Trial Outcomes & Findings for Immediate Effects of rTMS on Excitability of the Quadriceps With Knee Osteoarthritis (NCT NCT02881775)
NCT ID: NCT02881775
Last Updated: 2019-06-11
Results Overview
Quadriceps Central Activation Ratio (CAR) is a percentage of the amount of torque produced during the superimposed burst technique using maximal voluntary isometric contraction (MVIC) and superimposed burst torque. It is reported on a scale of 0 (worst) to 100% (best) activation.
COMPLETED
NA
20 participants
Within 1 hour post intervention
2019-06-11
Participant Flow
Participant milestones
| Measure |
rTMS and Exercise, Then Sham rTMS and Exercise
At lab visit, subjects receive repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive sham rTMS and exercise using the same parameters.
rTMS and exercise: rTMS at 10 Hz (5 sec on, 55 sec off) and light quadriceps isometric exercise (5% MVIC)
Sham rTMS and exercise: rTMS unit is on and running but mu metal is placed between the coil and the skull
|
Sham rTMS and Exercise, Then rTMS and Exercise
At lab visit, subjects receive sham repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive the "true" rTMS and exercise using the same parameters.
rTMS and exercise: rTMS at 10 Hz (5 sec on, 55 sec off) and light quadriceps isometric exercise (5% MVIC)
Sham rTMS and exercise: rTMS unit is on and running but mu metal is placed between the coil and the skull
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|---|---|---|
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Baseline
STARTED
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11
|
9
|
|
Baseline
COMPLETED
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11
|
9
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
First Intervention (1-hr Session)
STARTED
|
9
|
7
|
|
First Intervention (1-hr Session)
COMPLETED
|
9
|
7
|
|
First Intervention (1-hr Session)
NOT COMPLETED
|
0
|
0
|
|
Washout (1 Week)
STARTED
|
9
|
7
|
|
Washout (1 Week)
COMPLETED
|
9
|
7
|
|
Washout (1 Week)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (1-Hour Session)
STARTED
|
9
|
7
|
|
Second Intervention (1-Hour Session)
COMPLETED
|
9
|
7
|
|
Second Intervention (1-Hour Session)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immediate Effects of rTMS on Excitability of the Quadriceps With Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
All Study Participants
n=20 Participants
Participants who were randomized to receive either rTMS and exercise or sham rTMS and exercise.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 1 hour post interventionPopulation: 4 subjects withdrew from the study after the baseline measures. This left 16 subjects for the intervention arm of the study. Four subjects declined to perform the test after the experience with the electrical stimulus in the baseline session.
Quadriceps Central Activation Ratio (CAR) is a percentage of the amount of torque produced during the superimposed burst technique using maximal voluntary isometric contraction (MVIC) and superimposed burst torque. It is reported on a scale of 0 (worst) to 100% (best) activation.
Outcome measures
| Measure |
rTMS and Exercise
n=12 Participants
At lab visit, subjects receive repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive sham rTMS and exercise using the same parameters.
|
Sham rTMS and Exercise
n=12 Participants
At lab visit, subjects receive sham repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive the "true" rTMS and exercise using the same parameters.
|
|---|---|---|
|
Quadriceps Central Activation Ratio (CAR)
CAR Baseline (BL)
|
86.3554 % activation
Standard Error 3.2921
|
86.1983 % activation
Standard Error 3.2921
|
|
Quadriceps Central Activation Ratio (CAR)
CAR BL Change
|
-1.2496 % activation
Standard Error 2.1397
|
-1.2670 % activation
Standard Error 2.1397
|
PRIMARY outcome
Timeframe: Within 1 hour post interventionPopulation: 4 subjects withdrew from the study after the baseline measures. This left 16 subjects for the intervention arm of the study.
HUMAC NORM electromechanical dynamometer is used to measure isometric torque generation in quadriceps muscle stabilized with 70 degrees of knee flexion. Units of measure are in Newton meters (Nm).
