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

Migraine Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02969642
• Other study ID #: AP 1001
• Status: Recruiting
• Phase: Phase 2
• First received: October 20, 2016
• Last updated: December 1, 2016
• Start date: March 2016
• Est. completion date: July 2017

Study information

• Verified date: December 2016
• Source: The San Francisco Clinical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Headache

Intervention

Device:
• Argus Migraine Treatment device
treatment of Migraines targeting Sphenopalatine ganglion

Locations

Country	Name	City	State
United States	San Francisco Clinical Research Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
The San Francisco Clinical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences between treatment groups in pain free rates at 2 hours post treatment.		2 hours post treatment	No