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

A Single-center, Sham-controlled, Single Attack Study of Laser Therapy to the Sphenopalatine Ganglion (SPG) in the Acute Treatment of Migraine

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02969642

Enrollment

Registered

2016-11-21

Start date

2016-03-31

Completion date

2017-07-31

Last updated

2016-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine Headache

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.

Interventions

DEVICEArgus Migraine Treatment device

treatment of Migraines targeting Sphenopalatine ganglion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Differences between treatment groups in pain free rates at 2 hours post treatment.	2 hours post treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026