Trial Outcomes & Findings for Transcranial Magnetic Stimulation Effects on Pain Perception (NCT NCT01861574)
NCT ID: NCT01861574
Last Updated: 2018-09-27
Results Overview
PCA pump usage values were reported by concentration in mg/mL. Post operative PCA pump usage was tracked 0-48 hours after surgery. The PCA pump usage was downloaded from the PCA pump after discharge from the hospital and values were reported in mg/mL (concentration in mg/mL). The PCA pump data were averaged over Post-operative hours 0-48 (total PCA pump usage post-operatively) and the mean PCA pump usage was calculated and reported in mg/mL for all groups (4).
COMPLETED
NA
108 participants
Post-Op Hour 0 through 48
2018-09-27
Participant Flow
Participant milestones
| Measure |
Both Real TMS
Gastric-Bypass Patients receive Real TMS 45 minutes after gastric-bypass surgery Gastric-Bypass Patients receive Real TMS 4 hours after gastric-bypass surgery
|
Sham Then Real TMS
Gastric-Bypass Patients receive Sham TMS 45 minutes after gastric-bypass surgery Gastric-Bypass Patients receive Real TMS 4 hours after gastric-bypass surgery
|
Real Then Sham TMS
Gastric-Bypass Patients receive Real TMS 45 minutes after gastric-bypass surgery Gastric-Bypass Patients receive Sham TMS 4 hours after gastric-bypass surgery
|
Both Sham TMS
Gastric-Bypass Patients receive Sham TMS 45 minutes after gastric-bypass surgery Gastric-Bypass Patients receive Sham TMS 4 hours after gastric-bypass surgery
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
28
|
25
|
27
|
28
|
|
Overall Study
COMPLETED
|
28
|
25
|
27
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transcranial Magnetic Stimulation Effects on Pain Perception
Baseline characteristics by cohort
| Measure |
Both Real TMS
n=28 Participants
Gastric-Bypass Patients receive Real TMS 45 minutes after gastric-bypass surgery Gastric-Bypass Patients receive Real TMS 4 hours after gastric-bypass surgery
|
Sham Then Real TMS
n=25 Participants
Gastric-Bypass Patients receive Sham TMS 45 minutes after gastric-bypass surgery Gastric-Bypass Patients receive Real TMS 4 hours after gastric-bypass surgery
|
Real Then Sham TMS
n=27 Participants
Gastric-Bypass Patients receive Real TMS 45 minutes after gastric-bypass surgery Gastric-Bypass Patients receive Sham TMS 4 hours after gastric-bypass surgery
|
Both Sham TMS
n=28 Participants
Gastric-Bypass Patients receive Sham TMS 45 minutes after gastric-bypass surgery Gastric-Bypass Patients receive Sham TMS 4 hours after gastric-bypass surgery
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
79 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
25 participants
n=7 Participants
|
27 participants
n=5 Participants
|
28 participants
n=4 Participants
|
108 participants
n=21 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
108 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
48.21 years
STANDARD_DEVIATION 11.90 • n=5 Participants
|
45.44 years
STANDARD_DEVIATION 10.07 • n=7 Participants
|
44.33 years
STANDARD_DEVIATION 8.96 • n=5 Participants
|
49.89 years
STANDARD_DEVIATION 12.35 • n=4 Participants
|
47.04 years
STANDARD_DEVIATION 11.02 • n=21 Participants
|
PRIMARY outcome
Timeframe: Post-Op Hour 0 through 48PCA pump usage values were reported by concentration in mg/mL. Post operative PCA pump usage was tracked 0-48 hours after surgery. The PCA pump usage was downloaded from the PCA pump after discharge from the hospital and values were reported in mg/mL (concentration in mg/mL). The PCA pump data were averaged over Post-operative hours 0-48 (total PCA pump usage post-operatively) and the mean PCA pump usage was calculated and reported in mg/mL for all groups (4).
Outcome measures
| Measure |
Both Real TMS
n=28 Participants
Participants in the Both Real TMS group receive 20 minutes of Real TMS 45 minutes after gastric-bypass surgery and then another 20 minutes of Real TMS 4 hours after surgery.
|
Sham Then Real TMS
n=25 Participants
Participants in the Sham then Real TMS group, receive Sham TMS 45 minutes after gastric-bypass surgery and 20 minutes of Real TMS 4 hours after surgery.
|
Real Then Sham TMS
n=27 Participants
Participants in the Real then Sham TMS group receive 20 minutes of Real TMS 45 minutes after gastric-bypass surgery and then 20 minutes of Sham TMS 4 hours after surgery.
