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The TMS Treatment for Postoperative Headache in GH Tumor

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ClinicalTrials.gov Identifier: NCT04529356
Recruitment Status : Not yet recruiting
First Posted : August 27, 2020
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
Zhaoyun Zhang, Huashan Hospital

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.

Condition or disease Intervention/treatment Phase
Headache Pituitary Tumor Acromegaly Device: Transcranial magnetic stimulation Drug: Acetaminophen Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of Transcranial Magnetic Stimulation for Postoperative Headache in Patients With Growth Hormone(GH) Pituitary Tumor
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2022


Arm Intervention/treatment
Sham Comparator: Simple acetaminophen treatment
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.
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.

Active Comparator: Simple acetaminophen combined with low-frequency rTMS
Apart from acetaminophen usage, low frequency TMS (1HZ) will be used in patients three times a month for 6 months.
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.

Experimental: Simple acetaminophen combined with high-frequency rTMS
Apart from acetaminophen usage, high frequency TMS (10HZ) will be used in patients three times a month for 6 months.
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.




Primary Outcome Measures :
  1. changes in the degree of headache [ Time Frame: 6 months ]
    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

  2. the improvement of quality of life(QOL) [ Time Frame: 6 months ]
    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 :
  1. The decrease of using acetaminophen [ Time Frame: 6 months ]
    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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.).
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Responsible Party: Zhaoyun Zhang, professor, Huashan Hospital
ClinicalTrials.gov Identifier: NCT04529356    
Other Study ID Numbers: KY2020-844
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acromegaly
Pituitary Neoplasms
Pituitary Diseases
Headache
Pain
Neurologic Manifestations
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics