NCT04529356

The TMS Treatment for Postoperative Headache in GH Tumor

A Randomized Controlled Study of Transcranial Magnetic Stimulation for Postoperative Headache in Patients With Growth Hormone（GH） Pituitary Tumor

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Headache is a very common main complaint of patients with GH pituitary tumor, which has seriously affected the normal work and life of patients. Although the current surgery and drugs have a certain effect on patients with headache, the overall effect is not satisfied. However, the use of COX-2 inhibitors, non-steroidal anti-inflammatory drugs and other analgesics are only effective for some patients with headaches, and long-term use has adverse reactions. Therefore, it is necessary to seek new treatments for postoperative headaches in patients with GH pituitary tumors. Transcranial magnetic stimulation (TMS) modulates the excitability of the underlying cerebral cortex by applying a rapidly changing magnetic field on the surface of the scalp. It is a relatively simple and safe method. It is currently approved for treating depression, migraine, obsessive-compulsive disorder, and Alzheimer's disease. Several small clinical studies have proven that rTMS can be used to prevent and treat Headache. Therefore, this study aims to observe the efficacy and safety of TMS in the treatment of postoperative headache in patients with GH pituitary tumors.

Conditions

• Headache
• Pituitary Tumor
• Acromegaly

Interventions

Type	Name	Description
DEVICE	Transcranial magnetic stimulation	By using different frequency of TMS, the device can generate different effects. For low frequency, such as 1HZ, it mainly generates inhibition on the brain cortex; while high frequency (usually higher than 10HZ) can generate stimulation effects. The later one could be used to treat different central nervous disease.
DRUG	Acetaminophen	Acetaminophen is used as the painkiller to alleviate patients' headache before and during the clinical trial. In order to decrease the medication bias, we required these patients to only use acetaminophen instead of other non-steroid anti-inflammatory drugs. In the meantime, participants are requested to recorder the frequency and dosage of acetaminophen they used during the treatment course.

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-09-30
• Completion: 2022-09-30
• First posted: 2020-08-27
• Last updated: 2020-08-27