|
Both Sham TMS
n=28 Participants
Participants in the Both Sham TMS group, receive Sham TMS 45 minutes after gastric-bypass surgery and then another 20 minutes of Sham TMS 4 hours after surgery
|
|---|---|---|---|---|
|
Patient Controlled Analgesia (PCA) Hydromorphone Usage
|
11.77 mg/ml
Standard Deviation 7.67
|
13.42 mg/ml
Standard Deviation 6.92
|
12.66 mg/ml
Standard Deviation 7.65
|
9.83 mg/ml
Standard Deviation 5.59
|
PRIMARY outcome
Timeframe: Check Up 1, Check Up 2, Check Up 3, and Check Up 4Participants completed the McGill Pain Questionnaire-short form (MPQ) at Check Up 1, Check Up 2, Check Up 3, and Check Up 4. Check Up 1 \& 2 occurred on Post-Op Day 1. Check Up 1 occurred immediately after surgery. Check Up 2 occurred 4 hours after Check Up 1. Check Up 3 \& 4 occurred on Post-Op Day 2, 4 hours apart. The MPQ has two pain dimensions: 1.Sensory subscale with 11 words, and 2.Affective subscale with 4 words from the original MPQ. The range of scores for the affective dimension of pain is 0-12. The range of scores for the sensory dimension of pain is 0-33. The maximum total score for the sensory dimension is 33. Higher scores are indicative of worse pain on the sensory dimension of pain.
Outcome measures
| Measure |
Both Real TMS
n=28 Participants
Participants in the Both Real TMS group receive 20 minutes of Real TMS 45 minutes after gastric-bypass surgery and then another 20 minutes of Real TMS 4 hours after surgery.
|
Sham Then Real TMS
n=25 Participants
Participants in the Sham then Real TMS group, receive Sham TMS 45 minutes after gastric-bypass surgery and 20 minutes of Real TMS 4 hours after surgery.
|
Real Then Sham TMS
n=27 Participants
Participants in the Real then Sham TMS group receive 20 minutes of Real TMS 45 minutes after gastric-bypass surgery and then 20 minutes of Sham TMS 4 hours after surgery.
|
Both Sham TMS
n=25 Participants
Participants in the Both Sham TMS group, receive Sham TMS 45 minutes after gastric-bypass surgery and then another 20 minutes of Sham TMS 4 hours after surgery
|
|---|---|---|---|---|
|
Sensory Dimension of McGill Pain Questionnaire
Check up 1
|
6.33 units on a scale
Standard Error 1.35
|
5.36 units on a scale
Standard Error 1.06
|
4.8 units on a scale
Standard Error 0.84
|
5.71 units on a scale
Standard Error 1.32
|
|
Sensory Dimension of McGill Pain Questionnaire
Check up 2
|
4.5 units on a scale
Standard Error 0.68
|
5.4 units on a scale
Standard Error .94
|
5.03 units on a scale
Standard Error 0.88
|
5.5 units on a scale
Standard Error 0.94
|
|
Sensory Dimension of McGill Pain Questionnaire
Check up 3
|
4.72 units on a scale
Standard Error 0.77
|
5.82 units on a scale
Standard Error 1.3
|
5.96 units on a scale
Standard Error 1.19
|
7.07 units on a scale
Standard Error 1.3
|
|
Sensory Dimension of McGill Pain Questionnaire
Check up 4
|
4.71 units on a scale
Standard Error 0.88
|
5.62 units on a scale
Standard Error 0.95
|
8 units on a scale
Standard Error 1.39
|
8.68 units on a scale
Standard Error 1.6
|
PRIMARY outcome
Timeframe: Check Up 1, Check Up 2, Check Up 3, and Check Up 4Participants completed the McGill Pain Questionnaire-short form (MPQ) at Check Up 1, Check Up 2, Check Up 3, and Check Up 4. Check Up 1 \& 2 occurred on Post-Op Day 1. Check Up 1 occurred immediately after surgery. Check Up 2 occurred 4 hours after Check Up 1. Check Up 3 \& 4 occurred on Post-Op Day 2, 4 hours apart. The MPQ has two pain dimensions: 1.Sensory subscale with 11 words, and 2.Affective subscale with 4 words from the original MPQ. The range of scores for the affective dimension of pain is 0-12. The maximum total score for the Affective dimension is 12. Higher scores are indicative of worse pain on the affective dimension of pain.
