To evaluate the effectiveness and safety of middle meningeal artery (MMA) embolization using non-adhesive materials SQUID 12 and SQUID 18 as a treatment method for patients with chronic resistant migraine.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Total endovascular embolization of the frontal and parietal branches (less often the occipital branch) of the middle meningeal artery (MMA) with its complete devascularization. In the case of unilateral pain localization, ipsilateral MMA embolization will be performed; in the case of bilateral pain localization, total embolization of both MMA branches will be performed.
Vedanta University Clinic
Bishkek, Bishkek, Kyrgyzstan
RECRUITINGnumber of migraine days
Change from baseline (during the screening period) in the number of migraine days over the previous 4 weeks, assessed at 3 months (12 weeks) post-surgery
Time frame: From previous 4 weeks before enrollment to the 3 months (12 weeks) post-surgery
The number of migraine days after surgery
The number of migraine days over the previous 4 weeks at 1 month (4 weeks), 2 months (8 weeks), 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) post-surgery
Time frame: From surgery up to 1 month (4 weeks), 2 months (8 weeks), 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) post-surgery
The average number of migraine days
The average number of migraine days over a 4-week period, calculated for the preceding 12-week period, assessed at visits 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) post-surgery
Time frame: From treatment every 12-week period, assessed at visits 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) post-surgery
Change from baseline (during the screening period) in the number of migraine days over the previous 4 weeks, assessed at 1 month (4 weeks), 2 months (8 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) post-surgery.
Change from baseline (during the screening period) in the number of migraine days over the previous 4 weeks, assessed at 1 month (4 weeks), 2 months (8 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) post-surgery.
Time frame: From screening up to 12 months
The number of headache days over the previous 4 weeks at 1 month (4 weeks), 2 months (8 weeks), 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) post-surgery
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The number of headache days over the previous 4 weeks at 1 month (4 weeks), 2 months (8 weeks), 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) post-surgery
Time frame: From surgery up 12 months (48 weeks) post-surgery
The average number of headache days over a 4-week period, calculated for the preceding 12-week period, assessed at visits 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) post-surgery.
The average number of headache days over a 4-week period, calculated for the preceding 12-week period, assessed at visits 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) post-surgery.
Time frame: From surgery up 12 months (48 weeks) post-surgery
Change compared to the baseline level (during the screening period) of the number of days with headaches in the previous 4 weeks, assessed at 1 month (4 weeks), 2 months (8 weeks), 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12
Change compared to the baseline level (during the screening period) of the number of days with headaches in the previous 4 weeks, assessed at 1 month (4 weeks), 2 months (8 weeks), 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) after the surgery.
Time frame: From screening up to 12 months
The proportion of patients whose number of migraine days in the previous 4 weeks decreases by 50% or more from the baseline level
The proportion of patients whose number of migraine days in the previous 4 weeks decreases by 50% or more from the baseline level (during the screening period) at 1 month (4 weeks), 2 months (8 weeks), 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) after the surgery.
Time frame: From surgery up 12 months (48 weeks) post-surgery
The proportion of patients whose average number of migraine days over the previous 12 weeks decreases by 50% or more
The proportion of patients whose average number of migraine days over the previous 12 weeks decreases by 50% or more at the visit at 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) after the surgery, compared to the baseline level (during the screening period).
Time frame: From screening up to 12 months
The proportion of patients whose number of headache days in the previous 4 weeks decreases by 50% or more from the baseline level
The proportion of patients whose number of headache days in the previous 4 weeks decreases by 50% or more from the baseline level (during the screening period) at 1 month (4 weeks), 2 months (8 weeks), 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) after the surgery.
Time frame: From screening up to 12 months
The number of days with headache intensity rated as "moderate" or "severe" in the previous 4 weeks
The number of days with headache intensity rated as "moderate" or "severe" in the previous 4 weeks at 1 month (4 weeks), 2 months (8 weeks), 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) after the surgery (according to the Clinical Trial Guidelines for Chronic Migraine Prevention, 2018).
Time frame: From surgery up 12 months (48 weeks) post-surgery
The average number of days in the previous 12-week period with headache intensity rated as "moderate" or "severe,"
The average number of days in the previous 12-week period with headache intensity rated as "moderate" or "severe," calculated and assessed at visits at 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) after the surgery.
Time frame: From surgery up 12 months (48 weeks) post-surgery
Change compared to the baseline level in the number of days with headache intensity rated as "moderate" or "severe" in the previous 4 weeks
Change compared to the baseline level in the number of days with headache intensity rated as "moderate" or "severe" in the previous 4 weeks, calculated at 1 month (4 weeks), 2 months (8 weeks), 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) after the surgery.
Time frame: From surgery up 12 months (48 weeks) post-surgery
The maximum intensity of migraine headache in the previous 4 weeks, as determined by the patient using a 10-point numerical rating scale
The maximum intensity of migraine headache in the previous 4 weeks, as determined by the patient using a 10-point numerical rating scale, assessed at 1 month (4 weeks), 2 months (8 weeks), 3 months (12 weeks), and 6 months (24 weeks) after the surgery.
Time frame: From surgery up 6 months (24 weeks) post-surgery
The number of days with symptoms associated with migraine (nausea, vomiting, photophobia, phonophobia) in the previous 4 weeks
The number of days with symptoms associated with migraine (nausea, vomiting, photophobia, phonophobia) in the previous 4 weeks, assessed at 1 month (4 weeks), 2 months (8 weeks), 3 months (12 weeks), and 6 months (24 weeks) after the surgery.
Time frame: From surgery up 6 months (24 weeks) post-surgery
The total score on the HIT-6 scale
The total score on the HIT-6 scale at 1 month (4 weeks), 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) after the surgery.
Time frame: From surgery up 12 months (48 weeks) post-surgery
The total score on the MIDAS scale
The total score on the MIDAS scale at 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) after the surgery.
Time frame: From surgery up 12 months (48 weeks) post-surgery
Change in the total score on the HIT-6 scale
Change in the total score on the HIT-6 scale at 1 month (4 weeks), 2 months (8 weeks), 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) after the surgery compared to the baseline level.
Time frame: From surgery up 12 months (48 weeks) post-surgery