- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02521480
Determination of Analgesic Effect From One Transcranial Magnetic Stimulation(TMS)Treatment Following Vaginal Reconstructive Surgery. (TMS)
Determination of the Analgesic Effects of One Session of Postoperative Left Prefrontal Cortex Repetitive Transcranial Magnetic Stimulation (TMS) Following Vaginal Reconstructive Surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tennessee
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Johnson City, Tennessee, United States, 37604
- ETSU Dept. of Psychiatry
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
---|---|
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.
|
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.
|
Inactive treatment (simulation of active TMS)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Daily and total mg of opiate pain medication and any other over the counter alternate pain medication.
Time Frame: One year
|
One year
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Secondary Outcome Measures
Outcome Measure |
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
Time Frame: One year
|
One year
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 0615.11f
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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