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

Not Applicable

Withdrawn

• Conditions: Pain
• Interventions: Device: Active Transcranial Magnetic Stimulation; Device: Sham Transcranial Magnetic Stimulation

• Registration Number: NCT02521480
• Lead Sponsor: East Tennessee State University

Brief 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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-08-10
• Study First Submitted QC: 2015-08-10
• Study First Posted: 2015-08-13
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-07
• Last Update Posted: 2016-03-08
• Primary Completion: 2016-07
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Transcranial Magnetic Stimulation	Active Transcranial Magnetic Stimulation	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.
Sham Transcranial Magnetic Stimulation	Sham Transcranial Magnetic Stimulation	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.

Primary Outcome Measures

Name	Time	Method
Daily and total mg of opiate pain medication and any other over the counter alternate pain medication.	One year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

ETSU Dept. of Psychiatry; 🇺🇸 Johnson City, Tennessee, United States