Outcome measures
| Measure |
rTMS and Exercise
n=16 Participants
At lab visit, subjects receive repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive sham rTMS and exercise using the same parameters.
|
Sham rTMS and Exercise
n=16 Participants
At lab visit, subjects receive sham repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive the "true" rTMS and exercise using the same parameters.
|
|---|---|---|
|
Quadriceps Maximal Voluntary Isometric Contraction (MVIC)
MVIC Baseline
|
129.46 Nm
Standard Error 11.8464
|
129.09 Nm
Standard Error 11.8464
|
|
Quadriceps Maximal Voluntary Isometric Contraction (MVIC)
MVIC BL Change
|
-6.3473 Nm
Standard Error 4.4266
|
-6.1643 Nm
Standard Error 4.4266
|
SECONDARY outcome
Timeframe: Within 1 hour post interventionPopulation: 4 subjects withdrew from the study after the baseline measures. This left 16 subjects for the intervention arm of the study. For two subjects, the research assistant missed obtaining the post-intervention pain rating.
Pain intensity is rated on a visual analog scale of 0-10 where 0 is no pain and 10 is maximum pain
Outcome measures
| Measure |
rTMS and Exercise
n=16 Participants
At lab visit, subjects receive repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive sham rTMS and exercise using the same parameters.
|
Sham rTMS and Exercise
n=14 Participants
At lab visit, subjects receive sham repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive the "true" rTMS and exercise using the same parameters.
|
|---|---|---|
|
Numeric Pain Rating Scale (NPRS) Score
NPRS BL Change
|
-.625 score on scale
Standard Error .4187
|
-.1570 score on scale
Standard Error .4378
|
|
Numeric Pain Rating Scale (NPRS) Score
NPRS Baseline
|
3.25 score on scale
Standard Error .5749
|
3.000 score on scale
Standard Error .5749
|
SECONDARY outcome
Timeframe: Within 1 hour post interventionPopulation: 4 subjects withdrew from the study after the baseline measures. This left 16 subjects for the intervention arm of the study.
Using the AlgoMed algometer, pressure at a rate of 35 kPA/second is applied to the medial knee to the level that subject indicates is painful. Units of measure are kilopascal (kPa)
Outcome measures
| Measure |
rTMS and Exercise
n=16 Participants
At lab visit, subjects receive repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive sham rTMS and exercise using the same parameters.
|
Sham rTMS and Exercise
n=16 Participants
At lab visit, subjects receive sham repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive the "true" rTMS and exercise using the same parameters.
|
|---|---|---|
|
Pressure Pain Threshold (PPT) - Medial Knee
PPT Baseline
|
402.41 kPa
Standard Error 60.1780
|
419.21 kPa
Standard Error 60.1780
|
|
Pressure Pain Threshold (PPT) - Medial Knee
PPT BL Change
|
21.8583 kPa
Standard Error 28.0167
|
4.3548 kPa
Standard Error 28.0167
|
SECONDARY outcome
Timeframe: Within 1 hour post interventionPopulation: 4 subjects withdrew from the study after the baseline measures. This left 16 subjects for the intervention arm of the study.
Time in seconds to rise from a chair, walk 3 m, return and sit down
Outcome measures
| Measure |
rTMS and Exercise
n=16 Participants
At lab visit, subjects receive repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive sham rTMS and exercise using the same parameters.
|
Sham rTMS and Exercise
n=16 Participants
At lab visit, subjects receive sham repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive the "true" rTMS and exercise using the same parameters.
|
|---|---|---|
|
Timed Up & Go (TUG)
TUG Baseline
|
8.3919 seconds
Standard Error .4079
|
8.3056 seconds
Standard Error .4079
|
|
Timed Up & Go (TUG)
TUG BL Change
|
-.08021 seconds
Standard Error .803
|
-.00542 seconds
Standard Error .1803
|
SECONDARY outcome
Timeframe: Within 1 hour post interventionPopulation: 4 subjects withdrew from the study after the baseline measures. This left 16 subjects for the intervention arm of the study. A technical issue in how the TMS unit worked was discovered after collecting the first 4 subjects in the intervention part of the study. This impacted their AMT-MEP, ICF, and SICI data which were excluded from the analyses.
