standard Deviation .43
|
SECONDARY outcome
Timeframe: Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)Population: Analysis was completed in Aim 2 participants per protocol.
Mean sum of normalized MEP for the different frequencies of rTMS treatment (placebo at 0.1 Hz, 0.1 Hz, 0.25 Hz, 0.5 Hz) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning.
Outcome measures
| Measure |
Aim 1
n=9 Participants
Healthy adult female and male subjects received study drugs and TMS to measure M1 excitability.
|
|---|---|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) for rTMS Treatment With Respect to Frequency
Baseline - Placebo
|
.67 millivolts
Standard Deviation .79
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) for rTMS Treatment With Respect to Frequency
Post-Training 1 - Placebo
|
.93 millivolts
Standard Deviation 1.00
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) for rTMS Treatment With Respect to Frequency
Post-Training 2 - Placebo
|
.94 millivolts
Standard Deviation 1.09
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) for rTMS Treatment With Respect to Frequency
Post-Training 3 - Placebo
|
1.02 millivolts
Standard Deviation 1.19
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) for rTMS Treatment With Respect to Frequency
Baseline - .1 Hz
|
.71 millivolts
Standard Deviation .83
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) for rTMS Treatment With Respect to Frequency
Post-Training 1 - .1 Hz
|
1.06 millivolts
Standard Deviation 1.15
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) for rTMS Treatment With Respect to Frequency
Post-Training 2 - .1 Hz
|
1.06 millivolts
Standard Deviation 1.23
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) for rTMS Treatment With Respect to Frequency
Post-Training 3 - .1 Hz
|
1.14 millivolts
Standard Deviation 1.24
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) for rTMS Treatment With Respect to Frequency
Baseline - .25 Hz
|
.67 millivolts
Standard Deviation .84
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) for rTMS Treatment With Respect to Frequency
Post-Training 1 - .25 Hz
|
.90 millivolts
Standard Deviation 1.03
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) for rTMS Treatment With Respect to Frequency
Post-Training 2 - .25 Hz
|
.90 millivolts
Standard Deviation 1.08
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) for rTMS Treatment With Respect to Frequency
Post-Training 3 - .25 Hz
|
.98 millivolts
Standard Deviation 1.15
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) for rTMS Treatment With Respect to Frequency
Baseline - .5 Hz
|
.64 millivolts
Standard Deviation .74
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) for rTMS Treatment With Respect to Frequency
Post-Training 1 - .5 Hz
|
.92 millivolts
Standard Deviation 1.11
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) for rTMS Treatment With Respect to Frequency
Post-Training 2 - .5 Hz
|
.90 millivolts
Standard Deviation .99
|
|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) for rTMS Treatment With Respect to Frequency
Post-Training 3 - .5 Hz
|
.84 millivolts
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)Population: Analysis was completed in Aim 2 participants per protocol.
Mean peak acceleration for the different frequencies of rTMS treatment (placebo, 0.1 Hz, 0.25 Hz, 0.5 Hz) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface.
Outcome measures
| Measure |
Aim 1
n=9 Participants
Healthy adult female and male subjects received study drugs and TMS to measure M1 excitability.
|
|---|---|
|
Aim 2: Mean Peak Acceleration for rTMS Treatment With Respect to Frequency
Baseline - Placebo
|
1.44 g
Standard Deviation .25
|
|
Aim 2: Mean Peak Acceleration for rTMS Treatment With Respect to Frequency
Post-Training 1 - Placebo
|
1.36 g
Standard Deviation .24
|
|
Aim 2: Mean Peak Acceleration for rTMS Treatment With Respect to Frequency
Post-Training 2 - Placebo
|
1.35 g
Standard Deviation .24
|
|
Aim 2: Mean Peak Acceleration for rTMS Treatment With Respect to Frequency
Post-Training 3 - Placebo
|
1.33 g
Standard Deviation .30
|
|
Aim 2: Mean Peak Acceleration for rTMS Treatment With Respect to Frequency
Baseline - .1 Hz
|
1.33 g
Standard Deviation .31
|
|
Aim 2: Mean Peak Acceleration for rTMS Treatment With Respect to Frequency
Post-Training 1 - .1 Hz
|
1.43 g
Standard Deviation .30
|
|
Aim 2: Mean Peak Acceleration for rTMS Treatment With Respect to Frequency
Post-Training 2 - .1 Hz
|
1.50 g
Standard Deviation .34
|
|
Aim 2: Mean Peak Acceleration for rTMS Treatment With Respect to Frequency
Post-Training 3 - .1 Hz
|
1.53 g
Standard Deviation .37
|
|
Aim 2: Mean Peak Acceleration for rTMS Treatment With Respect to Frequency
Baseline - .25 Hz
|
1.38 g
Standard Deviation .26
|
|
Aim 2: Mean Peak Acceleration for rTMS Treatment With Respect to Frequency
Post-Training 1 - .25 Hz
|
1.35 g
Standard Deviation .44
|
|
Aim 2: Mean Peak Acceleration for rTMS Treatment With Respect to Frequency
Post-Training 2 - .25 Hz
|
1.40 g
Standard Deviation .37
|
|
Aim 2: Mean Peak Acceleration for rTMS Treatment With Respect to Frequency
Post-Training 3 - .25 Hz
|
1.34 g
Standard Deviation .47
|
|
Aim 2: Mean Peak Acceleration for rTMS Treatment With Respect to Frequency
Baseline - .5 Hz
|
1.32 g
Standard Deviation .23
|
|
Aim 2: Mean Peak Acceleration for rTMS Treatment With Respect to Frequency
Post-Training 1 - .5 Hz
|
1.29 g
Standard Deviation .30
|
|
Aim 2: Mean Peak Acceleration for rTMS Treatment With Respect to Frequency
Post-Training 2 - .5 Hz
|
1.25 g
Standard Deviation .29
|
|
Aim 2: Mean Peak Acceleration for rTMS Treatment With Respect to Frequency
Post-Training 3 - .5 Hz
|
1.29 g
Standard Deviation .31
|
SECONDARY outcome
Timeframe: Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)Population: No sufficient data collected.
