HeadacheNCT04529356
The TMS Treatment for Postoperative Headache in GH Tumor
A study testing Transcranial magnetic stimulation and Acetaminophen in people with Headache and Pituitary Tumor, run by Huashan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache, Pituitary Tumor, Acromegaly
- What is being tested?
- Transcranial magnetic stimulation and Acetaminophen
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.).
About this study
Official title: A Randomized Controlled Study of Transcranial Magnetic Stimulation for Postoperative Headache in Patients With Growth Hormone（GH） Pituitary Tumor
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
- Being tested
- Transcranial magnetic stimulation, Acetaminophen
- Medical subject headings
- Headache, Pituitary Neoplasms, Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulationDevice
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.
AcetaminophenDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Simple acetaminophen treatment | Sham comparator | 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. Receives: Drug: Acetaminophen |
| Simple acetaminophen combined with low-frequency rTMS | Active comparator | Apart from acetaminophen usage, low frequency TMS (1HZ) will be used in patients three times a month for 6 months. Receives: Device: Transcranial magnetic stimulation; Drug: Acetaminophen |
| Simple acetaminophen combined with high-frequency rTMS | Experimental | Apart from acetaminophen usage, high frequency TMS (10HZ) will be used in patients three times a month for 6 months. Receives: Device: Transcranial magnetic stimulation; Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
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
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoyun Zhang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529356
- Sponsor's protocol ID
- KY2020-844
- Status last verified
- Aug 2020
- First submitted
- 7 Aug 2020
- Last updated
- 27 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Transcranial Magnetic Stimulation for Postoperative Headache in Patients With Growth Hormone（GH） Pituitary Tumor
- ClinicalTrials.gov ID
- NCT04529356
- Acronym / sponsor ID
- KY2020-844
- Conditions
- Headache, Pituitary Tumor, Acromegaly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Simple acetaminophen treatment | Sham comparator | Drug: AcetaminophenAcetaminophen 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. |
| Simple acetaminophen combined with low-frequency rTMS | Active comparator | Device: Transcranial magnetic stimulation, Drug: AcetaminophenApart from acetaminophen usage, low frequency TMS (1HZ) will be used in patients three times a month for 6 months. |
| Simple acetaminophen combined with high-frequency rTMS | Experimental | Device: Transcranial magnetic stimulation, Drug: AcetaminophenApart from acetaminophen usage, high frequency TMS (10HZ) will be used in patients three times a month for 6 months. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (7 listed)
- Patients who are being treated with somatostatin and bromocriptine;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial magnetic stimulationBy 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. | Device | Simple acetaminophen combined with high-frequency rTMS, Simple acetaminophen combined with low-frequency rTMS |
| AcetaminophenAcetaminophen 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. | Drug | Simple acetaminophen combined with high-frequency rTMS, Simple acetaminophen combined with low-frequency rTMS, Simple acetaminophen treatment |
Primary outcome
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
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
1 secondary outcome
The decrease of using acetaminophen
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnetic stimulation and Acetaminophen in people with Headache and Pituitary Tumor, run by Huashan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in the degree of headache (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2020.