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临床试验/NCT02521480
NCT02521480撤回不适用

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

East Tennessee State University1 个研究点 分布在 1 个国家开始时间: 2015年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Daily and total mg of opiate pain medication and any other over the counter alternate pain medication.

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

性别
Female
接受健康志愿者
否

入选标准

  • •Dental fillings, implants, and bridge work are permitted. -

排除标准

  • •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.

研究组 & 干预措施

Active Transcranial Magnetic Stimulation

Active Comparator

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.

干预措施: Active Transcranial Magnetic Stimulation (Device)

Sham Transcranial Magnetic Stimulation

Sham Comparator

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.

干预措施: Sham Transcranial Magnetic Stimulation (Device)

结局指标

主要结局

Daily and total mg of opiate pain medication and any other over the counter alternate pain medication.

时间窗: One year

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Norman Moore

Norman Moore, M.D.

East Tennessee State University

研究点 (1)

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