Transcranial Magnetic Stimulation Effects on Pain Perception (TMS)

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Gastric Bypass Surgery Pain Management

Treatments: Device: Sham TMS 4 Hours; Device: Real TMS 45 min; Device: Sham TMS 45 min; Device: Real TMS 4 Hours

Study type: Interventional

Funder types: Other

Identifiers

NCT01861574

HR 15330

Details and patient eligibility

About

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)

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Non gastric by -pass patients.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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108 participants in 4 patient groups

Both Real TMS

Experimental group

Description:

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.

Treatment:

Device: Real TMS 4 Hours

Device: Real TMS 45 min

Sham then Real TMS

Sham Comparator group

Description:

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.

Treatment:

Device: Real TMS 4 Hours

Device: Sham TMS 45 min

Real then Sham TMS

Sham Comparator group

Description:

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.

Treatment:

Device: Real TMS 45 min

Device: Sham TMS 4 Hours

Both Sham TMS

Sham Comparator group

Description:

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

Treatment:

Device: Sham TMS 45 min

Device: Sham TMS 4 Hours