NCT02521480

Determination of Analgesic Effect From One Transcranial Magnetic Stimulation(TMS)Treatment Following Vaginal Reconstructive Surgery.

Determination of the Analgesic Effects of One Session of Postoperative Left Prefrontal Cortex Repetitive Transcranial Magnetic Stimulation (TMS) Following Vaginal Reconstructive Surgery.

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: East Tennessee State University · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

To determine whether real TMS is more effective than sham TMS in reducing pain following surgery

Detailed description

To determine the amount of opiate and pain medication administered in the week following surgery. Subjects will receive an identical pain control regimen. Participants will undergo TMS motor threshold assessment at the ETSU Innovation Lab prior to the planned surgery. At this appointment a baseline Beck Depression Inventory (BDI), Center for Epidemiological Studies 10-item Depression scale (CES-D) and visual analog scale (VAS) ratings of pain and mood will be obtained.VAS ratings will also be done each evening over the following week. One day after surgery, the subject will return to the Innovation lab for TMS. A total of 22 subjects will be recruited for the study. At the return visit, 11 will receive 40 minutes of 10 Hz repetitive TMS at 120% of rMT (4-second stimulation trains with 26-second interstimulus intervals). The other 11 participants will receive sham treatment under identical settings. Participants, medical staff providing clinical care to patients and raters will not know whether participants receive real or sham TMS. Patients will keep a log of pain medications used over the following week in addition to the VAS ratings. Follow-up will occur one week after the TMS therapy. The subject will turn in logs and repeat BDI and CES-D scales.

Conditions

• Pain

Interventions

Type	Name	Description
DEVICE	Active Transcranial Magnetic Stimulation	TMS is a non-invasive treatment. During TMS treatment, a coil, which creates a magnetic field, will be placed on the left prefrontal area of the head. Active TMS will stimulate for 4 seconds, pause for 26 seconds, and repeat this for approximately 40 minutes. There will be a total of 3000 pulses during treatment. We expect TMS to decrease pain and depression. In order to find out if this is true, we will compare real TMS with sham (inactive) TMS.This will allow us to decide if active TMS is successful because of electrical stimulation, or because of the support, concern, and understanding of the research team.
DEVICE	Sham Transcranial Magnetic Stimulation	Inactive treatment (simulation of active TMS)

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-07-01
• Completion: 2016-12-01
• First posted: 2015-08-13
• Last updated: 2016-03-08

Locations

1 site across 1 country: United States