A Single-center, Sham-controlled, Single Attack Study of Laser Therapy to the Sphenopalatine Ganglion (SPG) in the Acute Treatment of Migraine
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Differences between treatment groups in pain free rates at 2 hours post treatment.
Study Overview
Brief Summary
This study evaluates the treatment of migraine pain using low energy laser light to quench migraine signals issuing from the sphenopalatine ganglion (SPG).
Detailed Description
This is a double blinded, two arm study, comprising a sham laser and a treatment laser. The sham laser emits approximately 1/1000 the energy of the treatment laser.
It is presumed that pain relief from the treatment laser is achieved by exhausting the release of neurotransmitters from the SPG following laser stimulation. Subjects will be treated and subsequently queried at time intervals for their self-assessment of pain score (VAS). The time intervals include queries at 5 minutes through 2 hours post treatment. Subjects will be further contacted 24 hours and one month post treatment. Adverse events will be monitored and recorded.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •male or female
- •aged 18 or older;
- •subject diagnosed with migraine according to The International Classification of Headache Disorders- Version 3;
- •1-20 headache days per month;
- •history of at least moderate pain if migraine left untreated.
Exclusion Criteria
- •headache on greater than 25 days/month on average for preceding 3 months;
- •headache on greater than 25 days in present month;
- •headache attributed to: head or neck trauma, cluster headache, specific migraine variants such as basilar artery, ophthalmoplegic, hemiplegic, etc;
- •women of child bearing age not using acceptable method of contraception;
- •pregnant or nursing women;
- •history of malignancy of any organ
- •uncontrolled: hypertension, severe psychiatric disorders, or known use of narcotics, analgesic or alcohol abuse;
- •light sensitivity;
- •retinal disease;
- •intranasal pathology.
Arms & Interventions
Sham
Sham low energy laser using approximately 1/1000 th energy of treatment laser.
Intervention: Argus Migraine Treatment device (Device)
Treatment
Treatment laser.
Intervention: Argus Migraine Treatment device (Device)
Outcomes
Primary Outcomes
Differences between treatment groups in pain free rates at 2 hours post treatment.
Time Frame: 2 hours post treatment
Secondary Outcomes
No secondary outcomes reported