The goal of this clinical trial is to determine the efficacy of a new, improved neuromodulation device that can be worn on the head and neck to relieve migraine pain. To measure efficacy, investigators will compare how measured outcomes resulting from active stimulation with this device compare to those of sham treatment.
The objective of this study is to examine the extent to which a transcutaneous electrical nerve stimulation (TENS) device safely helps participants with acute migraines reduce migraine pain intensity, achieve pain freedom, and experience sustained pain freedom. The TENS device attaches to a gel pad that can be worn in one of three placement locations to stimulate sensory nerves implicated in migraine pain. The TENS device outputs two active electrical waveforms that differ in stimulation intensity but can both be used to address migraine pain through a 1-hour treatment session. To achieve the study objective, investigators will perform a randomized controlled trial (RCT) with a 3x3 factorial design in which participants will be randomized across the 3 TENS device placement options and each participant will test 3 waveforms: two active waveforms and a sham waveform. Each waveform will be used in a distinct migraine episode. The investigators will evaluate the study aims for each active treatment (six in total) compared to its corresponding sham.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
Use of TENS device for 1 hour during each migraine episode.
Hinge Health, Inc.
San Francisco, California, United States
Safety/Adverse Events
Safety will be measured by comparing the number of reportable adverse events, with particular focus on serious adverse events, that occur for the 6 active treatments versus the corresponding sham. Adverse events will be assessed by asking participants of any symptoms or medical issues experienced since the last interaction or activity in the study. Participants will report details of the event, its circumstances, the severity, and outcome/resolution of the event in the post-treatment surveys. The events will be adjudicated by the Study Physician, who will determine seriousness, relatedness and reportability.
Time frame: Pre-treatment, 1, 2, and 24 hours post-treatment.
Pain Relief at 1 hour (Clinical Efficacy)
Pain relief will be measured by asking participants to report pain intensity using the 11-point Numeric Rating Scale (NRS) in the pre-treatment survey and in the post-treatment survey 1 hour after the initiation of treatment. NRS pain levels will be converted into categorical ratings of pain severity according to the following mapping between NRS and a 4-point Likert scale: (0-1 NRS =\> no pain; 2-3 NRS =\> mild pain; 4-6 NRS =\> moderate pain; 7-10 NRS =\> severe pain). Pain relief constitutes a change in pain level from severe or moderate pain to mild or no pain. The percentage of participants who achieve pain relief in the active and sham treatments will be compared. Six comparisons will be performed in total, for the 6 active treatments (3 placements x 2 active waveforms).
Time frame: Pre-treatment, 1-hour post-treatment
Pain Relief at 2 hours
Pain relief will be measured by asking participants to report pain intensity using the 11-point Numeric Rating Scale (NRS) in the pre-treatment survey and in the post-treatment survey 2 hours after the initiation of treatment. NRS pain levels will be converted into categorical ratings of pain severity according to the following mapping between NRS and a 4-point Likert scale: (0-1 NRS =\> no pain; 2-3 NRS =\> mild pain; 4-6 NRS =\> moderate pain; 7-10 NRS =\> severe pain). Pain relief constitutes a change in pain level from severe or moderate pain to mild or no pain. The percentage of participants who achieve pain relief in the active and sham treatments will be compared. Six comparisons will be performed in total, for the 6 active treatments (3 placements x 2 active waveforms).
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Time frame: Pre-treatment, 2 hours post-treatment
Pain Freedom at 2 hours
Pain freedom will be defined as a reduction in pain severity from mild, moderate, or severe at baseline to none at 2 hours, using the Numeric Rating Scale (NRS) mapped to a 4-point Likert scale, as based on literature. Six comparisons will be performed in total, for the 6 active treatments (3 placements x 2 active waveforms) vs the corresponding sham.
Time frame: Pre-treatment, 1, 2 hours post-treatment.
Sustained Pain Freedom
Sustained pain freedom is defined as pain freedom at 24 hours without the use of anti-migraine medication or relapse during those 24 hours. Sustained pain freedom at 24 hours will be measured using the same four point Likert scale as used to measure pain freedom at 2 hours. Six comparisons will be performed in total, for the 6 active treatments (3 placements x 2 active waveforms) vs the corresponding sham.
Time frame: 24-hours post-treatment.