Gastric Bypass Surgery Pain ManagementTMSNCT01861574
Transcranial Magnetic Stimulation Effects on Pain Perception
A study testing Real TMS 45 min and Real TMS 4 Hours in people with Gastric Bypass Surgery Pain Management, run by Medical University of South Carolina at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gastric Bypass Surgery Pain Management
- What is being tested?
- Real TMS 45 min and Real TMS 4 Hours
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult gastric by-pass patients 18 to 60 years old
Who cannot join
- Non gastric by -pass patients.
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute of Psychiatry Brain Stimulation lab
Charleston, South Carolina, 29425-5712
About this study
Official title: Transcranial Magnetic Stimulation (TMS) Effects on Pain Perception
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)
Read the detailed description
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.
- Conditions
- Gastric Bypass Surgery Pain Management
- Being tested
- Real TMS 45 min, Sham TMS 45 min, Real TMS 4 Hours, Sham TMS 4 Hours
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real TMS 45 minDevice
Also called NeoPulse Neotonus Model 3600
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).
Sham TMS 45 minDevice
Also called NeoPulse Neotonus Model 3600
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.
Real TMS 4 HoursDevice
Also called NeoPulse Neotonus Model 3600
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).
Sham TMS 4 HoursDevice
Also called NeoPulse Neotonus Model 3600
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Real TMS 45 min; Device: Real TMS 4 Hours |
| 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. Receives: Device: Sham TMS 45 min; Device: Real TMS 4 Hours |
| 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. Receives: Device: Real TMS 45 min; Device: Sham TMS 4 Hours |
| 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 Receives: Device: Sham TMS 45 min; Device: Sham TMS 4 Hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: Check Up 1, Check Up 2, Check Up 3, and Check Up 4
Secondary outcomes (2)
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.
Measured: After second TMS treatment (Check up 4)
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.
Measured: After Second TMS Treatment (Check up 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startFeb 2005
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric Bypass Surgery Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Borckardt, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861574
- Sponsor's protocol ID
- HR 15330
- Acronym
- TMS
- Status last verified
- Aug 2018
- First submitted
- 26 Apr 2012
- Last updated
- 27 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24527503
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation (TMS) Effects on Pain Perception
- ClinicalTrials.gov ID
- NCT01861574
- Acronym / sponsor ID
- TMS / HR 15330
- Conditions
- Gastric Bypass Surgery Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 23 May 2013 (estimated)
- Results
- Posted 23 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Both Real TMS | Experimental | Device: Real TMS 45 min, Device: Real TMS 4 HoursParticipants 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 | Sham comparator | Device: Sham TMS 45 min, Device: Real TMS 4 HoursParticipants 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 | Sham comparator | Device: Real TMS 45 min, Device: Sham TMS 4 HoursParticipants 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 | Sham comparator | Device: Sham TMS 45 min, Device: Sham TMS 4 HoursParticipants 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult gastric by-pass patients 18 to 60 years old
Key exclusion criteria (1 listed)
- Non gastric by -pass patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real TMS 45 minAlso: NeoPulse Neotonus Model 3600Real 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). | Device | Both Real TMS, Real then Sham TMS |
| Sham TMS 45 minAlso: NeoPulse Neotonus Model 3600Sham 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. | Device | Both Sham TMS, Sham then Real TMS |
| Real TMS 4 HoursAlso: NeoPulse Neotonus Model 3600Real 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). | Device | Both Real TMS, Sham then Real TMS |
| Sham TMS 4 HoursAlso: NeoPulse Neotonus Model 3600Sham 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. | Device | Both Sham TMS, Real then Sham TMS |
Primary outcome
Patient Controlled Analgesia (PCA) Hydromorphone Usage
Time frame: Post-Op Hour 0 through 48
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).
Sensory Dimension of McGill Pain Questionnaire
Time frame: Check Up 1, Check Up 2, Check Up 3, and Check Up 4
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.
Affective Dimension of McGill Pain Questionnaire
Time frame: Check Up 1, Check Up 2, Check Up 3, and Check Up 4
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.
2 secondary outcomes
Correctly Guessed Assignment Condition at 4 Hours
Time frame: After second TMS treatment (Check up 4)
Confidence Ratings of Guessing TMS Condition Assignment
Time frame: After Second TMS Treatment (Check up 4)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24527503Borckardt 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.
- Link to Published Manuscript for NCT01861574 (HR 15330)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Borckardt principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real TMS 45 min and Real TMS 4 Hours in people with Gastric Bypass Surgery Pain Management, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Controlled Analgesia (PCA) Hydromorphone Usage (time frame: Post-Op Hour 0 through 48). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01861574, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2018.