Headache, Migraine
Conditions
Brief summary
The purpose of this study is to evaluate the short-term effectiveness of combined occipital and supraorbital transcutaneous nerve stimulation in reducing migraine related pain.
Interventions
DEVICEOSTNS Neurostimulator
Non-invasive transcutaneous neurostimulation.
DEVICEPlacebo OSTNS Neurostimulator
Placebo non-invasive transcutaneous neurostimulation
Sponsors
Neurolief Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with confirmed diagnosis of migraine headache without aura or with typical migraine with aura (ICHD-II code 1.2.1 or 1.1). * Subjects with 1-6 migraine episodes per month in the last 2 months. * The subject is capable of understanding the study and to sign an informed consent.
Exclusion criteria
* Subjects who have concomitant epilepsy. * History of neurosurgical interventions. * Subjects with metal implants or shrapnel in their head, except for dental implants. * Subjects with implanted cardiac pacemaker, neurostimulators, surgical clips (above the shoulder line) or any medical pumps. * History of drug abuse or alcoholism. * History of medications overuse headache. * Participation in current clinical study or participated in a clinical study within 3 months prior to this study. * Skin lesion or inflammation at the region of the stimulating electrodes. * Personality or somatoform disorder. * Pregnancy or Lactation. * Women of reproductive age not using efficient contraceptive method. * History of cerebrovascular event.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain visual analogue scale (VAS) | 20-60 minutes of treatment. | The primary endpoint will be defined based on relative change (%) in pain VAS score from baseline to end of treatment without using pain relief medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Responder rate at 15 minutes of treatment | Baseline, 15 minutes of treatment | Responder rate at 15 minutes of treatment - Evaluated using pain VAS; a responder will be defined by a decrease of 50% or more in the pain VAS from baseline to end of treatment without using pain relief medication. |
| Sustained Responder rate at 24 hours post treatment | Baseline, 24 hours post treatment | Sustained responders rate at 24 hours: The percentage of study participants who will be defined as a responder at 2 hour and will not use pain relief medication or suffer from relapse (recurrence) within the subsequent 24 hours. |
| Headache relief rate- at 2 hours | Baseline, 2 hours | Headache relief rate- the percentage of subjects with a decrease in headache from severe or moderate to none or mild within 2 hours, before any pain relief medication. |
| Sustained headache relief at 24 hours | Baseline, 24 hours | The percentage of study participants who will be defined as having a headache relief at 2 hour and will not use pain relief medication or suffer from relapse (recurrence) within the subsequent 24 hours. |
| Pain free at 2 hours | Baseline, 2 hours | Percentage of subjects that are pain free at 2 hours |
| Responder rate at 20-60 minutes of treatment. | 20-60 minutes of treatment. | \- Evaluated using pain VAS; a responder will be defined by a decrease of 50% or more in the pain VAS from baseline to end of treatment without using pain relief medication. |
| Functional disability change 2 hours from end of treatment | Baseline, 2 Hours post treatment | Functional disability change 2 hours from end of treatment without using pain relief medication. |
| Time until use of pain relief medication. | Baseline- 24 hours. | Time until use of pain relief medication. |
| Presence of nausea, vomiting, photophobia, phonophobia. | Baseline- 24 hours. | Presence of nausea, vomiting, photophobia, phonophobia. |
| Percentage of subjects who completed the treatment. | Baseline-20 minutes of treatment | Percentage of subjects who completed at least 20 minutes the treatment. |
| Global impression of effect | Baseline- 24 hours. | Global impression of effect- A simple Likert-type verbal scale: very poor, poor, no opinion, good, very good. |
| Sustained pain freedom at 24 hours | Baseline, 24 hours | The percentage of study participants who will be defined as pain free at 2 hour and will not use pain relief medication or suffer from relapse (recurrence) within the subsequent 24 hours. |
Countries
Israel
Outcome results
None listed