Chronic MigraineNCT03568617
rTMS for the Prevention Treatment of CM: a Single Arm Study
A study testing rTMS in people with Chronic Migraine, run by Peking Union Medical College Hospital.
Trial summary
We design this pilot, single arm study to explore the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) for the treatment of chronic migraine. The hypothetical control group is pooled sham group in latest meta-analysis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Migraine
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2018to 30 Jun 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects meeting the diagnostic criteria for chronic migraine according to the International Classification of Headache Disorders, 3rd edition.
- The duration of chronic migraine ≥ 6 months.
- age range of 18 - 65 years old
Who cannot join
- Secondary headaches except MOH
- any change of the prophylaxis or the analgesic drug strategy during the baseline and follow-up period
- structural brain lesions
- seizures
- severe systemic disease
- TMS contraindications (such as metal implants)
Show all 11Show fewer
- psychosis
- severe depression or anxiety
- drug or alcohol dependence
- pregnancy
- participating in other experiments at the same time
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Repetitive Transcranial Magnetic Stimulation for the Prevention Treatment of Chronic Migraine: a Single Arm Study
We design this pilot, single arm study to explore the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) for the treatment of chronic migraine. The hypothetical control group is pooled sham group in latest meta-analysis. We expect a significant improvement of the outcome measures during and after the treatment as compared to the hypothetical control group.
Read the detailed description
After a 28-day prospective baseline period using a headache diary to record headache symptoms and any abortive medications used, subjects who meet diagnostic criteria for chronic migraine and don't meet the exclusion criteria will receive rTMS for 4 weeks. The outcome measure will be evaluated at 4 weeks. During the whole trial period, any adverse events are requested to be recorded in the headache diary for analyses. The primary outcome is 50% reduction in the number of days with headache. 50% reduction as assessed by migraine days, moderate/severe headache days, the mean VRS, and conversion to episodic migraine, SGIC, the change from baseline HALT-28, HIT-6, and MSQ v2.1, are used as secondary outcome measures for exploring other benefits associated with treatment.
- Conditions
- Chronic Migraine
- Being tested
- rTMS
- Keywords
- Transcranial Magnetic Stimulation, Migraine Disorders, Prophylaxis, Treatment Outcome, Brain
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
The subjects will receive 20 trains of 100 stimuli each delivered at 10 Hz and 80% of MT over the left MC (M1), 3 days a week, for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| rTMS group | Experimental | Not described Receives: Device: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
50% reduction in the Number of Days with Headache
A Headache day is defined as a day with a headache that lasts at least 4 hours.
Measured: at 4 weeks
Secondary outcomes (8)
50% reduction in the Number of Migraine Days
A migraine day is defined as a day with a headache that lasts at least 4 hours; meets ICHD-III criteria C and D for migraine without aura (1.1), B and C for migraine with aura (1.2), or ICHD-III criteria for probable migraine (1.6); or a day with a headache that is successfully treated with a triptan, ergotamine, or other migraine-specific acute medication.
Measured: at 4 weeks
50% reduction in the Number of Moderate/Severe Headache Days
A moderate/severe headache day is defined as a day with moderate or severe pain that lasts at least 4 hours or a day with a headache that is successfully treated by an acute headache medication.
Measured: at 4 weeks
Conversion to episodic migraine
Defined as the proportion of subjects with fewer than 14 migraine or headache days per 4 weeks.
Measured: at 4 weeks
The Subject's Global Impression of Change (SGIC)
Global impression of change was scored using a 7-point scale for each instrument, ranging from 1 (very much improved) to 7 (very much worse), with a 4-week recall period. We'll estimate the proportion of patients who reported any improved (very much improved, much improved, minimally improved).
Measured: at 4 weeks
Change from Baseline HALT-28 (Headache-Attributed Lost Time - 28 days)
HALT-30 is closely based on the first five questions of MIDAS, developed by RB Lipton and WF Stewart. We modify the time interval to capture migraine-related disability with a 4-week recall period.
Measured: at baseline and 4 weeks
Change from Baseline HIT-6 (Headache Impact Test-6)
HIT-6 is for capturing migraine-related disability with a 4-week recall period.
Measured: at baseline and 4 weeks
Change from Baseline MSQ v2.1 (the Migraine-Specific Quality of Life questionnaire v2.1)
To evaluate the change in quality of life related to chronic migraine with a 4-week recall period.
Measured: at baseline and 4 weeks
50% reduction as assessed by the mean VRS
Subjects will be instructed to record the pain intensity of each day using 11-point Visual Rating Scale (VRS). The mean VRS is defined as the mean of the maximum VRS of each day with a 4-week period.
Measured: at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start30 Jun 2018 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic MigraineStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568617
- Sponsor's protocol ID
- rTMSCM-PUMCH
- Status last verified
- Jun 2018
- First submitted
- 4 Jun 2018
- Last updated
- 26 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lan L, Zhang X, Li X, Rong X, Peng Y. The efficacy of transcranial magnetic stimulation on migraine: a meta-analysis of randomized controlled trails. J Headache Pain. 2017 Aug 22;18(1):86. doi: 10.1186/s10194-017-0792-4.
PubMed 28831756Shehata HS, Esmail EH, Abdelalim A, El-Jaafary S, Elmazny A, Sabbah A, Shalaby NM. Repetitive transcranial magnetic stimulation versus botulinum toxin injection in chronic migraine prophylaxis: a pilot randomized trial. J Pain Res. 2016 Oct 7;9:771-777. doi: 10.2147/JPR.S116671. eCollection 2016.
PubMed 27785091Tassorelli C, Diener HC, Dodick DW, Silberstein SD, Lipton RB, Ashina M, Becker WJ, Ferrari MD, Goadsby PJ, Pozo-Rosich P, Wang SJ; International Headache Society Clinical Trials Standing Committee. Guidelines of the International Headache Society for controlled trials of preventive treatment of chronic migraine in adults. Cephalalgia. 2018 Apr;38(5):815-832. doi: 10.1177/0333102418758283. Epub 2018 Mar 4.
PubMed 29504482Steiner TJ, Lipton RB; Lifting The Burden: The Global Campaign against Headache. The Headache-Attributed Lost Time (HALT) Indices: measures of burden for clinical management and population-based research. J Headache Pain. 2018 Feb 2;19(1):12. doi: 10.1186/s10194-018-0837-3.
PubMed 29396646
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation for the Prevention Treatment of Chronic Migraine: a Single Arm Study
- ClinicalTrials.gov ID
- NCT03568617
- Acronym / sponsor ID
- rTMSCM-PUMCH
- Conditions
- Chronic Migraine
- Keywords
- Transcranial Magnetic Stimulation, Migraine Disorders, Prophylaxis, Treatment Outcome, Brain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 30 Jun 2018 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 26 Jun 2018 (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.
We design this pilot, single arm study to explore the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) for the treatment of chronic migraine. The hypothetical control group is pooled sham group in latest meta-analysis. We expect a significant improvement of the outcome measures during and after the treatment as compared to the hypothetical control group.
Detailed description
After a 28-day prospective baseline period using a headache diary to record headache symptoms and any abortive medications used, subjects who meet diagnostic criteria for chronic migraine and don't meet the exclusion criteria will receive rTMS for 4 weeks. The outcome measure will be evaluated at 4 weeks. During the whole trial period, any adverse events are requested to be recorded in the headache diary for analyses. The primary outcome is 50% reduction in the number of days with headache. 50% reduction as assessed by migraine days, moderate/severe headache days, the mean VRS, and conversion to episodic migraine, SGIC, the change from baseline HALT-28, HIT-6, and MSQ v2.1, are used as secondary outcome measures for exploring other benefits associated with treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rTMS group | Experimental | Device: rTMS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects meeting the diagnostic criteria for chronic migraine according to the International Classification of Headache Disorders, 3rd edition.
- The duration of chronic migraine ≥ 6 months.
- age range of 18 - 65 years old
Key exclusion criteria (11 listed)
- Secondary headaches except MOH
- any change of the prophylaxis or the analgesic drug strategy during the baseline and follow-up period
- structural brain lesions
- seizures
- severe systemic disease
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 |
|---|---|---|
| rTMSThe subjects will receive 20 trains of 100 stimuli each delivered at 10 Hz and 80% of MT over the left MC (M1), 3 days a week, for 4 weeks. | Device | rTMS group |
Primary outcome
50% reduction in the Number of Days with Headache
Time frame: at 4 weeks
A Headache day is defined as a day with a headache that lasts at least 4 hours.
8 secondary outcomes
50% reduction in the Number of Migraine Days
Time frame: at 4 weeks
50% reduction in the Number of Moderate/Severe Headache Days
Time frame: at 4 weeks
Conversion to episodic migraine
Time frame: at 4 weeks
The Subject's Global Impression of Change (SGIC)
Time frame: at 4 weeks
Change from Baseline HALT-28 (Headache-Attributed Lost Time - 28 days)
Time frame: at baseline and 4 weeks
Change from Baseline HIT-6 (Headache Impact Test-6)
Time frame: at baseline and 4 weeks
Change from Baseline MSQ v2.1 (the Migraine-Specific Quality of Life questionnaire v2.1)
Time frame: at baseline and 4 weeks
50% reduction as assessed by the mean VRS
Time frame: at 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Background: PubMed 28831756Lan L, Zhang X, Li X, Rong X, Peng Y. The efficacy of transcranial magnetic stimulation on migraine: a meta-analysis of randomized controlled trails. J Headache Pain. 2017 Aug 22;18(1):86. doi: 10.1186/s10194-017-0792-4.
- Background: PubMed 27785091Shehata HS, Esmail EH, Abdelalim A, El-Jaafary S, Elmazny A, Sabbah A, Shalaby NM. Repetitive transcranial magnetic stimulation versus botulinum toxin injection in chronic migraine prophylaxis: a pilot randomized trial. J Pain Res. 2016 Oct 7;9:771-777. doi: 10.2147/JPR.S116671. eCollection 2016.
- Background: PubMed 29504482Tassorelli C, Diener HC, Dodick DW, Silberstein SD, Lipton RB, Ashina M, Becker WJ, Ferrari MD, Goadsby PJ, Pozo-Rosich P, Wang SJ; International Headache Society Clinical Trials Standing Committee. Guidelines of the International Headache Society for controlled trials of preventive treatment of chronic migraine in adults. Cephalalgia. 2018 Apr;38(5):815-832. doi: 10.1177/0333102418758283. Epub 2018 Mar 4.
- Background: PubMed 29396646Steiner TJ, Lipton RB; Lifting The Burden: The Global Campaign against Headache. The Headache-Attributed Lost Time (HALT) Indices: measures of burden for clinical management and population-based research. J Headache Pain. 2018 Feb 2;19(1):12. doi: 10.1186/s10194-018-0837-3.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with Chronic Migraine, run by Peking Union Medical College 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 3 inclusion and 11 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 26 Jun 2018. 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. 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?
Contact Yuzhou Guan, MD (8613910081750, guanyz001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
50% reduction in the Number of Days with Headache (time frame: at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03568617, which also lists 4 linked publications.
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 26 Jun 2018.