Motor evoked potential (MEP) amplitudes were measured prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2), and 60 minutes after the treatment (post-training 3).The MEP is elicited by transcranial magnetic stimulation (TMS) at increased intensity. Its amplitude is measured from peak to peak and expressed in millivolts (mV). Measured MEP amplitudes were plotted against the intensity to create a stimulus response curve (SRC). SRCs were modeled by a 3- parameter sigmoid function and MEPmax was extracted. Long-lasting increases in MEP amplitude indicate increases in motor cortex excitability and are associated with motor learning.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)Population: No sufficient data collected.
Mean peak acceleration was measured across study drug conditions prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface.
Outcome measures
Outcome data not reported
Adverse Events
Aim 1
Aim 2
Aim 3
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aim 1
n=10 participants at risk
Healthy adult female and male subjects received study drugs and TMS to measure M1 excitability.
|
Aim 2
n=9 participants at risk
Healthy adult female and male subjects received TMS prior to measuring wrist extension movements.
|
Aim 3
n=1 participants at risk
Female and male subjects who have experienced a cerebral ischemic infarction will receive study drugs and TMS to measure M1 excitability.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertio
|
10.0%
1/10 • Number of events 1 • Adverse events were collected throughout the duration of the study (6 years, 6 months).
|
0.00%
0/9 • Adverse events were collected throughout the duration of the study (6 years, 6 months).
|
0.00%
0/1 • Adverse events were collected throughout the duration of the study (6 years, 6 months).
|
|
Vascular disorders
Increased Blood Pressure
|
10.0%
1/10 • Number of events 1 • Adverse events were collected throughout the duration of the study (6 years, 6 months).
|
0.00%
0/9 • Adverse events were collected throughout the duration of the study (6 years, 6 months).
|
0.00%
0/1 • Adverse events were collected throughout the duration of the study (6 years, 6 months).
|
|
Nervous system disorders
Dizziness
|
30.0%
3/10 • Number of events 3 • Adverse events were collected throughout the duration of the study (6 years, 6 months).
|
0.00%
0/9 • Adverse events were collected throughout the duration of the study (6 years, 6 months).
|
0.00%
0/1 • Adverse events were collected throughout the duration of the study (6 years, 6 months).
|
|
Gastrointestinal disorders
Dry Mouth
|
10.0%
1/10 • Number of events 1 • Adverse events were collected throughout the duration of the study (6 years, 6 months).
|
0.00%
0/9 • Adverse events were collected throughout the duration of the study (6 years, 6 months).
|
0.00%
0/1 • Adverse events were collected throughout the duration of the study (6 years, 6 months).
|
|
Nervous system disorders
Parathesis
|
10.0%
1/10 • Number of events 1 • Adverse events were collected throughout the duration of the study (6 years, 6 months).
|
0.00%
0/9 • Adverse events were collected throughout the duration of the study (6 years, 6 months).
|
0.00%
0/1 • Adverse events were collected throughout the duration of the study (6 years, 6 months).
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • Number of events 2 • Adverse events were collected throughout the duration of the study (6 years, 6 months).
|
0.00%
0/9 • Adverse events were collected throughout the duration of the study (6 years, 6 months).
|
0.00%
0/1 • Adverse events were collected throughout the duration of the study (6 years, 6 months).
|
|
Nervous system disorders
Somnolence
|
50.0%
5/10 • Number of events 5 • Adverse events were collected throughout the duration of the study (6 years, 6 months).
|
0.00%
0/9 • Adverse events were collected throughout the duration of the study (6 years, 6 months).
|
0.00%
0/1 • Adverse events were collected throughout the duration of the study (6 years, 6 months).
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/10 • Adverse events were collected throughout the duration of the study (6 years, 6 months).
|
0.00%
0/9 • Adverse events were collected throughout the duration of the study (6 years, 6 months).
|
100.0%
1/1 • Number of events 1 • Adverse events were collected throughout the duration of the study (6 years, 6 months).
|
|
General disorders
Facial Edema
|
0.00%
0/10 • Adverse events were collected throughout the duration of the study (6 years, 6 months).
|
0.00%
0/9 • Adverse events were collected throughout the duration of the study (6 years, 6 months).
|
100.0%
1/1 • Number of events 1 • Adverse events were collected throughout the duration of the study (6 years, 6 months).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place