Study Stopped
Study not feasible or convenient for the subject
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.
1 other identifier
interventional
N/A
1 country
1
Brief Summary
To determine whether real TMS is more effective than sham TMS in reducing pain following surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2015
Typical duration for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 10, 2015
CompletedFirst Posted
Study publicly available on registry
August 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMarch 8, 2016
March 1, 2016
1 year
August 10, 2015
March 7, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Daily and total mg of opiate pain medication and any other over the counter alternate pain medication.
One year
Secondary Outcomes (1)
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
Study Arms (2)
Active Transcranial Magnetic Stimulation
ACTIVE COMPARATORDuring 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 COMPARATORDuring 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.
Interventions
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.
Inactive treatment (simulation of active TMS)
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- East Tennessee State Universitylead
- Neuroneticscollaborator
Study Sites (1)
ETSU Dept. of Psychiatry
Johnson City, Tennessee, 37604, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Norman Moore, M.D.
Study Record Dates
First Submitted
August 10, 2015
First Posted
August 13, 2015
Study Start
July 1, 2015
Primary Completion
July 1, 2016
Study Completion
December 1, 2016
Last Updated
March 8, 2016
Record last verified: 2016-03