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

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ClinicalTrials.gov Identifier: NCT02969642
Recruitment Status : Recruiting
First Posted : November 21, 2016
Last Update Posted : December 2, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Migraine Headache Device: Argus Migraine Treatment device Phase 2

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Single-center, Sham-controlled, Single Attack Study of Laser Therapy to the Sphenopalatine Ganglion (SPG) in the Acute Treatment of Migraine
Study Start Date : March 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Sham Comparator: Sham
Sham low energy laser using approximately 1/1000 th energy of treatment laser.
Device: Argus Migraine Treatment device
treatment of Migraines targeting Sphenopalatine ganglion
Other Name: low energy laser therapy
Active Comparator: Treatment
Treatment laser.
Device: Argus Migraine Treatment device
treatment of Migraines targeting Sphenopalatine ganglion
Other Name: low energy laser therapy


Outcome Measures

Primary Outcome Measures :
  1. Differences between treatment groups in pain free rates at 2 hours post treatment. [ Time Frame: 2 hours post treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02969642


Locations
United States, California
San Francisco Clinical Research Center Recruiting
San Francisco, California, United States, 94109
Contact: Jerome Goldstein, MD    415-673-4600    JGoldstein@sfcrc.org   
Principal Investigator: Jerome Goldstein, MD         
Sponsors and Collaborators
The San Francisco Clinical Research Center
More Information

Responsible Party: The San Francisco Clinical Research Center
ClinicalTrials.gov Identifier: NCT02969642     History of Changes
Other Study ID Numbers: AP 1001
First Posted: November 21, 2016    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms