Clinical trial NCT03568617: rTMS for the Prevention Treatment of CM: a Single Arm Study
Official title: Repetitive Transcranial Magnetic Stimulation for the Prevention Treatment of Chronic Migraine: a Single Arm Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Migraine
Keywords: Transcranial Magnetic Stimulation
Migraine Disorders
Prophylaxis
Treatment Outcome
Brain
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* psychosis
* severe depression or anxiety
* drug or alcohol dependence
* pregnancy
* participating in other experiments at the same time

Primary outcomes:
measure: 50% reduction in the Number of Days with Headache
timeFrame: at 4 weeks
Secondary outcomes:
measure: 50% reduction in the Number of Migraine Days
timeFrame: at 4 weeks
measure: 50% reduction in the Number of Moderate/Severe Headache Days
timeFrame: at 4 weeks
measure: Conversion to episodic migraine
timeFrame: at 4 weeks
measure: The Subject's Global Impression of Change (SGIC)
timeFrame: at 4 weeks
measure: Change from Baseline HALT-28 (Headache-Attributed Lost Time - 28 days)
timeFrame: at baseline and 4 weeks
measure: Change from Baseline HIT-6 (Headache Impact Test-6)
timeFrame: at baseline and 4 weeks
measure: Change from Baseline MSQ v2.1 (the Migraine-Specific Quality of Life questionnaire v2.1)
timeFrame: at baseline and 4 weeks
measure: 50% reduction as assessed by the mean VRS
timeFrame: at 4 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: Shehata 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.
citation: Tassorelli 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.
citation: Steiner 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.