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The purpose of this research study is to investigate the effects of Transcranial Magnetic Stimulation on pain perception. TMS is a non - invasive technique that uses electromagnetic pulses to temporarily stimulate specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures)
To test whether rTMS over the left prefrontal cortex significantly reduces post-operative pain and PCA use following gastric-bypass surgery relative to sham and an active control, in a mood- independent manner. Note that the active control is still mentioned in the aims and hypotheses, but was apparently removed from the study design.
To determine the effects of timing (one immediately following surgery and one 4 hours later) and dose of TMS (0, 1, or 2 sessions of active rTMS) on post-operative pain and PCA use; To determine the effects of TMS on post-surgical recovery time (time to discharge) and clinical outcomes at 1-month, 3- months and 6-months follow-up. Again an active control is mentioned, though this was removed from the design. It appears that this aspect of the proposal was not edited to reflect the new study design.
In the new design, 108 participants received two 20 minute sessions of 10 Hz rTMS (110% of motor threshold) over the left dorsolateral prefrontal cortex (one immediately following surgery and one 4 hours later). Participants were randomly assigned to receive two sessions of real rTMS, two sessions of sham, 1 real then 1 sham, or 1 sham then 1 real rTMS treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Both Real TMS | Experimental | 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. |
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| Sham then Real TMS | Sham Comparator | 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. |
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| Real then Sham TMS | Sham Comparator | 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. |
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| Both Sham TMS | Sham Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real TMS 45 min | Device | Real TMS 45 minutes after surgery, first determined resting motor threshold (rMT) by starting with 40% of the machine output and 0.5 Hz stimulus frequency. The coil was positioned over the motor cortex and then adjusted until each pulse results in movement of the right thumb. The machine output was then adjusted to the lowest intensity that reliably produces thumb movement. Parameter estimation by sequential testing was used to determine the amount of machine energy necessary to visibly move the thumb 50% of the time. rMT was assessed before each rTMS treatment. The left prefrontal cortex was the cortical target for rTMS treatment. The EEG-10-20 system was used to locate the prefrontal cortex (F3). |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Controlled Analgesia (PCA) Hydromorphone Usage | 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). | Post-Op Hour 0 through 48 |
| Sensory Dimension of McGill Pain Questionnaire | Participants 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. | Check Up 1, Check Up 2, Check Up 3, and Check Up 4 |
| Affective Dimension of McGill Pain Questionnaire | Participants 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. | Check Up 1, Check Up 2, Check Up 3, and Check Up 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Correctly Guessed Assignment Condition at 4 Hours | 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. | After second TMS treatment (Check up 4) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Borckardt | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Psychiatry Brain Stimulation lab | Charleston | South Carolina | 29425-5712 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24527503 | Result | Borckardt JJ, Reeves ST, Kotlowski P, Abernathy JH, Field LC, Dong L, Frohman H, Moore H, Ryan K, Madan A, George MS. Fast left prefrontal rTMS reduces post-gastric bypass surgery pain: findings from a large-scale, double-blind, sham-controlled clinical trial. Brain Stimul. 2014 Jan-Feb;7(1):42-8. doi: 10.1016/j.brs.2013.07.007. |
| Label | URL |
|---|---|
| Link to Published Manuscript for NCT01861574 (HR 15330) | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Sham Then Real TMS |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Controlled Analgesia (PCA) Hydromorphone Usage | 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). | Posted | Mean | Standard Deviation | mg/ml | Post-Op Hour 0 through 48 |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| JEFFREY J BORCKARDT | Medical University of South Carolina | (843)792-3295 | borckard@musc.edu |
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| Sham TMS 45 min | Device | Sham TMS 45 minutes after surgery used specifically designed rTMS coil that produces auditory signals identical to real (active) TMS coils but is shielded so that actual stimulation does not occur. The eSham system was used to mimic sensations of real rTMS. This system produces mild tingling on the scalp underneath the sham rTMS coil, making it difficult in differentiating between real and sham. The amount of electrical stimulation necessary to match real rTMS pulses was determined using an algorithm (parameter estimation by sequential testing). All subjects underwent the sham titration at the beginning of every rTMS session regardless of group assignment. The left prefrontal cortex was the cortical target for rTMS treatment, located using the EEG-10-20 system. |
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| Real TMS 4 Hours | Device | Real TMS 4 hours after surgery, first determined resting motor threshold (rMT) by starting with 40% of the machine output and 0.5 Hz stimulus frequency. The coil was positioned over the motor cortex and then adjusted until each pulse results in movement of the right thumb. The machine output was then adjusted to the lowest intensity that reliably produces thumb movement. Parameter estimation by sequential testing was used to determine the amount of machine energy necessary to visibly move the thumb 50% of the time. rMT was assessed before each rTMS treatment. The left prefrontal cortex was the cortical target for rTMS treatment. The EEG-10-20 system was used to locate the prefrontal cortex (F3). |
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| Sham TMS 4 Hours | Device | Sham TMS 4 hours after surgery used specifically designed rTMS coil that produces auditory signals identical to real (active) TMS coils but is shielded so that actual stimulation does not occur. The eSham system was used to mimic sensations of real rTMS. This system produces mild tingling on the scalp underneath the sham rTMS coil, making it difficult in differentiating between real and sham. The amount of electrical stimulation necessary to match real rTMS pulses was determined using an algorithm (parameter estimation by sequential testing). All subjects underwent the sham titration at the beginning of every rTMS session regardless of group assignment. The left prefrontal cortex was the cortical target for rTMS treatment, located using the EEG-10-20 system. |
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| Confidence Ratings of Guessing TMS Condition Assignment |
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. |
| After Second TMS Treatment (Check up 4) |
Gastric-Bypass Patients receive Sham TMS 45 minutes after gastric-bypass surgery Gastric-Bypass Patients receive Real TMS 4 hours after gastric-bypass surgery
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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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. |
| OG002 | 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. |
| OG003 | 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 |
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| Primary | Sensory Dimension of McGill Pain Questionnaire | Participants 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. | Posted | Mean | Standard Error | units on a scale | Check Up 1, Check Up 2, Check Up 3, and Check Up 4 |
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| Secondary | Correctly Guessed Assignment Condition at 4 Hours | 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. | Posted | Number | percentage of participants | After second TMS treatment (Check up 4) |
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| Secondary | Confidence Ratings of Guessing TMS Condition Assignment | 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. | Posted | Mean | Standard Deviation | units on a scale | After Second TMS Treatment (Check up 4) |
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| Primary | Affective Dimension of McGill Pain Questionnaire | Participants 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. | Posted | Mean | Standard Error | units on a scale | Check Up 1, Check Up 2, Check Up 3, and Check Up 4 |
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| 28 |
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| 28 |
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| 28 |
| EG001 | 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 | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | 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 | 0 | 27 | 0 | 27 | 0 | 27 |
| EG003 | 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 | 0 | 28 | 0 | 28 | 0 | 28 |
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| Check up 2 |
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| Check up 3 |
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| Check up 4 |
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| Check up 2 |
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| Check up 3 |
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| Check up 4 |
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