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

Study Overview
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Brief Summary
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To determine whether real TMS is more effective than sham TMS in reducing pain following surgery

Detailed Description
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Device: Active Transcranial Magnetic Stimulation
* Device: Sham Transcranial Magnetic Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dental fillings, implants, and bridge work are permitted. - Exclusion Criteria: Metal objects within 30 cm of the brain. These include cochlear implants, stents, vagus nerve stimulators, heart devices, bullet fragments, or jewelry. Monitors, earrings, hearing aids, eyeglasses, jewelry, hair barrettes, cell phones, and digital sound recording device players will be removed. Actively suicidal. Older than 70 years. Seizures, strokes, dementia, or movement disorders. Pregnant or nursing. Permanent makeup with metal ink. Medication known to increase risk of seizures. -
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Transcranial Magnetic Stimulation<br>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. | Device: Active Transcranial Magnetic Stimulation<br>* 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.<br>|
| Sham Comparator: Sham Transcranial Magnetic Stimulation<br>During sham TMS, a coil will be placed on the left prefrontal area of the head. Sham TMS will simulate active treatment as described in active arm. | Device: Sham Transcranial Magnetic Stimulation<br>* Inactive treatment (simulation of active TMS)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily and total mg of opiate pain medication and any other over the counter alternate pain medication. |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Visual Analog Scales daily for mood and pain as well as an initial and final Beck Depression Inventory and Center for Epidemiological Studies 10-item Depression Scale |  | One year |