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rTMS for the Prevention Treatment of CM: a Single Arm Study

Primary Purpose

Chronic Migraine

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
rTMS
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Migraine focused on measuring Transcranial Magnetic Stimulation, Migraine Disorders, Prophylaxis, Treatment Outcome, Brain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    rTMS group

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    Conversion to episodic migraine
    Defined as the proportion of subjects with fewer than 14 migraine or headache days per 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).
    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.
    Change from Baseline HIT-6 (Headache Impact Test-6)
    HIT-6 is for capturing migraine-related disability with a 4-week recall period.
    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.
    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.

    Full Information

    First Posted
    June 4, 2018
    Last Updated
    June 22, 2018
    Sponsor
    Peking Union Medical College Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03568617
    Brief Title
    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

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 30, 2018 (Anticipated)
    Primary Completion Date
    December 31, 2021 (Anticipated)
    Study Completion Date
    June 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Peking Union Medical College Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Migraine
    Keywords
    Transcranial Magnetic Stimulation, Migraine Disorders, Prophylaxis, Treatment Outcome, Brain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    rTMS group
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    rTMS
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    50% reduction in the Number of Days with Headache
    Description
    A Headache day is defined as a day with a headache that lasts at least 4 hours.
    Time Frame
    at 4 weeks
    Secondary Outcome Measure Information:
    Title
    50% reduction in the Number of Migraine Days
    Description
    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.
    Time Frame
    at 4 weeks
    Title
    50% reduction in the Number of Moderate/Severe Headache Days
    Description
    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.
    Time Frame
    at 4 weeks
    Title
    Conversion to episodic migraine
    Description
    Defined as the proportion of subjects with fewer than 14 migraine or headache days per 4 weeks.
    Time Frame
    at 4 weeks
    Title
    The Subject's Global Impression of Change (SGIC)
    Description
    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).
    Time Frame
    at 4 weeks
    Title
    Change from Baseline HALT-28 (Headache-Attributed Lost Time - 28 days)
    Description
    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.
    Time Frame
    at baseline and 4 weeks
    Title
    Change from Baseline HIT-6 (Headache Impact Test-6)
    Description
    HIT-6 is for capturing migraine-related disability with a 4-week recall period.
    Time Frame
    at baseline and 4 weeks
    Title
    Change from Baseline MSQ v2.1 (the Migraine-Specific Quality of Life questionnaire v2.1)
    Description
    To evaluate the change in quality of life related to chronic migraine with a 4-week recall period.
    Time Frame
    at baseline and 4 weeks
    Title
    50% reduction as assessed by the mean VRS
    Description
    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.
    Time Frame
    at 4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yuzhou Guan, MD
    Phone
    8613910081750
    Email
    guanyz001@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hang Shen, MD
    Phone
    8613910131204
    Email
    shenhang12@sina.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28831756
    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.
    Results Reference
    background
    PubMed Identifier
    27785091
    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.
    Results Reference
    background
    PubMed Identifier
    29504482
    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.
    Results Reference
    background
    PubMed Identifier
    29396646
    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.
    Results Reference
    background

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    rTMS for the Prevention Treatment of CM: a Single Arm Study

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