Study of Low-level Laser Therapy in the Acute Treatment of Migraine

The San Francisco Clinical Research Center

Status and phase: Unknown; Phase 2

Conditions: Migraine Headache

Treatments: Device: Argus Migraine Treatment device

Study type: Interventional

Funder types: Other

Identifiers

NCT02969642

AP 1001

Details and patient eligibility

About

This study evaluates the treatment of migraine pain using low energy laser light to quench migraine signals issuing from the sphenopalatine ganglion (SPG).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Sham

Sham Comparator group

Description:

Sham low energy laser using approximately 1/1000 th energy of treatment laser.

Treatment:

Device: Argus Migraine Treatment device

Treatment

Active Comparator group

Description:

Treatment laser.

Treatment:

Device: Argus Migraine Treatment device