ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03568617
Recruitment Status : Not yet recruiting
First Posted : June 25, 2018
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment Phase
Chronic Migraine Device: rTMS Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation for the Prevention Treatment of Chronic Migraine: a Single Arm Study
Estimated Study Start Date : June 30, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: rTMS group Device: rTMS
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 Measures :
  1. 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.


Secondary Outcome Measures :
  1. 50% reduction in the Number of Migraine Days [ Time Frame: 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.

  2. 50% reduction in the Number of Moderate/Severe Headache Days [ Time Frame: 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.

  3. Conversion to episodic migraine [ Time Frame: at 4 weeks ]
    Defined as the proportion of subjects with fewer than 14 migraine or headache days per 4 weeks.

  4. The Subject's Global Impression of Change (SGIC) [ Time Frame: 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).

  5. Change from Baseline HALT-28 (Headache-Attributed Lost Time - 28 days) [ Time Frame: 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.

  6. Change from Baseline HIT-6 (Headache Impact Test-6) [ Time Frame: at baseline and 4 weeks ]
    HIT-6 is for capturing migraine-related disability with a 4-week recall period.

  7. Change from Baseline MSQ v2.1 (the Migraine-Specific Quality of Life questionnaire v2.1) [ Time Frame: at baseline and 4 weeks ]
    To evaluate the change in quality of life related to chronic migraine with a 4-week recall period.

  8. 50% reduction as assessed by the mean VRS [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568617


Contacts
Contact: Yuzhou Guan, MD 8613910081750 guanyz001@163.com
Contact: Hang Shen, MD 8613910131204 shenhang12@sina.com

Sponsors and Collaborators
Peking Union Medical College Hospital

Publications:
Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03568617     History of Changes
Other Study ID Numbers: rTMSCM-PUMCH
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018

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

Keywords provided by Peking Union Medical College Hospital:
Transcranial Magnetic Stimulation
Migraine Disorders
Prophylaxis
Treatment Outcome
Brain

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases