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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Migraine||Device: rTMS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
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
|Contact: Yuzhou Guan, MDfirstname.lastname@example.org|
|Contact: Hang Shen, MDemail@example.com|