The TMS Treatment for Postoperative Headache in GH Tumor

Brief Title

The TMS Treatment for Postoperative Headache in GH Tumor

Official Title

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

Brief 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.
    

Study Type

Interventional

Primary Outcome

changes in the degree of headache

Secondary Outcome

 The decrease of using acetaminophen

Condition

Headache

Intervention

Transcranial magnetic stimulation

Study Arms / Comparison Groups

 Simple acetaminophen treatment

Description:  Acetaminophen will be taken when patients suffered from headache during the study. No specific dosage and frequency was required for this group as long as the participants record the exact drug usage.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Device

Estimated Enrollment

200

Start Date

September 1, 2020

Completion Date

September 30, 2022

Primary Completion Date

September 30, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with GH tumor who have undergone transnasal pituitary tumor resection or
             craniotomy for pituitary tumor resection in the past (3 months or more), aged between
             18 and 60 years old, regardless of gender;

               -  Preoperative glucose tolerance test (OGTT) simultaneously determines that the
                  trough value of GH is greater than 1ng/ml, and the level of IGF-1 is greater than
                  the upper limit of the age-sex-matched normal value; ③. Biochemical remission is
                  achieved after surgery, that is, the random GH value is less than 1ng/ml, and the
                  IGF-1 level is within the normal range of age and gender matching; ④. The patient
                  still has headaches after the operation, the duration of each attack is more than
                  4 hours, and the attack is more than 3 times per month; ⑤. The patient is in a
                  headache attack period; ⑥. A clear consciousness, able to understand and sign an
                  informed consent form.

        Exclusion Criteria:

          -  Patients who are being treated with somatostatin and bromocriptine;

               -  Patients with other intracranial organic diseases;

                    -  Pregnant women and children who cannot express;

                         -  Patients with other malignant tumors;

                              -  Participate in other clinical research in the same period; ⑥.
                                 Patients with severe medical complications, such as heart, lung,
                                 kidney, liver and other diseases, severe hypertension or poor
                                 blood pressure control, hyperglycemia, blood diseases;

                                   -  Those with mental illness who cannot cooperate well with the
                                      experiment;

                                        -  Patients with acute infection or open wounds; ⑨.
                                           Acetaminophen is contraindicated (hemolytic anemia,
                                           severe liver and kidney dysfunction) or allergic to its
                                           components; ⑩. Patients with contraindications to
                                           transcranial magnetic stimulation: patients or users who
                                           have implanted cardiac pacemakers, implantable
                                           defibrillators and neurostimulators together; those who
                                           have a history of epilepsy; wear electronic products
                                           (such as insulin Pumps, Holter, etc.).
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

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NCT ID

NCT04529356

Organization ID

KY2020-844

Responsible Party

Principal Investigator

Study Sponsor

Huashan Hospital

Study Sponsor

, , 

Verification Date

August 2020