Clinical trial NCT01861574: Transcranial Magnetic Stimulation Effects on Pain Perception
Official title: Transcranial Magnetic Stimulation (TMS) Effects on Pain Perception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Bypass Surgery Pain Management
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2013-05-23
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Adult gastric by-pass patients 18 to 60 years old

Exclusion Criteria:

* Non gastric by -pass patients.

Primary outcomes:
measure: Patient Controlled Analgesia (PCA) Hydromorphone Usage
timeFrame: Post-Op Hour 0 through 48
measure: Sensory Dimension of McGill Pain Questionnaire
timeFrame: Check Up 1, Check Up 2, Check Up 3, and Check Up 4
measure: Affective Dimension of McGill Pain Questionnaire
timeFrame: Check Up 1, Check Up 2, Check Up 3, and Check Up 4
Secondary outcomes:
measure: Correctly Guessed Assignment Condition at 4 Hours
timeFrame: After second TMS treatment (Check up 4)
measure: Confidence Ratings of Guessing TMS Condition Assignment
timeFrame: After Second TMS Treatment (Check up 4)
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Institute of Psychiatry Brain Stimulation lab
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Jeffrey Borckardt
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.