An interventional study of Sham Treatment Location and Verum Treatment Location in Episodic Migraine, sponsored by Theranova, L.L.C.. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-07-26.
Sponsored by Theranova, L.L.C. · Not applicable, Interventional, and Treatment
Clinical study to determine the responder rate of the TheraNova Migraine Treatment System to that of a sham control treatment.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 20 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Theranova, L.L.C. is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 5 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment at the bicep location
Device: Sham Treatment Location
Treatment at the hand location
Device: Verum Treatment Location
The device applies transcutaneous electrical nerve stimulation to the bicep
The device applies transcutaneous electrical nerve stimulation to the hand
Mean change in pain score
We will also assess the change in migraine pain before versus after treatment with the 100-mm Visual Analogue Scale (VAS), which is a continuum scale that patients can quantify their pain from none (0 mm) to extreme (100 mm) for both treatment sites. The mean score for each patient cohort will be calculated. We will also perform a sub analysis on women versus men.
Time frame: 4 months
Percent of subjects who are responders
For each subject treatment effectiveness will be assessed by both achieving pain relief (if the pain decreases from a 4-point visual rating scale (VRS) of 'severe' or 'moderate' at pre-treatment to 'mild' or 'none' at 120-min post-treatment) or pain-free ('none') status. The percent of subjects that experience a significant reduction in pain relief score (VRS) will be calculated for the verum and sham treatment sites.
Time frame: 4 months
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Theranova, L.L.C.