Determination of Analgesic Effect From One Transcranial Magnetic Stimulation(TMS)Treatment Following Vaginal Reconstructive Surgery. (TMS)
March 7, 2016 updated by: Dr. Norman Moore, East Tennessee State University
Determination of the Analgesic Effects of One Session of Postoperative Left Prefrontal Cortex Repetitive Transcranial Magnetic Stimulation (TMS) Following Vaginal Reconstructive Surgery.
To determine whether real TMS is more effective than sham TMS in reducing pain following surgery
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tennessee
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Johnson City, Tennessee, United States, 37604
- ETSU Dept. of Psychiatry
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: 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.
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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.
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Sham Comparator: 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.
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Inactive treatment (simulation of active TMS)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Daily and total mg of opiate pain medication and any other over the counter alternate pain medication.
Time Frame: One year
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One year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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
Time Frame: One year
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One year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Anticipated)
July 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
August 10, 2015
First Submitted That Met QC Criteria
August 10, 2015
First Posted (Estimate)
August 13, 2015
Study Record Updates
Last Update Posted (Estimate)
March 8, 2016
Last Update Submitted That Met QC Criteria
March 7, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 0615.11f
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