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

Pain Clinical Trial

— TMS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02521480
• Other study ID #: 0615.11f
• Status: Withdrawn
• Phase: N/A
• First received: August 10, 2015
• Last updated: March 7, 2016
• Start date: July 2015
• Est. completion date: December 2016

Study information

• Verified date: March 2016
• Source: East Tennessee State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To determine whether real TMS is more effective than sham TMS in reducing pain following surgery

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• Active Transcranial Magnetic Stimulation
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.
• Sham Transcranial Magnetic Stimulation
Inactive treatment (simulation of active TMS)

Locations

Country	Name	City	State
United States	ETSU Dept. of Psychiatry	Johnson City	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
East Tennessee State University	Neuronetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily and total mg of opiate pain medication and any other over the counter alternate pain medication.		One year	No
Secondary	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	No