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

East Tennessee State University

Status: Withdrawn

Conditions: Pain

Treatments: Device: Active Transcranial Magnetic Stimulation; Device: Sham Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02521480

0615.11f

Details and patient eligibility

About

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

Full 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.

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 2 patient groups

Active Transcranial Magnetic Stimulation

Active Comparator group

Description:

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.

Treatment:

Device: Active Transcranial Magnetic Stimulation

Sham Transcranial Magnetic Stimulation

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Transcranial Magnetic Stimulation