The quadriceps active muscle responses (motor evoked potentials) that result from the single-pulse transcranial magnetic stimulation (TMS) pulses over the motor cortex. These AMT-MEP are measured peak-to-peak in microvolts (uV ). 10 AMT-MEP values were collected and averaged.
Outcome measures
| Measure |
rTMS and Exercise
n=12 Participants
At lab visit, subjects receive repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive sham rTMS and exercise using the same parameters.
|
Sham rTMS and Exercise
n=12 Participants
At lab visit, subjects receive sham repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive the "true" rTMS and exercise using the same parameters.
|
|---|---|---|
|
Active Motor Threshold Motor Evoked Potential (AMT-MEP)
AMT-MEP Baseline
|
.1387 uV
Standard Error .009634
|
.1434 uV
Standard Error .009634
|
|
Active Motor Threshold Motor Evoked Potential (AMT-MEP)
AMT-MEP BL Change
|
-.00007 uV
Standard Error .01107
|
-.01441 uV
Standard Error .01107
|
SECONDARY outcome
Timeframe: Within 1 hour post interventionPopulation: 4 subjects withdrew from the study after the baseline measures. This left 16 subjects for the intervention arm of the study. A technical issue in how the TMS unit worked was discovered after collecting the first 4 subjects in the intervention part of the study. This impacted their AMT-MEP, ICF, and SICI data which were excluded from the analyses.
Transcranial magnetic stimulation (TMS), using the conditioning-test paired-pulse paradigm with a 3 ms interval, will be used. SICI is the ratio of the conditioning stimulus relative to the test stimulus. A ratio \< 1.0 indicates inhibition.
Outcome measures
| Measure |
rTMS and Exercise
n=12 Participants
At lab visit, subjects receive repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive sham rTMS and exercise using the same parameters.
|
Sham rTMS and Exercise
n=12 Participants
At lab visit, subjects receive sham repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive the "true" rTMS and exercise using the same parameters.
|
|---|---|---|
|
Short Interval Cortical Inhibition (SICI)
SICI Baseline
|
.5140 ratio
Standard Error .054
|
.5996 ratio
Standard Error .1054
|
|
Short Interval Cortical Inhibition (SICI)
SICI BL Change
|
-.02588 ratio
Standard Error .07227
|
-.1151 ratio
Standard Error .07227
|
SECONDARY outcome
Timeframe: Within 1 hour post interventionPopulation: 4 subjects withdrew from the study after the baseline measures. This left 16 subjects for the intervention arm of the study. A technical issue in how the TMS unit worked was discovered after collecting the first 4 subjects in the intervention part of the study. This impacted their AMT-MEP, ICF, and SICI data which were excluded from the analyses.
Transcranial magnetic stimulation (TMS), using the conditioning-test paired-pulse paradigm with a 15 ms interval, will be used. ICF is the ratio of the conditioning stimulus relative to the test stimulus. A ratio \> 1.0 indicates facilitation.
Outcome measures
| Measure |
rTMS and Exercise
n=12 Participants
At lab visit, subjects receive repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive sham rTMS and exercise using the same parameters.
|
Sham rTMS and Exercise
n=12 Participants
At lab visit, subjects receive sham repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive the "true" rTMS and exercise using the same parameters.
|
|---|---|---|
|
Intra Cortical Facilitation (ICF)
ICF BL Change
|
-.0354 ratio
Standard Error .1896
|
.03042 ratio
Standard Error .1896
|
|
Intra Cortical Facilitation (ICF)
ICF Baseline
|
1.193 ratio
Standard Error .903
|
.904 ratio
Standard Error .903
|
Adverse Events
rTMS and Exercise
Sham rTMS and Exercise
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Deborah Givens, PhD
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place