Outcome measures
| Measure |
Both Real TMS
n=28 Participants
Participants in the Both Real TMS group receive 20 minutes of Real TMS 45 minutes after gastric-bypass surgery and then another 20 minutes of Real TMS 4 hours after surgery.
|
Sham Then Real TMS
n=25 Participants
Participants in the Sham then Real TMS group, receive Sham TMS 45 minutes after gastric-bypass surgery and 20 minutes of Real TMS 4 hours after surgery.
|
Real Then Sham TMS
n=27 Participants
Participants in the Real then Sham TMS group receive 20 minutes of Real TMS 45 minutes after gastric-bypass surgery and then 20 minutes of Sham TMS 4 hours after surgery.
|
Both Sham TMS
n=28 Participants
Participants in the Both Sham TMS group, receive Sham TMS 45 minutes after gastric-bypass surgery and then another 20 minutes of Sham TMS 4 hours after surgery
|
|---|---|---|---|---|
|
Affective Dimension of McGill Pain Questionnaire
Check up 1
|
2.33 units on a scale
Standard Error 0.64
|
0.95 units on a scale
Standard Error 028
|
1.29 units on a scale
Standard Error 0.36
|
1.6 units on a scale
Standard Error 0.4
|
|
Affective Dimension of McGill Pain Questionnaire
Check up 4
|
0.88 units on a scale
Standard Error 0.2
|
1.62 units on a scale
Standard Error 0.43
|
1.86 units on a scale
Standard Error 0.44
|
3 units on a scale
Standard Error 0.76
|
|
Affective Dimension of McGill Pain Questionnaire
Check up 2
|
1.35 units on a scale
Standard Error 0.3
|
1.35 units on a scale
Standard Error 0.4
|
1.64 units on a scale
Standard Error 0.57
|
1.88 units on a scale
Standard Error 0.35
|
|
Affective Dimension of McGill Pain Questionnaire
Check up 3
|
1.08 units on a scale
Standard Error 0.28
|
1.4 units on a scale
Standard Error 0.6
|
1 units on a scale
Standard Error 0.21
|
2.5 units on a scale
Standard Error 0.53
|
SECONDARY outcome
Timeframe: After second TMS treatment (Check up 4)Participants were asked to guess whether they received real or sham TMS after each rTMS session. The results below report the percentage or participants that correctly guessed TMS Condition after the second TMS treatment, 4 hours after surgery.
Outcome measures
| Measure |
Both Real TMS
n=108 Participants
Participants in the Both Real TMS group receive 20 minutes of Real TMS 45 minutes after gastric-bypass surgery and then another 20 minutes of Real TMS 4 hours after surgery.
|
Sham Then Real TMS
Participants in the Sham then Real TMS group, receive Sham TMS 45 minutes after gastric-bypass surgery and 20 minutes of Real TMS 4 hours after surgery.
|
Real Then Sham TMS
Participants in the Real then Sham TMS group receive 20 minutes of Real TMS 45 minutes after gastric-bypass surgery and then 20 minutes of Sham TMS 4 hours after surgery.
|
Both Sham TMS
Participants in the Both Sham TMS group, receive Sham TMS 45 minutes after gastric-bypass surgery and then another 20 minutes of Sham TMS 4 hours after surgery
|
|---|---|---|---|---|
|
Correctly Guessed Assignment Condition at 4 Hours
|
53 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After Second TMS Treatment (Check up 4)After participants guessed their TMS condition; whether they received real or sham TMS, They were then asked to rate the confidence in their guess. Ratings were on a scale of 0-10 where 0=complete guess and 10=absolutely sure. Results below include the mean confidence ratings of those that guessed the TMS condition correctly and those that guessed incorrectly.
Outcome measures
| Measure |
Both Real TMS
n=57 Participants
Participants in the Both Real TMS group receive 20 minutes of Real TMS 45 minutes after gastric-bypass surgery and then another 20 minutes of Real TMS 4 hours after surgery.
|
Sham Then Real TMS
n=51 Participants
Participants in the Sham then Real TMS group, receive Sham TMS 45 minutes after gastric-bypass surgery and 20 minutes of Real TMS 4 hours after surgery.
|
Real Then Sham TMS
Participants in the Real then Sham TMS group receive 20 minutes of Real TMS 45 minutes after gastric-bypass surgery and then 20 minutes of Sham TMS 4 hours after surgery.
|
Both Sham TMS
Participants in the Both Sham TMS group, receive Sham TMS 45 minutes after gastric-bypass surgery and then another 20 minutes of Sham TMS 4 hours after surgery
|
|---|---|---|---|---|
|
Confidence Ratings of Guessing TMS Condition Assignment
|
5.40 units on a scale
Standard Deviation 3.16
|
6.52 units on a scale
Standard Deviation 2.51
|
—
|
—
|
Adverse Events
Both Real TMS
Sham Then Real TMS
Real Then Sham TMS
Both Sham TMS
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
JEFFREY J BORCKARDT
Medical University of South Carolina
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place