- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03568617
rTMS for the Prevention Treatment of CM: a Single Arm Study
22. juni 2018 opdateret af: Peking Union Medical College Hospital
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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
15
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: rTMS group
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
50% reduction in the Number of Days with Headache
Tidsramme: at 4 weeks
|
A Headache day is defined as a day with a headache that lasts at least 4 hours.
|
at 4 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
50% reduction in the Number of Migraine Days
Tidsramme: at 4 weeks
|
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.
|
at 4 weeks
|
50% reduction in the Number of Moderate/Severe Headache Days
Tidsramme: at 4 weeks
|
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.
|
at 4 weeks
|
Conversion to episodic migraine
Tidsramme: at 4 weeks
|
Defined as the proportion of subjects with fewer than 14 migraine or headache days per 4 weeks.
|
at 4 weeks
|
The Subject's Global Impression of Change (SGIC)
Tidsramme: at 4 weeks
|
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).
|
at 4 weeks
|
Change from Baseline HALT-28 (Headache-Attributed Lost Time - 28 days)
Tidsramme: at baseline and 4 weeks
|
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.
|
at baseline and 4 weeks
|
Change from Baseline HIT-6 (Headache Impact Test-6)
Tidsramme: at baseline and 4 weeks
|
HIT-6 is for capturing migraine-related disability with a 4-week recall period.
|
at baseline and 4 weeks
|
Change from Baseline MSQ v2.1 (the Migraine-Specific Quality of Life questionnaire v2.1)
Tidsramme: at baseline and 4 weeks
|
To evaluate the change in quality of life related to chronic migraine with a 4-week recall period.
|
at baseline and 4 weeks
|
50% reduction as assessed by the mean VRS
Tidsramme: at 4 weeks
|
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.
|
at 4 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
30. juni 2018
Primær færdiggørelse (Forventet)
31. december 2021
Studieafslutning (Forventet)
30. juni 2022
Datoer for studieregistrering
Først indsendt
4. juni 2018
Først indsendt, der opfyldte QC-kriterier
22. juni 2018
Først opslået (Faktiske)
26. juni 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. juni 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. juni 2018
Sidst verificeret
1. juni 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- rTMSCM-PUMCH
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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