Back to resultsThe TMS Treatment for Postoperative Headache in GH Tumor
Primary Purpose
Headache, Pituitary Tumor, Acromegaly
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcranial magnetic stimulation
Acetaminophen
Sponsored by
About this trial
This is an interventional treatment trial for Headache
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.).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Sham Comparator
Active Comparator
Experimental
Arm Label
Simple acetaminophen treatment
Simple acetaminophen combined with low-frequency rTMS
Simple acetaminophen combined with high-frequency rTMS
Arm 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.
Apart from acetaminophen usage, low frequency TMS (1HZ) will be used in patients three times a month for 6 months.
Apart from acetaminophen usage, high frequency TMS (10HZ) will be used in patients three times a month for 6 months.
Outcomes
Primary Outcome Measures
changes in the degree of headache
The degree of headache will be measured by the Visual Analog Scale VAS and the scores change before and after 6 months of intervention will be compared among 3 groups
the improvement of quality of life(QOL)
Migraine Defect Assessment Questionnaire MIDAS will be used to evaluate QOL. The QOL will be assessed before and after 6 months of intervention and the changes of MIDAS scores will be compared among 3 groups
Secondary Outcome Measures
The decrease of using acetaminophen
During the experiment, patients will be required to record the dosage of acetaminophen they used. Our anticipated secondary outcome is the decreased usage of painkiller in the rTMS treated patients.The total dosage of acetaminophen used in 1st month and the 6th month during the study will be recorded and the changes of the dosage will be compared among the 3 groups.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04529356
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Pituitary Tumor, Acromegaly
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Simple acetaminophen treatment
Arm Type
Sham Comparator
Arm 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.
Arm Title
Simple acetaminophen combined with low-frequency rTMS
Arm Type
Active Comparator
Arm Description
Apart from acetaminophen usage, low frequency TMS (1HZ) will be used in patients three times a month for 6 months.
Arm Title
Simple acetaminophen combined with high-frequency rTMS
Arm Type
Experimental
Arm Description
Apart from acetaminophen usage, high frequency TMS (10HZ) will be used in patients three times a month for 6 months.
Intervention Type
Device
Intervention Name(s)
Transcranial magnetic stimulation
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
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.
Primary Outcome Measure Information:
Title
changes in the degree of headache
Description
The degree of headache will be measured by the Visual Analog Scale VAS and the scores change before and after 6 months of intervention will be compared among 3 groups
Time Frame
6 months
Title
the improvement of quality of life(QOL)
Description
Migraine Defect Assessment Questionnaire MIDAS will be used to evaluate QOL. The QOL will be assessed before and after 6 months of intervention and the changes of MIDAS scores will be compared among 3 groups
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The decrease of using acetaminophen
Description
During the experiment, patients will be required to record the dosage of acetaminophen they used. Our anticipated secondary outcome is the decreased usage of painkiller in the rTMS treated patients.The total dosage of acetaminophen used in 1st month and the 6th month during the study will be recorded and the changes of the dosage will be compared among the 3 groups.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.).
12. IPD Sharing Statement
Learn more about this trial
The TMS Treatment for Postoperative Headache in GH Tumor
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